Trial Outcomes & Findings for The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children (NCT NCT00530803)
NCT ID: NCT00530803
Last Updated: 2018-08-31
Results Overview
Participants were asked to report their level of pain using a 6-point Wong-Baker FACES Pain Rating Scale ranging from 0, "no pain," to 5, "the most pain you can have." The Wong-Baker FACES Pain Rating Scale is a validated tool for measuring pain in patients as young as 3 years old. A FACES pain score less than or equal to 2 is considered no pain to mild pain, and is clinically acceptable. Studies have shown average FACES pain scores for children receiving vascular access with placebo to be 2.2 to 3.5.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
immediately after completion of venipuncture
Results posted on
2018-08-31
Participant Flow
Children, ages 4 - 12 , who had outpatient clinic visits between June 2007 and August 2008 at an urban, tertiary care hospital and required venipunctures for medical care were recruited for this study.
Participant milestones
| Measure |
EMLA Cream
Participants will have a dose of EMLA Cream applied to the venipuncture site 1 hour before the procedure. Dosage based on age and weight: 4-6 years old and heavier than 10kg will receive 10g of EMLA; 7-12 years old and more than 20kg will receive 20g of EMLA.
EMLA Cream: 60 minutes x1
|
Synera Patch
Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.
Synera Patch: 20 minutes x1
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children
Baseline characteristics by cohort
| Measure |
EMLA Cream
n=50 Participants
Participants will have a dose of EMLA Cream applied to the venipuncture site 1 hour before the procedure. Dosage based on age and weight: 4-6 years old and heavier than 10kg will receive 10g of EMLA; 7-12 years old and more than 20kg will receive 20g of EMLA.
EMLA Cream: 60 minutes x1
|
Synera Patch
n=50 Participants
Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.
Synera Patch: 20 minutes x1
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.7 Years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
8.9 Years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
8.8 Years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Number of Participants with Prior Venipunctures
Less than10 venipunctures
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Number of Participants with Prior Venipunctures
More than 10 venipunctures
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Number of participants with history of topical anesthetics use
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: immediately after completion of venipunctureParticipants were asked to report their level of pain using a 6-point Wong-Baker FACES Pain Rating Scale ranging from 0, "no pain," to 5, "the most pain you can have." The Wong-Baker FACES Pain Rating Scale is a validated tool for measuring pain in patients as young as 3 years old. A FACES pain score less than or equal to 2 is considered no pain to mild pain, and is clinically acceptable. Studies have shown average FACES pain scores for children receiving vascular access with placebo to be 2.2 to 3.5.
Outcome measures
| Measure |
EMLA Cream
n=50 Participants
Participants will have a dose of EMLA Cream applied to the venipuncture site 1 hour before the procedure. Dosage based on age and weight: 4-6 years old and heavier than 10kg will receive 10g of EMLA; 7-12 years old and more than 20kg will receive 20g of EMLA.
EMLA Cream: 60 minutes x1
|
Synera Patch
n=50 Participants
Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.
Synera Patch: 20 minutes x1
|
|---|---|---|
|
Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale.
Participants with FACES Score = 0 (No pain)
|
42 Participants
|
38 Participants
|
|
Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale.
Participants with FACES Score = 1
|
6 Participants
|
8 Participants
|
|
Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale.
Participants with FACES Score = 2
|
2 Participants
|
3 Participants
|
|
Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale.
Participants with FACES Score = 3
|
0 Participants
|
1 Participants
|
|
Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale.
Participants with FACES Score = 4
|
0 Participants
|
0 Participants
|
|
Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale.
Participants with FACES Score = 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: immediately after venipuncture is completedPopulation: Number of parent assessment for each pain level on the 6-point NRS. Each participant had only one parental assessment.
The Numerical Rating Scale (NRS) is a 6-point rating scale where 0= no pain and 5 = worst pain. Parents reported their own subjective evaluation of participants pain level. Each participant had only one parental assessment. Total number of parental assessment for each pain level on the 6-point NRS is reported as total number of participants experiencing that pain level.
Outcome measures
| Measure |
EMLA Cream
n=50 Participants
Participants will have a dose of EMLA Cream applied to the venipuncture site 1 hour before the procedure. Dosage based on age and weight: 4-6 years old and heavier than 10kg will receive 10g of EMLA; 7-12 years old and more than 20kg will receive 20g of EMLA.
EMLA Cream: 60 minutes x1
|
Synera Patch
n=50 Participants
Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.
Synera Patch: 20 minutes x1
|
|---|---|---|
|
Parent Rating of Child's Pain Using a 6-point NRS
number of participants with NRS=0 (no pain)
|
42 Participants
|
41 Participants
|
|
Parent Rating of Child's Pain Using a 6-point NRS
number of participants with NRS=1
|
6 Participants
|
5 Participants
|
|
Parent Rating of Child's Pain Using a 6-point NRS
number of participants with NRS=2
|
1 Participants
|
1 Participants
|
|
Parent Rating of Child's Pain Using a 6-point NRS
number of participants with NRS=3
|
1 Participants
|
2 Participants
|
|
Parent Rating of Child's Pain Using a 6-point NRS
number of participants with NRS=4
|
0 Participants
|
0 Participants
|
|
Parent Rating of Child's Pain Using a 6-point NRS
number of participants with NRS=5
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: before venipunctureThe NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain experienced by the participants at tourniquet placement. Total number of participants subjectively evaluated as experiencing each pain level is reported.
