Trial Outcomes & Findings for Topical Amethocaine Gel for Intramuscular Injection in Term Neonates (NCT NCT00267111)
NCT ID: NCT00267111
Last Updated: 2024-07-30
Results Overview
The presence or absence of 3 facial actions (brow bulge, eyes squeeze and deepening of the nasolabial furrow) were scored in 2 second intervals for the first 20 seconds (or less if the phase lasted \< 20 seconds) of each procedure phase from the videotapes by a trained research assistant. The data were then collapsed for each facial action into the percentage of time the infant expressed the action. An overall pain score was computed by summing the percentage scores for the three facial actions and then dividing by three. The score ranged from 0% to 100% with higher values suggesting more pain.
COMPLETED
PHASE2
110 participants
For the purpose of analysis IM injection procedure was divided into 4 phases: baseline , cleansing, injection and recovery phases.. For each phase facial actions were scored for the first 20 seconds or less if the phase lasted < 20 seconds.
2024-07-30
Participant Flow
The study was conducted between July 2003 and December 2004 in the Labour and Delivery Unit of Mount Sinai Hospital.
Participant milestones
| Measure |
Amethocaine Gel 4% Group
1 g of topical amethocaine gel 4%.
|
Placebo Group
1 g Eucerin plus was used as a placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
55
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Amethocaine Gel for Intramuscular Injection in Term Neonates
Baseline characteristics by cohort
| Measure |
Amethocaine Gel 4% Group
n=55 Participants
1 g of topical amethocaine gel 4%.
|
Placebo Group
n=55 Participants
1 g Eucerin plus was used as a placebo.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
55 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
39.2 years
STANDARD_DEVIATION 1.0 • n=7 Participants
|
39.25 years
STANDARD_DEVIATION 1.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
55 participants
n=5 Participants
|
55 participants
n=7 Participants
|
110 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: For the purpose of analysis IM injection procedure was divided into 4 phases: baseline , cleansing, injection and recovery phases.. For each phase facial actions were scored for the first 20 seconds or less if the phase lasted < 20 seconds.Population: Intention to treat analysis
The presence or absence of 3 facial actions (brow bulge, eyes squeeze and deepening of the nasolabial furrow) were scored in 2 second intervals for the first 20 seconds (or less if the phase lasted \< 20 seconds) of each procedure phase from the videotapes by a trained research assistant. The data were then collapsed for each facial action into the percentage of time the infant expressed the action. An overall pain score was computed by summing the percentage scores for the three facial actions and then dividing by three. The score ranged from 0% to 100% with higher values suggesting more pain.
Outcome measures
| Measure |
1 g Amethocaine Gel 4%
n=54 Participants
1 g Amethocaine gel 4% was used as the active drug
|
Placebo Group
n=53 Participants
1 g Eucerin plus was used as a placebo
|
|---|---|---|
|
Pain Scores Assessed by Neonatal Facial Action
Baseline
|
14 Percentage of time
Standard Deviation 26
|
18 Percentage of time
Standard Deviation 28
|
|
Pain Scores Assessed by Neonatal Facial Action
Cleaning
|
30 Percentage of time
Standard Deviation 39
|
44 Percentage of time
Standard Deviation 42
|
|
Pain Scores Assessed by Neonatal Facial Action
Injection
|
70 Percentage of time
Standard Deviation 32
|
75 Percentage of time
Standard Deviation 34
|
|
Pain Scores Assessed by Neonatal Facial Action
Recovery
|
79 Percentage of time
Standard Deviation 24
|
76 Percentage of time
Standard Deviation 28
|
SECONDARY outcome
Timeframe: During the entire procedurePopulation: Intention to treat analysis
Parents and nurses were asked to assess the infant's pain response during the procedure using Visual analogue scale (VAS) on an unmarked horizontal 10 cm continuous line where 0="no pain" on the left side and 10="worst possible pain" on the right side. Parents and nurses were trained to use the VAS prior to the IM injection.
Outcome measures
| Measure |
1 g Amethocaine Gel 4%
n=54 Participants
1 g Amethocaine gel 4% was used as the active drug
|
Placebo Group
n=55 Participants
1 g Eucerin plus was used as a placebo
|
|---|---|---|
|
Visual Analogue Scale
Parents VAS rating
|
4.6 Cms
Standard Deviation 2.3
|
4.6 Cms
Standard Deviation 2.4
|
|
Visual Analogue Scale
Nurses VAS rating
|
5.0 Cms
Standard Deviation 2.1
|
4.9 Cms
Standard Deviation 2.3
|
Adverse Events
Amethocaine Gel 4% Group
Placebo Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amethocaine Gel 4% Group
n=54 participants at risk
1 g of topical amethocaine gel 4%.
|
Placebo Group
n=53 participants at risk
1 g Eucerin plus was used as a placebo.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Local erythema
|
13.0%
7/54 • Number of events 54
|
7.5%
4/53 • Number of events 53
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place