Abstract of dissertation entitled The Use of Topical Anesthesia to Reduce Pediatric IV Cannulation Pain in an Emergency Department Submitted by Lai Yat Ming for the degree of Master of Nursing at The University of Hong Kong in August 2012 Intravenous cannulation of pediatric patients is a common procedure in emergency departments. It is a useful tool to facilitate medical investigations and drug administration. However, the pain induced by the procedure can lead to patient distress and bother the nursing and medical procedures afterwards. There are many kinds of topical anesthesia but no relevant evidence-based guideline for their use is available for the emergency departments. This dissertation synthesizes the available evidence in the literature to establish an evidence-based guideline for the use of topical anesthesia to reduce pain caused by pediatric intravenous cannulation in an emergency department. The communication, implementation and evaluation plan are also developed.
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Abstract of dissertation entitled
The Use of Topical Anesthesia to Reduce Pediatric
IV Cannulation Pain in an Emergency Department
Submitted by
Lai Yat Ming
for the degree of Master of Nursing
at The University of Hong Kong
in August 2012
Intravenous cannulation of pediatric patients is a common procedure in
emergency departments. It is a useful tool to facilitate medical investigations and
drug administration. However, the pain induced by the procedure can lead to
patient distress and bother the nursing and medical procedures afterwards. There
are many kinds of topical anesthesia but no relevant evidence-based guideline for
their use is available for the emergency departments. This dissertation synthesizes
the available evidence in the literature to establish an evidence-based guideline for
the use of topical anesthesia to reduce pain caused by pediatric intravenous
cannulation in an emergency department. The communication, implementation
and evaluation plan are also developed.
A systematic literature review was conducted from 30th August to 2nd September,
2011. A number of electronic databases, including PubMed, CINAHL Plus and
Embase were searched. Thirteen eligible randomized controlled trials were
identified. They were integrated into a table of evidence and were critically
appraised by the SIGN Methodology Checklist. After synthesis of evidence, it is
suggested that needleless anesthesia with apparatus assistance significantly
reduced pain as early as in five minutes. Patients should however be observed for
two hours after the administration of anesthesia for signs of adverse effects.
The implementation potential, in terms of the transferability, feasibility and
cost-benefit ratio, was examined. Among the anesthesia devices, the Jet lidocaine
device has satisfactory transferability, feasibility and cost-benefit ratio. The
evidence is then translated into a practice guideline with the recommendations
scored based on the “SIGN 50: A guideline developer’s handbook”.
A fourteen-month implementation plan,including a communication plan, a pilot
study and an evaluation plan is developed. The communication phase lasts for
three months and the stakeholders including the Chief of Service, Department
Operation Manager, Advanced Practice Nurses, frontline healthcare
professionals and the pharmacy department are identified. The pilot plan lasts for
ten weeks, which includes a two-week training period, a three-week
observational period for baseline measurement, a three-week intervention period
and an eight-week amendment period. The pilot study collects data regarding the
pain level at baseline and identifies unanticipated problems in the guideline.
Amendments would be made accordingly and the revised guideline would be
sent for ethical approval before the implementation phase.
In the evaluation plan, the primary outcome for the innovation is the level of pain.
The secondary outcomes are the admission rate and length of hospital stay. Other
outcomes are the satisfaction of healthcare professionals, utilization rate and cost.
It is expected that the cannulation pain, admission rate and length of hospital stay
would be lower with the application of topical anesthesia.
The Use of Topical Anesthesia to Reduce Pediatric
IV Cannulation Pain in an Emergency Department
by
Lai Yat Ming Bachelor of Nursing (Honours) H.K.U.
A dissertation submitted in partial fulfillment of the requirement for
the degree of Master of Nursing
at The University of Hong Kong.
August 2012
i
Declaration
I declare that this dissertation represents my own work, except where due
acknowledgement is made, and that it has not been previously included in a thesis,
dissertation or report submitted to this University or to any other institution for a
degree, diploma or other qualifications.
Signed:___________________________
Mr Lai Yat Ming
ii
Acknowledgements
In the writing process of this dissertation, I would like to thank Dr. Daniel Fong,
an Associate Professor as well as my academic supervisor. He shows great
patience and provides timely and inspiring advice for me for many times.
Moreover, he also criticizes the possible flaws and suggests logical flow to
improve the integrity of the dissertation.
I would also like to express my gratitude to academic and administrative staff of
School of Nursing, The University of Hong Kong. Their professional teaching
attitude and efficient administrative services facilitate my school life in the master
course.
iii
Table of Contents
Declaration ……………………………………………………………………………… i
Acknowledgement …………………………………………………………………………ii
Table of contents …………………………………………………………………………iii
List of appendices …………………………………………………………………………v
CHAPTER 1 – INTRODUCTION
1.1 BACKGROUND …………………………………………………………... 1
1.2 AFFIRMING THE NEED ………………………………………………… 3
1.3 OBJECTIVES AND SIGNIFICANCE …………………………………….. 5
CHAPTER 2 – CRITICAL APPRAISAL
2.1 SEARCH AND APPRAISAL STRATEGIES ………………………………. 7
Mcdonald, Bulsara, & Huijer, 2007). WBFS has high agreement with the visual
analog scale and has been validated for use in children (Anthony & Schanberg,
2007; Garra et al., 2010).
The secondary patient outcomes would be the number of admissions of the target
population and the length of stay. Data of admission can be collected in the
38
pediatric intravenous cannulation record (Appendix 16). The length of stay would
be obtained by the electronic patient record. One of the group members would be
responsible for extracting the data.
The healthcare provider outcome would be staff satisfaction. Staff satisfaction
would be assessed with a self-reported survey (Appendix 18). The survey has a
5-point Likert scale, from 1(strongly disagree) to 5(strongly agree). A mean score
would be calculated as the final score of the survey. The higher the score is, the
more satisfied the staff member is about the innovation.
The system outcomes would be the utilization rate of the innovation and cost of
the innovation. The utilization rate would be obtained by the electronic patient
record. Cost would be calculated by the account record, which is kept by the
secretary of the target department and the ward manager, for material cost and
compensation hour record for staff cost. An A&E secretary would help to extract
the records.
Other demographic data would be collected and documented in the pediatric
intravenous cannulation record (Appendix 16).
39
4.3.2 Nature and number of clients to be involved
The inclusion and exclusion criteria of clients would be the same as the protocol
discussed before. All pediatric cases who need intravenous cannulation would be
included, except those who have mental illness, allergy of lidocaine or have
received analgesia.
