Trial Outcomes & Findings for Emla-Cream as Pain Relief During Pneumococcal Vaccination (NCT NCT01802086)
NCT ID: NCT01802086
Last Updated: 2025-10-23
Results Overview
The effect of Emla cream on pain perception during pneumococcal vaccination was measured by FLACC scale that includes five items; Face, Legs, Activity, Cry, Consolability. FLACC scale i a qualitative behavioural scale used for pain assesment and has been validated for use in infants aged 2 months to 7 years. Each item (Face, Legs, Activity, Cry and Consolability) can give 0,1 or 2 points according to the description included in the FLACC scale. The total summarised pain score can range between 0-10 points. A higher pain-score indicate more pain, which means a worse outcome. FLACC scale was measured before and after vaccination and compared between the groups (Emla-cream vs Miniderm cream).
COMPLETED
NA
72 participants
Before vaccination and after vaccination, up to three minutes.
2025-10-23
Participant Flow
Participant milestones
| Measure |
Emla-cream
Dose: 1 g Emla-cream, 1 hour.
Emla-cream: Topical anaesthetic
36 infants received Emla (intervention)
|
Miniderm Cream
Dose: 1 g Miniderm cream, 1 hour.
Miniderm cream: Topical
34 infants received Miniderm Cream (placebo).
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
36
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Emla-Cream as Pain Relief During Pneumococcal Vaccination
Baseline characteristics by cohort
| Measure |
Emla-cream
n=36 Participants
Dose: 1 g Emla-cream, 1 hour.
Emla-cream: Topical anaesthetic
|
Miniderm Cream
n=36 Participants
Dose: 1 g Miniderm-cream, 1 hour.
Miniderm cream: Topical
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
36 Participants
n=39 Participants
|
36 Participants
n=41 Participants
|
72 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
32 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Before vaccination and after vaccination, up to three minutes.The effect of Emla cream on pain perception during pneumococcal vaccination was measured by FLACC scale that includes five items; Face, Legs, Activity, Cry, Consolability. FLACC scale i a qualitative behavioural scale used for pain assesment and has been validated for use in infants aged 2 months to 7 years. Each item (Face, Legs, Activity, Cry and Consolability) can give 0,1 or 2 points according to the description included in the FLACC scale. The total summarised pain score can range between 0-10 points. A higher pain-score indicate more pain, which means a worse outcome. FLACC scale was measured before and after vaccination and compared between the groups (Emla-cream vs Miniderm cream).
Outcome measures
| Measure |
Emla-cream
n=36 Participants
Dose: 1 g Emla-cream, 1 hour.
Emla-cream: Topical anaesthetic
|
Miniderm Cream
n=36 Participants
Dose: 1 g Miniderm-cream, 1 hour.
Miniderm cream: Topical
|
|---|---|---|
|
Measuring the Effect of Emla Cream on Pain Perception During Pneumococcal Vaccination Measured With Five Items; Face, Legs, Activity, Cry, Consolability (FLACC Scale).
FLACC score before vaccination
|
0 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 4.5
|
|
Measuring the Effect of Emla Cream on Pain Perception During Pneumococcal Vaccination Measured With Five Items; Face, Legs, Activity, Cry, Consolability (FLACC Scale).
FLACC score after vaccination
|
7 score on a scale
Interval 6.0 to 9.0
|
9 score on a scale
Interval 7.0 to 9.0
|
SECONDARY outcome
Timeframe: Before vaccination and after vaccination, up to three minutes.Population: We analysed for how long time it takes until the baby starts to cry and for how long time the baby is crying.
Latency time to cry (scored in seconds): * how long does it takes until the baby starts to cry after vaccination was performed (the longer it takes until the baby starts to cry indicate less pain, a better outcome). Min- or maximum values is not applicable. Total crying time (scored in seconds): * how long time is the baby crying after vaccination was performed (the longer time the baby is crying indicate more pain, a worse outcome). Min- or maximum values is not applicable.
Outcome measures
| Measure |
Emla-cream
n=36 Participants
Dose: 1 g Emla-cream, 1 hour.
Emla-cream: Topical anaesthetic
|
Miniderm Cream
n=36 Participants
Dose: 1 g Miniderm-cream, 1 hour.
Miniderm cream: Topical
|
|---|---|---|
|
Pain Perception Measured With Latency Time to Cry and Total Crying Time.
Latency time to cry (seconds)
|
2.77 Time in seconds
Standard Deviation 0.80
|
2.05 Time in seconds
Standard Deviation 0.978
|
|
Pain Perception Measured With Latency Time to Cry and Total Crying Time.
Total crying time (seconds)
|
78.74 Time in seconds
Standard Deviation 45.866
|
100.44 Time in seconds
Standard Deviation 73.307
|
SECONDARY outcome
Timeframe: Before vaccination and after vaccination, up to three minutesPopulation: We analysed the babies heart rate (beats per minute) before and after vaccination.
Heart rate before and after vaccination (beats per minute), higher values indicate more pain, a worse outcome. Min and max values are not applicable.
Outcome measures
| Measure |
Emla-cream
n=36 Participants
Dose: 1 g Emla-cream, 1 hour.
Emla-cream: Topical anaesthetic
|
Miniderm Cream
n=36 Participants
Dose: 1 g Miniderm-cream, 1 hour.
Miniderm cream: Topical
|
|---|---|---|
|
Heart Rate (Beats Per Minute) Before and After Vaccination
Beats per minute before vaccination
|
148.31 beats per minute
Standard Deviation 17.33
|
147.93 beats per minute
Standard Deviation 17.95
|
|
Heart Rate (Beats Per Minute) Before and After Vaccination
Beats per minute after vaccination
|
159.59 beats per minute
Standard Deviation 15.53
|
160.46 beats per minute
Standard Deviation 17.36
|
SECONDARY outcome
Timeframe: Before vaccination and after vaccination, up to three minutesPopulation: We analysed the babies oxygen saturation before and after vaccination.
Oxygen saturation before and after vaccination (0-100%), a lower value indicate more pain, a worse outcome
Outcome measures
| Measure |
Emla-cream
n=36 Participants
Dose: 1 g Emla-cream, 1 hour.
Emla-cream: Topical anaesthetic
|
Miniderm Cream
n=36 Participants
Dose: 1 g Miniderm-cream, 1 hour.
Miniderm cream: Topical
|
|---|---|---|
|
Saturation Before and After Vaccination.
Before vaccination
|
99.59 percentage of oxygen saturation
Standard Deviation 0.82
|
99.78 percentage of oxygen saturation
Standard Deviation 0.43
|
|
Saturation Before and After Vaccination.
After vaccination
|
98.86 percentage of oxygen saturation
Standard Deviation 1.22
|
98.76 percentage of oxygen saturation
Standard Deviation 2.06
|
Adverse Events
Emla-cream
Miniderm Cream
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place