From the previous studies, it is found that a minimum reduction of ten millimeters
in VAS (equivalent to one unit in the NTWC pain assessment tool, see Appendix 6)
would be considered as an important effect of the innovation (Powell, Kelly
&Williams, 2001). Assuming the standard deviation be three units, effect size d be
0.9, power be 0.8 and alpha be 0.05, the estimated sample size would be 73. Since
there are about 1565 eligible subjects per year, the expected time to achieve 73
subjects would be three weeks.
However, with special considerations mentioned in the next section, the total
number of patients involved would be 783. Since there are around one hundred
frontline staffs in the emergency department, three weeks may not be enough to
provide adequate exposure for all staff. On the other hand, it is difficult to reflect
40
the secondary outcomes and cost within such a short period. Therefore, a
twenty-six-week implementation period would be preferred. As the estimated
number of eligible clients would be 1,565 annually, the estimated number of
patients to be enrolled in the implementation period would be 783.
4.3.3 Timing and frequency of taking measurements
Primary outcome would be measured just after each procedure, and the data of
secondary outcomes and cost would be collected at the end of the implementation
period, i.e. week 26. Staff satisfaction and utilization rate would be collected in
the middle (week 13) and the end of implementation phase (week 26).
4.3.4 Data analysis
In the fifty-ninth week of the implementation plan, data would be entered to a
computer database and analyzed by one of the working group members who has
been trained with the IBM SPSS software. Two-tailed t-test would be used to
determine if the pain score is reduced in the innovation group compared to the one
in the current practice, i.e. the one obtained in the observational period in the pilot
study. Two-tailed t-test would be used to determine if the admission rate and the
length of hospital stay would be reduced when compared with that during the
41
same period in the last year. The nominal level of significance of the significant
tests mentioned above would be 0.05. The staff satisfaction towards the
innovation in week 13 and week 26 would be estimated with 95% confidence
interval. 95% confidence interval would also be used to determine the utilization
rate estimation. Cost would be calculated by the sum of the setup cost. It includes
the personnel cost and the material cost for the purchases of devices and materials,
and the miscellaneous cost for the purchase of ink, paper, etc.
4.3.5 Basis for adopting innovation
It is a crucial part of the evaluation to determine if the innovation would be
adopted. The working group members would hold an evaluation meeting with the
COS and the DOM at the end of the evaluation period, i.e. sixtieth week. During
the meeting, they would discuss about the results from the data analysis. As
mentioned, a minimum reduction of one unit of pain in the NTWC pain
assessment tool compared to the current practice would be considered as a
significant difference. For the admission rate and the length of hospital stay, it is
estimated that the innovation can provide a reduction of 10% in the admission rate
and 0.5 patient-day of hospital stay compared to the same period last year. Staff
should at least have a mean satisfaction score of three out of the 5-point Likert
42
scale, meaning that they do not disagree with the use of the innovation. The
utilization rate should be over 80%. And the actual cost of innovation should be
estimated by the setup cost (HK$ 12,783.6), material cost for pilot and
implementation periods (HK$ (783+80)X(2.1+4)X7.8= HK$41,061.5), and the
miscellaneous cost (HK$ 1560), i.e. HK$44405.1.
43
APPENDICES Appendix 1 Searching Strategies for Existing Guidelines/ Protocols
Guideline Database
National Guideline
Clearinghouse (NGC)
CMA InfoBase
Health Services/
Technology Assessment
Text (HSTAT)
Guidelines Advisory
Committee (GAC)
Scottish Intercollegiate
Guideline Network (SIGN)
National Insitute for
Clinical Excellence
(NICE)
New Zealand
Guidelines Group
(NGZZ)
Guidelines International
Network
Date of Search 30/8/2011 Keywords: anesthesia AND Vein catheterization OR Venous catheterization OR Vascular access OR Venous access OR Venipuncture OR Venepuncture OR cannulation OR needle insertion
0 0 0 0 0 0 0 0
Appendix 2 Searching Strategies for Systematic Reviews Database for Systematic Reviews Cochrane Library Date of Search 2/9/2011 Searching Criteria Number of Reviews 1. Keywords:
Topical anesthesi* OR Local anesthesi* 14
2. Keywords: Vein catheterization OR Venous catheterization OR Vascular access OR Venous access OR Venipuncture OR Venepuncture OR cannulation OR needle insertion
48
3. Keywords: Emergency department OR emergency service OR emergency setting OR ED
91
1 AND 2 AND 3 0
44
Appendix 3 Searching Strategies for Primary Studies
Database PubMed CINAHL Embase
Date of Search 2/9/2011 30/8/2011 2/9/2011
Searching Criteria Number of Articles
1. Keywords:
Topical anesthesi* OR Local
anesthesi*
20178 967 35350
2. Keywords:
Vein catheterization OR Venous
catheterization OR Vascular access
OR Venous access OR
Venipuncture OR Venepuncture
OR cannulation OR needle
insertion
207432 4769 41331
3. Keywords:
Emergency department OR
emergency service OR emergency
setting OR ED
808895 35800 88493
1 AND 2 AND 3 52 3 32
Subtotal 87
Limited to :
Randomized Controlled Trial
20
3
(only 1 result in
automatic limits,
but all 3 articles
are RCTs)
18
Limited to :
Ages: All Infant: birth-23 months, All
Child: 0-18 years, Newborn: birth-1
month, Infant: 1-23 months, Child: 6-12
years, Adolescent: 13-18 years
(PubMed);
Age Groups: Infant, Newborn: birth-1
month, Infant: 1-23 months, Child,
Preschool: 2-5 years, Child: 6-12 years,
Adolescent: 13-18 years, All infant, All
Child (CINAHL);
Human Age Groups: infant <to one
year> or child <unspecified age> or
10 3 11
45
preschool child <1 to 6 years> or school
child <7 to 12 years> or adolescent <13
to 17 years> (Embase)
Articles remained after screening title
and abstract 8 2 8
Full text available or relevant data
available in abstract 8 2 8
Articles remained after screening full
paper 7 1 8
Articles remained after removal of
duplicated with other databases 7 0 5
Plus articles from references of eligible
studies 1
Total 13
46
Appendix 4
Table of Evidence
Study, Year
(Number in
List of
articles)
Study Design,
Number of
subjects,
Level of
Evidence
Subject
characteristics
(Intervention vs
Comparison)
Intervention Comparison/
Control
Length
of
follow
up
Outcome measures
(Unit / scale of
measurement)
Effect size
(Intervention vs Comparison)
Arendts et
al., 2008,
(1)
RCT, n=203,
1+
Mean age: 4.9
vs 4.8; Range:
0-12 vs 0-13
Sex:
M=38vs55,
F=39vs42
EMLA applied
on the right
dorsal hand and
antecubital fossa
under occlusive
dressing
Cannulating
staff choose site
of cannulation
n=93
Withdrawn n=13
Analyzed n=80
AnGEL applied
on the right
dorsal hand and
antecubital fossa
under occlusive
dressing
Cannulating
staff choose site
of cannulation
n=110
Withdrawn n=13
Analyzed n=97
60 min Primary:
1. Initial cannulation
success rates (%)
Secondary:
2. Safety (No. of
adverse events)
1. 74 vs 75 (p=0.82)
2. 3(4%) vs 13 (13%)
Auerbach
et al., 2009,
(2)
RCT, n=197,
1+
Mean age
±SD:
(a)11.7±4.0 vs
(a) Jet lidocaine
injection
n=75
(b) Jet placebo
(normal saline)
injection
30 sec
- 5 min
Primary:
1. Pain by CAS
(mm)
1. Pain score (95% CI)
i. (a) 12(7-17) vs (b)
27(20-34) (p<0.01)
47
(b)12.4±4.2 vs
(c)12.5±4.1
Sex (%):
M= (a)52 vs
(b)52 vs (c)40,
F= (a)48 vs
(b)48 vs (c)60
n=75
(c) no
pretreatment
n=47
i. Device
application
ii. Needle
insertion
iii. 5 min after
needle
Secondary:
2. Safety (No. of
adverse events)
ii. (a) 28(21-35) vs
(b) 24(27-41) vs
(c) 52(43-60)
(a vs b: p=0.23; a vs c:
p<0.01; b vs c: p<0.01)
iii. (a) 12(7-17) vs (b)
12(7-17) vs (c) 15(8-21)
(p>0.05)
2. None.
Costello et
al., 2006,
(3)
RCT, n=127,
1+
Mean age:
(a)12.7 vs
(b)13.3 vs
(c)13.2
Sex (%):
M= (a)41 vs
(b)48 vs (c)50,
F= (a)59 vs
(b)52 vs (c)50
(a) ethyl vinyl
chloride
vapocoolant
spray
n=37
(b) isopropyl
alcohol spray
n=48
(c) no
pretreatment
n=42
5 sec Primary:
1. Pain in VAS
(mm)
Secondary:
2. Initial cannulation
success rate (%)
3. Safety (No. of
adverse events)
1. (a)34±26 vs (b)33±25 vs
(c)31±25 (p=0.8)
2. (a)78 vs (b)85 vs (c)86
(p=0.6)
3. None.
Kim et al.,
1999, (4)
RCT, n=50,
1-
Mean age:
11.4 vs 10.6
Sex:
M= 10(45%)
vs 11(44%),
2% lidocaine
with 1:100,000
epinephrine
(Iontocaine) in
drug electrode
0.9% saline
solution with
1:100,000
epinephrine in
drug electrode
After
i.v.
cannul
ation
to 48
Primary:
1. Pain in
iontophoresis
2. Pain in
cannulation in
1. No discomfort:
9(39%) vs 6(22%)
Slightly uncomfortable:
13(57%) vs 17(63%)
Uncomfortable: 1(4%) vs
48
F= 12(55%) vs
14(56%)
administered by
a
battery-operated
iontophoresis
unit
n=23
withdrawn n=1
analyzed n=22
administered by
a
battery-operated
iontophoresis
unit
n=27
withdrawn n=2
analyzed n=25
hrs VAS (unit)
Secondary:
3. Cannulation
success rates (%)
4. Safety (No. of
adverse events)
2(7%)
Very uncomfortable:
0(0%) vs 1(4%)
Painful: 0(0%) vs 1(4%)
2. Median (25th and 75%
percentiles):
0.5(0-2) vs 4(2-8) (p=0.002)
3. 77 vs 84
4. 6 vs 2
Luhmann et
al., 2004,
(5)
RCT, n=69,
1++
Overall Mean
Age ± SD
(range):
12.1±4.5
(4.3-20.3)
Overall sex
(%):
M=39, F=61
Buffered
lidocaine
administered
subcutaneously,
5min before
cannulation
n=34
ELA-Max
applied to skin
with tegaderm
occlusion, 30
min before
cannulation
n=35
5min –
30 min
Primary:
1. Pain in
cannulation in
VAS (unit)
2. Anxiety in
cannulation in
VAS (unit)
1. Children:
3.4±2.9 vs 2.6±2.5 (p=0.19)
Parents:
3.3±2.5 vs 2.5±2.2 (p=0.17)
Blinded Observer:
2.0±1.4 vs 2.5±1.8 (p=0.2)
2. Children:
2.9±3.2 vs 2.0±2.0 (p=0.18)
Parents:
2.6±2.7 vs 2.2±2.0 (p=0.50)
Blinded Observer:
3.3±2.5 vs 3.3±2.5 (p=0.96)
Mann et al.,
2007, (6)
RCT, n=101,
1-
Age
range:3-15
EMLA
application
Nitrous oxide
administration
About
12
Primary:
1. Pain in
1. Median(IQR):
1(1-2) vs 1(0-2) (p = 0.85)
49
n=45 n=56 minute
s
cannulation in
Wong-Baker
FACES pain
rating scale (unit)
Secondary:
2. Safety (No. of
adverse events, %,
95%CI)
2. 1 (2.2, 0.1-13.2) vs 8(14.3,
6.8-26.8)
Newbury et
al., 2009,
(7)
RCT,n=679,
1++
Mean Age
(SD):
6y9m(4y3m)
vs 7y0m
(4y2m)
Sex:
M=168(50%)
vs 187(54%),
F=162(48%)
vs 153(45%)
Amethocaine
(Ametop)
applied and
covered with
transparent
adhesive
dressing for 45
min
n=337
EMLA applied
and covered
with transparent
adhesive
dressing for 90
min
n=342
45-90
min
Primary:
1. Initial cannulation
success rate (%)
Secondary:
2. Pain in VAS and
FLACC (units)
1. 75.8 vs 73.9 (p=0.56)
2. Pain score shown in graph,
exact numeric score not given.
But statistically insignificant.
(p>0.05)
Ramsook et
al., 2001,
(8)
RCT,n=222,
1+
Median Age: 9
vs 10
Sex (%):
M=44 vs 47,
F=56 vs 53
Ethyl chloride
aerosol sprayed
5 sec before
cannulation
n=114
Isopropyl
alcohol aerosol
sprayed 5 sec
before
cannulation
5 sec Primary:
1. Pain in
cannulation with
Faces Pain Scale
and Numeric Pain
1. Median:
3-5yr-old= 6 vs 6,
6-12yr-old= 4 vs 4,
>12yr-old= 2 vs 3
2. Median: 0 vs 0
50
3-5yr-old n=25,
6-12yr-old
n=63,
>12yr-old n=26
n=108
3-5yr-old n=19,
6-12yr-old
n=59,
>12yr-old n=30
Scale (units)
2. Pain in spray with
Faces Pain Scale
and Numeric Pain
Scale (units)
Secondary:
3. Initial cannulation
success rate (%)
3. 76 vs 85
Shavit et
al., 2009,
(9)
RCT,n=40,
1+
Mean Age:
13.6 vs 14.12
1-2g of LidoDin
applied to
antecubital
fossa, covered
with dressing for
60 min then
removed
Cannulation
after several
minutes of
cream removal
n=20
1-2g of EMLA
applied to
antecubital
fossa, covered
with dressing for
60 min then
removed
Cannulation
after several
minutes of
cream removal
n=20
1-5
min
after
cream
remov
al and
immed
iately
after
cannul
ation
Primary:
1. Pain in VAS
(mm)
2. Safety in
Numerical Scale
for Skin
Assessment (unit)
i. Erythema
ii. Edema
iii. Pruritus
1. Patient assessment, Mean
(SD):
11.1(7.2) vs 10.5(10.5)
(p=0.87)
Nurse assessment, Mean (SD):
7(6.5) vs 8(8.9) (p=0.69)
2. Mean:
i. 0.35 vs 0.25 (p=0.73)
ii. 0.5 vs 0.4 (p=0.75)
iii. 0 vs 0
Singer et
al., 2008,
(10)
RCT,n=40,
1+
Mean age
(SD):
9.3(4.3) vs
Lidocaine 70mg/
tetracaine 70mg
topical patch
Placebo patch
applied over
vein at triage.
Just
after
cannul
Primary:
1. Pain in VAS
(mm) or
1. Median score (IQR):
All patients:
18(1-40) vs 35(20-59)
51
10.8(4.5)
Sex:
M= 13(65%)
vs 13(45%),
F= 7(35%) vs
7(35%)
applied over
vein at triage.
Patch removed
before
cannulation
n=20
Patch removed
before
cannulation
n=20
ation Wong-Baker
FACES pain
rating scale (unit)
Secondary:
2. No. of successful
cannulation
3. No. of very easy
cannulation
4. No. of adverse
events
i. Erythema
ii. Edema
iii. Pruritus
(p=0.04)
Patients using VAS:
11(0-30) vs 39(20-61)
(p=0.01)
2. 18(90%) vs 17(85%) (p=1.00)
3. 14(70%) vs 18(90%) (p=0.24)
4. Erythema 6(30%) vs 6(30%)
(p=1.00)
Edema: 0 vs 0
Pruritus: 0 vs 0
Singer et
al., 2006,
(11)
RCT,n=61,
1+
Mean age
(95%CI):
27(19,35) vs
27(20,35)
No. of
children:
15(50%) vs
15(50%)
Sex:
M= 17(57%)
Laser applied
over vein for
600
microseconds.
0.5g ELA-Max
cream applied
by cotton-tipped
applicator.
Cream wipe off
after 5 min.
Sham laser
applied over
vein for 600
microseconds.
0.5g ELA-Max
cream applied
by cotton-tipped
applicator.
Cream wipe off
after 5 min.
Just
after
cannul
ation
to one
week
later
Primary:
1. Pain for (a)
laser/sham
application and
(b) venous
cannulation in
VAS (mm) for
subject aged ≧8,
Smiley Analog
Scale (unit) for
1. Mean score (95%CI):
Adult:
(a) 0 vs 0
(b) 5.6(1.4,9.8) vs
35.9(21.1,50.6)
Children:
(a) 3.1(0,7.5) vs 0
(b) 14.4(3.9,25.0) vs
40.9(29.3,52.4)
All patients:
52
vs 14(45%),
F= 13(43%) vs
17(55%)
n=30 n=31 subject aged 3-7,
CHEOPS (unit)
for subject aged
<3
Secondary:
2. No. of successful
cannulation
3. No. of very easy
cannulation
4. No. of adverse
events
(a) 1.5(0,3.7) vs 0
(b) 10.0(4.4,15.6) vs
38.3(29.3,42.2)
2. Adult: 14(93.3%) vs
14(87.5%) (p=0.23)
Children: 13(87%) vs 8(53%)
(p=0.006)
All patients: 27(90%) vs
22(71%) (p=0.001)
3. Adult: 12(80.0%) vs
10(62.5%) (p=0.43)
Children: 10(67%) vs 7(47%)
(p=0.20)
All patients: 22(73) vs 17(54)
(p=0.01)
4. Adult: 0 vs 0
Children: 0 vs 0
All patients: 0 vs 0
Skarbek-Bo
rowska et
al., 2006,
(12)
RCT,n=77,
1++
Mean
Age(SD):
13.08(2.39) vs
12.62(2.55)
Sex:
sonophoresis
with SonoPrep
4% liposomal
lidocaine cream
(ELA-Max)
sonophoresis
with SonoPrep
placebo cream
applied 5 min
before
Just
after
ultraso
und
applica
Primary:
1. Pain in VAS
(mm)
Secondary:
2. Frequency of skin
1. Mean Score(SD)
Child: 2.29(1.82) vs
3.23(2.23) (p=0.023)
Parent: 2.47(2.18) vs
3.39(2.38) (p=0.038)
53
M=17(45%) vs
20(51%),
F=21(55%) vs
19(49%)
applied 5 min
before
cannulation
n=38
cannulation
n=39
tion to
48
hours
redness
i. Immediate after
sonication
ii. 24 hours after
sonication
3. Sensation of
device
(Frequency)
4. Difficulty in
cannulation
(Frequency)
Nurse: 1.29(0.71) vs
1.49(0.60) (p=0.103)
2. Frequency (%):
i. No effect: 19(50.0) vs
22(56.4)
Minor: 18(47.4) vs 16(41.0)
Significant: 1(2.6) vs 1(2.6)
(p= 0.821)
ii. No effect: 37(97.4) vs
37(97.4)
Minor: 1(2.6) vs 1(2.6)
Significant: 0 vs 0
(p=1.00)
3. No discomfort:
21(55%) vs 22(56%)
Little uncomfortable:
11(29%) vs 11(28%)
Uncomfortable: 5(13%) vs
5(13%)
Very uncomfortable:
1(3%) vs 0(0%)
It hurt: 0(0%) vs 1(3%)
(p=1.00)
54
4. Easy: 31(81.6%) vs 35(89.7%)
Slightly difficult:
4(10.5%) vs 2(5.1%)
Very difficult: 3(7.9%) vs
2(5.1%)
(p=0.578)
Spanos et
al., 2008,
(13)
RCT,n=70,
1++
Mean Age
(SD):
12(2.4) vs
12(2.2)
Sex:
M=17(49%) vs
18(51%),
F=18(51%) vs
17(49%)
J-Tip jet
injection of 1%
buffered
lidocaine 5 min
before
cannulation
n=35
ELA-Max cream
applied 30 min
before
cannulation
n=35
5-30
min
Primary:
1. Pain of
cannulation in
VAS (mm)
2. Pain of jet
injection in VAS
(mm)
Secondary:
3. Difficulty of
cannulation
(Scale: 1 = very
easy, 2 = easy, 3 =
moderate, 4 =
difficult, 5 = very
difficult.)
4. Initial successful
cannulation
1. Mean(SD), Median Score:
Patient: 17.3(26.7),4 vs
44.6(35.1),39 (p<0.001)
Blinded observer:
21.7(30.9),5 vs 31.9(30.7),35
(p=0.23)
2. Patient:
Mean Score(SD): 3.83(12.1)
No. of pain=0mm: 26(74%)
No. of pain<10mm: 32(91%)
Blinded observer:
Mean Score(SD): 3.57(6.0)
No. of pain=0mm: 23(66%)
No. of pain<10mm: 31(89%)
3. Mean(SD): 2.0(1.1) vs
2.3(1.3) (p=0.27)
4. 22(63) vs19(54)
55
(Frequency, %)
Abbreviations
CAS = Color Analog Scale
CHEOPS=Children’s Hospital of Eastern Ontario Pain Scale
IQR = InterquartileRange
RCT = Randomized Contolled Trial
SD = Standard deviation
VAS = Visual Analog Scale
List of articles
1. Arendts, G., Stevens, M. & Fry, M. (2008). Topical anaesthesia and intravenous cannulation success in paediatric patients: A randomized double-blind trial. British Journal of
Anaesthesia, 100, 521-524. doi:10.1093/bja/aen003
2. Auerbach, M., Tunik, M. & Mojica, M. (2009). A randomized, double-blind controlled study of jet lidocaine compared to jet placebo for pain relief in children undergoing needle
insertion in the emergency department. Academic Emergency Medicine, 16, 388-393. doi:10.1111/j.1553-2712.2009.00401.x
3. Costello, M., Ramundo, M., Christopher, N.C. & Powell, K.R. (2006). Ethyl vinyl chloride vapocoolant spray fails to decrease pain associated with intravenous cannulation in
4. Kim, M.K., Kini, N.M., Troshynski, T.J. & Hennes, H.M. (1999). A randomized clinical trial of dermal anesthesia by iontophoresis for peripheral intravenous catheter placement in
children. Ann Emerg Med, 33(4), 395-359.
5. Luhmann, J., Hurt, S., Shootman, M. & Kennedy, R. (2004). A comparison of buffered lidocaine versus ELA-Max before peripheral intravenous catheter insertions in children.
Pediatrics, 113(3 Pt 1), e217-e220.
6. Mann, T., Taylor, D.McD. & Smit, P.D.V. (2007). Eutectic mixture of local anaesthetics vs nitrous oxide for cannulation of children in the emergency department. Journal of
Pharmacy Practice and Research, 37(4), 281-283. Retrieved September 2, 2011, from
7. Newbury, C. & Herd, D.W. (2009). Amethocaine versus EMLA for successful intravenous cannulation in a children's emergency department: a randomised controlled study. Emerg
56
Med J, 26, 487-491. doi:10.1136/emj.2008.065110
8. Ramsook, C., Kozinetz, C.A. & Moro-Sutherland, D. (2001). Efficacy of ethyl chloride as a local anesthetic for venipuncture and intravenous cannula insertion in a pediatric
emergency department. Pediatric Emergency Care, 17, 341-343. doi:10.1097/00006565-200110000-00005
9. Shavit, I., Hadash, A., Knaani-Levinz, H., Shachor-Meyouhas, Y. & Kassis, I. (2009). Lidocaine-based topical anesthetic with disinfectant (LidoDin) versus EMLA for
venipuncture: A randomized controlled trial. Clinical Journal of Pain, 25, 711-714. doi:10.1097/AJP.0b013e3181a689ec
10. Singer, A.J., Taira, B.R., Chisena, E.N., Gupta, N. & Chipley, J. (2008). Warm lidocaine/tetracaine patch versus placebo before pediatric intravenous cannulation: a randomized
controlled trial. Ann Emerg Med, 52(1), 41-47.
11. Singer, A.J., Weeks, R. & Regev, R. (2006). Laser-assisted anesthesia reduces the pain of venous cannulation in children and adults: a randomized controlled trial. Acad Emerg
Med,13(6), 623-628.
12. Skarbek-Borowska, S., Becker, B.M., Lovgren, K., Bates, A. & Minugh, P.A. (2006). Brief focal ultrasound with topical anesthetic decreases the pain of intravenous placement in
children. Pediatric Emergency Care, 22, 339-345. doi:10.1097/01.pec.0000216566.33747.5b
13. Spanos, S., Booth, R., Koenig, H., Sikes, K., Gracely, E. & Kim, I.K. (2008). Jet injection of 1% buffered lidocaine versus topical ELA-Max for anesthesia before peripheral
intravenous catheterization in children: A randomized controlled trial. Pediatric Emergency Care, 24, 511-515. doi:10.1097/PEC.0b013e31816a8d5b
A
S
StArcaJo
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In
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Appendix 5
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tudy identificrendts, G., Sannulation suournal of Ana
uideline topicn Emergency
ECTION 1:
n a well cond
1 The stuclearly
2 The asgroups
3 An adeused
4 Subjec‘blind’ a
5 The tresimilar
6 The onthe tre
7 All relestanda
8 What pclusterarm of
Methodolo
ethodologyC
cation (IncluStevens, M. &uccess in paeaesthesia, 10
c: The Use oy Departmen
INTERNAL
ducted RCT
udy addressy focused que
ssignment of s is randomis
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cts and invesabout treatm
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nly differenceatment unde
evant outcomard, valid and
percentage ors recruited inf the study dr
ogical Qual
Checklist 2:
ude author, ti& Fry, M. (20ediatric patie00, 521-524.
of Topical Annt
L VALIDITY
T study…
es an appropestion.
f subjects to tsed
ealment met
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control grouof the trial
e between grer investigatio
mes are measd reliable way
of the individunto each trearopped out b
57
lity Appras
Controlled
itle, year of p08). Topical
ents: A randodoi:10.1093
esthesia to R
priate and
treatment
hod is
kept on
ups are
roups is on
sured in a y
uals or atment efore the
ial
Trials
publication, joanaesthesia
omized doub3/bja/aen003
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In this stud
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Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
EMLA Grou
AnGEL Gro
ournal title, pa and intravele-blind trial.
atric IV Cann
dy this criter
ed
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
p=13/93 x 10
up=13/110 x
pages) nous British
nulation Pain
rion is:
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
00% = 13.98
x 100% =
n in
8%
58
study was completed? 11.82%
1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
1.10 Where the study is carried out at more than one site, results are comparable for all sites
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code ++, +, or
+
Comments: Drop-out rate > 10%. No true controls.
S
StAuofinsdo
Gan
In
1.
1.
1.
1.
1.
1.
1.
1.
S I G N
Me
tudy identificuerbach, M.,f jet lidocainesertion in theoi:10.1111/j.1
uideline topicn Emergency
SECTIO
n a well cond
1 The stuclearly
2 The asgroups
3 An adeused
4 Subjec‘blind’ a
5 The tresimilar
6 The onthe trea
7 All relestanda
8 What pclusterarm of study w
ethodologyC
cation (Inclu Tunik, M. &
e compared te emergency553-2712.20
c: The Use oy Departmen
N 1: INTER
ducted RCT
udy addressy focused que
ssignment of s is randomis
equate conce
cts and invesabout treatm
eatment and r at the start o
nly differenceatment unde
evant outcomard, valid and
percentage ors recruited inthe study dr
was complet
Checklist 2:
ude author, tiMojica, M. (
to jet placeboy department009.00401.x
of Topical Annt
RNAL VALID
T study…
es an appropestion.
f subjects to tsed
ealment met
stigators are ment allocatio
control grouof the trial
e between grer investigatio
mes are measd reliable way
of the individunto each trearopped out bed?
59
Controlled
itle, year of p2009). A rano for pain relt. Academic
esthesia to R
DITY
priate and
treatment
hod is
kept on
ups are
roups is on
sured in a y
uals or atment efore the
Trials
publication, jodomized, doief in childreEmergency M
Reduce Pedi
In this stud
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequatelyaddressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
No particip
ournal title, pouble-blind con undergoingMedicine, 16
atric IV Cann
dy this criter
ed
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
d
y
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
pants droppe
pages) ontrolled studg needle 6, 388-393.
nulation Pain
rion is:
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ed out.
dy
n in
60
1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
1.10 Where the study is carried out at more than one site, results are comparable for all sites
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code ++, +, or
++
Comments: Patients in the jet placebo group were less likely to have a recent needle insertion compared to the jet lidocaine and jet control groups (p < 0.05). Jet to cannulation time may be too short to let lidocaine provide effect.
S
StCovach
Gan
In
1.
1.
1.
1.
1.
1.
1.
1.
S I G N
Me
tudy identificostello, M., Rapocoolant shildren. Clinic
uideline topicn Emergency
SECTIO
n a well cond
1 The stuclearly
2 The asgroups
3 An adeused
4 Subjec‘blind’ a
5 The tresimilar
6 The onthe tre
7 All relestanda
8 What pclusterarm of study w
ethodologyC
cation (IncluRamundo, Mpray fails to cal Pediatrics
c: The Use oy Departmen
N 1: INTER
ducted RCT
udy addressy focused que
ssignment of s is randomis
equate conce
cts and invesabout treatm
eatment and r at the start o
nly differenceatment unde
evant outcomard, valid and
percentage ors recruited inf the study drwas complet
itle, year of per, N.C. & Poain associate32. doi:10.11
esthesia to R
DITY
priate and
treatment
hod is
kept on
ups are
roups is on
sured in a y
uals or atment efore the
Trials
publication, joowell, K.R. (2d with intrav77/0009922
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In this stud
Well covere
Adequately addressed
Poorly addre
Well covere
Adequatelyaddressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequatelyaddressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
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(a)ethyl viny
(b)isopropyl
(c)control gr
ournal title, p2006). Ethyl venous cannu
280629101
atric IV Cann
dy this criter
ed
essed
No
No
No
d
y
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
d
y
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
yl chloride gr
alcohol spra
roup= 6/48 x
pages) vinyl chlorideulation in
nulation Pain
rion is:
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
roup= 0%
ay group= 0%
x 100%= 12.5
e
n in
%
5%
62
1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
1.10 Where the study is carried out at more than one site, results are comparable for all sites
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code ++, +, or
+
Comments: Not enough information about randomization was provided. No p-values in comparing demographic data. Drop-out rate of control group > 10%.
S
StKiofch
Gan
In
1.
1.
1.
1.
1.
1.
1.
1.
S I G N
Me
tudy identificm, M.K., Kin
f dermal aneshildren. Ann E
uideline topicn Emergency
SECTIO
n a well cond
1 The stuclearly
2 The asgroups
3 An adeused
4 Subjec‘blind’ a
5 The tresimilar
6 The onthe tre
7 All relestanda
8 What pclusterarm of
ethodologyC
cation (Incluni, N.M., Trossthesia by ioEmerg Med,
c: The Use oy Departmen
N 1: INTER
ducted RCT
udy addressy focused que
ssignment of s is randomis
equate conce
cts and invesabout treatm
eatment and r at the start o
nly differenceatment unde
evant outcomard, valid and
percentage ors recruited inf the study dr
Checklist 2:
ude author, tishynski, T.J. ontophoresis
33(4), 395-3
of Topical Annt
RNAL VALID
T study…
es an appropestion.
f subjects to tsed
ealment met
stigators are ment allocatio
control grouof the trial
e between grer investigatio
mes are measd reliable way
of the individunto each trearopped out b
63
Controlled
itle, year of p& Hennes, Hfor periphera
359
esthesia to R
DITY
priate and
treatment
hod is
kept on
ups are
roups is on
sured in a y
uals or atment efore the
Trials
publication, joH.M. (1999). al intravenou
Reduce Pedi
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Well covere
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Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addressed
Well covere
Adequately addressed
Poorly addressed
Well covere
Adequatelyaddressed
Poorly addre
Well covere
Adequately addressed
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Well covere
Adequatelyaddressed
Poorly addre
Lidocaine gr
Control grou
ournal title, pA randomize
us catheter p
atric IV Cann
dy this criter
ed
essed
No
No
No
ed
essed
No
No
No
d No
No
No
d No
No
No
d
y
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No
No
No
ed
essed
No
No
No
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y
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No
No
No
roup= 1/23 x
up= 2/27x100
pages) ed clinical tri
placement in
nulation Pain
rion is:
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
x100%= 4.35
0%= 7.41%
al
n in
5%
64
study was completed?
1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
1.10 Where the study is carried out at more than one site, results are comparable for all sites
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code ++, +, or
-
Comments: Not enough information about concealment method and blinding were provided. The validity and reliability of the some scales were not mentioned. Only about 10% of eligible participants were able to be captured. No true controls. Sample size too small.
percentage ors recruited inf the study drwas complet
Checklist 2:
ude author, tiootman, M. &
before perip17-e220
of Topical Annt
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T study…
es an appropestion.
f subjects to tsed
ealment met
stigators are ment allocatio
control grouof the trial
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mes are measd reliable way
of the individunto each trearopped out bed?
65
Controlled
itle, year of p& Kennedy, Rpheral intrave
esthesia to R
DITY
priate and
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hod is
kept on
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roups is on
sured in a y
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Trials
publication, joR. (2004). A cenous cathet
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Poorly addre
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Adequately addressed
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Well covere
Adequately addressed
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Well covere
Adequatelyaddressed
Poorly addre
Well covere
Adequatelyaddressed
Poorly addre
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Adequately addressed
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Adequately addressed
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No particip
ournal title, pcomparison ter insertions
atric IV Cann
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No
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No
No
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No
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n in
66
1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
1.10 Where the study is carried out at more than one site, results are comparable for all sites
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code ++, +, or
++
Comments: An observer who did not know the purpose of study was used, making the investigation somehow blinded. Not enough information of intention to treat analysis. No p-values were provided for demographic data except prior experience of IV cannulation. No true controls.
cation (Incluor, D.McD. &for cannulatioactice and Revid.com/ovid
c: The Use oy Departmen
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udy addressefocused que
signment of is randomise
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Well covered
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ournal title, pe of local ana
artment. JourSeptember 2,=emed8&NE
atric IV Cann
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68
arm of the study dropped out before the study was completed?
1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
1.10 Where the study is carried out at more than one site, results are comparable for all sites
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code ++, +, or
-
Comments: Only abstract could be achieved. Much information was not mentioned in detailed. The study was not applicable to be blinded.
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StNecaM
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1.
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1.
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tudy identificewbury, C. &annulation in
Med J, 26, 487
uideline topicn Emergency
SECTIO
n a well cond
1 The stuclearly
2 The asgroups
3 An adeused
4 Subjec‘blind’ a
5 The tresimilar
6 The onthe tre
7 All relestanda
8 What pclusterarm of study w
ethodologyC
cation (Inclu& Herd, D.W.
a children's 7-491. doi:10
c: The Use oy Departmen
N 1: INTER
ducted RCT
udy addressy focused que
ssignment of s is randomis
equate conce
cts and invesabout treatm
eatment and r at the start o
nly differenceatment unde
evant outcomard, valid and
percentage ors recruited inf the study drwas complet
Checklist 2:
ude author, ti(2009). Ameemergency
0.1136/emj.2
of Topical Annt
RNAL VALID
T study…
es an appropestion.
f subjects to tsed
ealment met
stigators are ment allocatio
control grouof the trial
e between grer investigatio
mes are measd reliable way
of the individunto each trearopped out bed?
69
Controlled
itle, year of pethocaine vedepartment:
2008.065110
esthesia to R
DITY
priate and
treatment
hod is
kept on
ups are
roups is on
sured in a y
uals or atment efore the
Trials
publication, joersus EMLA f
a randomise
Reduce Pedi
In this stud
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequatelyaddressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Amethocain7.67%
EMLA group
ournal title, pfor successfued controlled
atric IV Cann
dy this criter
ed
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
d
y
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
ne group= 28
p= 29/371 x1
pages) ul intravenoud study. Eme
nulation Pain
rion is:
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
8/365 x100%
100%= 7.82%
us rg
n in
=
%
70
1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
1.10 Where the study is carried out at more than one site, results are comparable for all sites
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code ++, +, or
++
Comments: Drop-out rate was not systematically reported, <10%. 2 scales were used for different age groups. Some of the results (95% CI) were shown on graphs only. No true controls.
S
StRalocemdo
Gan
In
1.
1.
1.
1.
1.
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1.
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tudy identificamsook, C., cal anesthetmergency deoi:10.1097/00
uideline topicn Emergency
SECTIO
n a well cond
1 The stuclearly
2 The asgroups
3 An adeused
4 Subjec‘blind’ a
5 The tresimilar
6 The onthe trea
7 All relestanda
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ethodologyC
cation (IncluKozinetz, C.ic for venipu
epartment. Pe0006565-200
c: The Use oy Departmen
N 1: INTER
ducted RCT
udy addressy focused que
ssignment of s is randomis
equate conce
cts and invesabout treatm
eatment and r at the start o
nly differenceatment unde
evant outcomard, valid and
percentage ors recruited inthe study dr
was complet
Checklist 2:
ude author, ti.A. & Moro-Sncture and inediatric Eme0110000-000
1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
1.10 Where the study is carried out at more than one site, results are comparable for all sites
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code ++, +, or
+
Comment: Not enough information of concealment method was provided. Writing style should be logical and systematic. Reporting p-value should be in numeric form instead of NS. No true controls.
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1.
1.
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tudy identifichavit, I., Haddocaine-bas
enipuncture: oi:10.1097/AJ
uideline topicn Emergency
SECTIO
n a well cond
1 The stuclearly
2 The asgroups
3 An adeused
4 Subjec‘blind’ a
5 The tresimilar
6 The onthe trea
7 All relestanda
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ethodologyC
cation (Includash, A., Knaed topical anA randomizeJP.0b013e31
1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
1.10 Where the study is carried out at more than one site, results are comparable for all sites
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code ++, +, or
+
Comments: Sample size too small. Drop-out rate ~10%.
S
StSiofM
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1.
1.
1.
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tudy identificnger, A.J., W
f venous canMed,13(6), 62
uideline topicn Emergency
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n a well cond
1 The stuclearly
2 The asgroups
3 An adeused
4 Subjec‘blind’ a
5 The tresimilar
6 The onthe tre
7 All relestanda
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ethodologyC
cation (IncluWeeks, R. & nulation in c3-628.
c: The Use oy Departmen
N 1: INTER
ducted RCT
udy addressy focused que
ssignment of s is randomis
equate conce
cts and invesabout treatm
eatment and r at the start o
nly differenceatment unde
evant outcomard, valid and
percentage ors recruited inf the study drwas complet
Checklist 2:
ude author, tiRegev, R. (2hildren and a
of Topical Annt
RNAL VALID
T study…
es an appropestion.
f subjects to tsed
ealment met
stigators are ment allocatio
control grouof the trial
e between grer investigatio
mes are measd reliable way
of the individunto each trearopped out bed?
77
Controlled
itle, year of p2006). Laser-adults: a ran
esthesia to R
DITY
priate and
treatment
hod is
kept on
ups are
roups is on
sured in a y
uals or atment efore the
Trials
publication, jo-assisted anedomized con
Reduce Pedi
In this stud
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequatelyaddressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
No particip
ournal title, pesthesia redntrolled trial.
atric IV Cann
dy this criter
ed
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
d
y
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
pants droppe
pages) uces the paiAcad Emerg
nulation Pain
rion is:
ot addressed
ot reported
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ot addressed
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ot applicable
ot addressed
ot reported
ot applicable
ot addressed
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ot applicable
ot addressed
ot reported
ot applicable
ed out.
n g
n in
78
1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
1.10 Where the study is carried out at more than one site, results are comparable for all sites
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code ++, +, or
+
Comments: Sample size too small. Although mean age of patient is high (over 18yrs), stratified randomization was used and data of pediatric subjects could be indepedently analyzed.
S
StSkfochdo
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In
1.
1.
1.
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1.
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tudy identifickarbek-Borowcal ultrasoun
hildren. Pedoi:10.1097/01
uideline topicn Emergency
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2 The asgroups
3 An adeused
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6 The onthe trea
7 All relestanda
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ethodologyC
cation (Incluwska, S., Bend with topicadiatric Emerg1.pec.00002
c: The Use oy Departmen
N 1: INTER
ducted RCT
udy addressy focused que
ssignment of s is randomis
equate conce
cts and invesabout treatm
eatment and r at the start o
nly differenceatment unde
evant outcomard, valid and
percentage ors recruited inthe study dr
was complet
Checklist 2:
ude author, tiecker, B.M., Lal anestheticgency Care, 16566.33747
of Topical Annt
RNAL VALID
T study…
es an appropestion.
f subjects to tsed
ealment met
stigators are ment allocatio
control grouof the trial
e between grer investigatio
mes are measd reliable way
of the individunto each trearopped out bed?
79
Controlled
itle, year of pLovgren, K., c decreases t22, 339-3457.5b
esthesia to R
DITY
priate and
treatment
hod is
kept on
ups are
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sured in a y
uals or atment efore the
Trials
publication, joBates, A. & Mthe pain of in.
Reduce Pedi
In this stud
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Well covere
Adequately addressed
Poorly addre
Treatment g
Placebo gro
ournal title, pMinugh, P.A.ntravenous p
atric IV Cann
dy this criter
ed
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
ed
essed
No
No
No
group =3/41 x
oup= 2/41 x1
pages) (2006). Brie
placement in
nulation Pain
rion is:
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
ot addressed
ot reported
ot applicable
x100%= 7.32
00%= 4.88%
ef
n in
2%
%
80
1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
1.10 Where the study is carried out at more than one site, results are comparable for all sites
Well covered
Adequately addressed
Poorly addressed
Not addressed
Not reported
Not applicable
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code ++, +, or
++
Comments: Sample size relatively small. Not enough demographic data was provided. No sham ultrasound device or true contol.
Size of Cannula: □20GA □22GA □24GA □Others:_______
Location of Cannulation: □Antecubital □Hand □Others:__________
Pain Score:____________/10
Adverse Events: □None □Erythema □Edema □Pruritus
□Others:__________
Disposal: □Home □EMW □Admission
P.T.O. for FLACC Scale
106
FLACC Scale
Please return to collection box in nursing station after completion.
107
Appendix 17 Evaluation Table
Outcomes Tools Frequency
(Wk)
Objectives Method of
Analysis
Basis of Change
Pain NTWC Pain Assessment Tool
(units)
26 To determine if pain is reduced compared to that of
non-intervention period
2-tailed
t-test*
Reduce 1 unit
Admission
rate
Patient record (%) 26 To determine if admission rate reduced compared to
that of same period of last year
2-tailed t-test Reduce 3%
Length of
stay
Patient record (patient-day) 26 To determine if length of hospital stay reduced
compared to that of same period of last year
2-tailed t-test Reduce 1
patient-day
Staff
satisfaction
5-point Likert scale 13, 26 To estimate the staff satisfaction during the
innovation
95% CI Mean score >3
Utilization
rate
Patient Record (%) 13, 26 To estimate the utilization rate 95% CI >70%
Cost Account record, Compensation
hour record (HKD)
26 To evaluate the cost of innovation N/A Around
HK$44405.1
*Minimum significant effect: 1 unit, SD: 3 unit, Effect size d: 0.9, Power: 0.8, Alpha: 0.05
Sample size estimated: 73
Estimated number of clients weekly: 1565/52 = 30
Expected time to achieve 73 clients: 3 weeks
108
Appendix 18
Satisfactory Survey for Healthcare Providers- The Use of Topical Anesthesia to Reduce Pediatric Intravenous Cannulation Pain in an Emergency Department Please circle your answer.
Strongly
Disagree
Disagree No
Comment
Agree Strongly
Agree
1. I think this innovation can reduce pediatric IV
cannulation pain. 1 2 3 4 5
2. I think this innovation do not place a burden to
healthcare providers. 1 2 3 4 5
3. I think I am competent in doing this anesthesia
procedure. 1 2 3 4 5
4. I feel comfortable in doing this anesthesia
procedure. 1 2 3 4 5
5. I support this innovation. 1 2 3 4 5
Please return to collection box in nursing station after completion.