Outcome measures
| Measure |
EMLA Cream
n=50 Participants
Participants will have a dose of EMLA Cream applied to the venipuncture site 1 hour before the procedure. Dosage based on age and weight: 4-6 years old and heavier than 10kg will receive 10g of EMLA; 7-12 years old and more than 20kg will receive 20g of EMLA.
EMLA Cream: 60 minutes x1
|
Synera Patch
n=50 Participants
Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.
Synera Patch: 20 minutes x1
|
|---|---|---|
|
Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS
Participants evaluated at NRS = 0 (No pain)
|
41 Participants
|
37 Participants
|
|
Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS
Participants evaluated at NRS = 1
|
6 Participants
|
6 Participants
|
|
Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS
Participants evaluated at NRS = 2
|
2 Participants
|
5 Participants
|
|
Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS
Participants evaluated at NRS = 3
|
1 Participants
|
1 Participants
|
|
Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS
Participants evaluated at NRS = 4
|
0 Participants
|
1 Participants
|
|
Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS
Participants evaluated at NRS = 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: during needle insertionThe NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain experienced by the participants at needle insertion. Total number of participants subjectively evaluated as experiencing each pain level is reported.
Outcome measures
| Measure |
EMLA Cream
n=50 Participants
Participants will have a dose of EMLA Cream applied to the venipuncture site 1 hour before the procedure. Dosage based on age and weight: 4-6 years old and heavier than 10kg will receive 10g of EMLA; 7-12 years old and more than 20kg will receive 20g of EMLA.
EMLA Cream: 60 minutes x1
|
Synera Patch
n=50 Participants
Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.
Synera Patch: 20 minutes x1
|
|---|---|---|
|
Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS
Participants evaluated at NRS = 0 (No pain)
|
32 Participants
|
25 Participants
|
|
Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS
Participants evaluated at NRS = 1
|
14 Participants
|
12 Participants
|
|
Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS
Participants evaluated at NRS = 2
|
2 Participants
|
9 Participants
|
|
Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS
Participants evaluated at NRS = 3
|
2 Participants
|
2 Participants
|
|
Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS
Participants evaluated at NRS = 4
|
0 Participants
|
2 Participants
|
|
Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS
Participants evaluated at NRS = 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 minutes post venipunctureThe NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain participants were experiencing 5 minutes after the venipuncture was completed. Total number of participants subjectively evaluated as experiencing each pain level is reported.
Outcome measures
| Measure |
EMLA Cream
n=50 Participants
Participants will have a dose of EMLA Cream applied to the venipuncture site 1 hour before the procedure. Dosage based on age and weight: 4-6 years old and heavier than 10kg will receive 10g of EMLA; 7-12 years old and more than 20kg will receive 20g of EMLA.
EMLA Cream: 60 minutes x1
|
Synera Patch
n=50 Participants
Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.
Synera Patch: 20 minutes x1
|
|---|---|---|
|
Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS
Participants evaluated at NRS = 0 (No pain)
|
45 Participants
|
45 Participants
|
|
Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS
Participants evaluated at NRS = 1
|
3 Participants
|
4 Participants
|
|
Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS
Participants evaluated at NRS = 2
|
1 Participants
|
1 Participants
|
|
Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS
Participants evaluated at NRS = 3
|
1 Participants
|
0 Participants
|
|
Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS
Participants evaluated at NRS = 4
|
0 Participants
|
0 Participants
|
|
Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS
Participants evaluated at NRS = 5
|
0 Participants
|
0 Participants
|
Adverse Events
EMLA Cream
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Synera Patch
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EMLA Cream
n=50 participants at risk
Participants will have a dose of EMLA Cream applied to the venipuncture site 1 hour before the procedure. Dosage based on age and weight: 4-6 years old and heavier than 10kg will receive 10g of EMLA; 7-12 years old and more than 20kg will receive 20g of EMLA.
EMLA Cream: 60 minutes x1
|
Synera Patch
n=50 participants at risk
Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.
Synera Patch: 20 minutes x1
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.0%
6/50 • Investigators monitored for adverse events during procedure and up to 20 minutes after removal of topical anesthetic.
Skin reactions actively watched for during procedure. No major adverse outcomes, minor site reactions resolved shortly after removal of EMLA.
|
14.0%
7/50 • Investigators monitored for adverse events during procedure and up to 20 minutes after removal of topical anesthetic.
Skin reactions actively watched for during procedure. No major adverse outcomes, minor site reactions resolved shortly after removal of EMLA.
|
|
Skin and subcutaneous tissue disorders
Pruitis
|
2.0%
1/50 • Investigators monitored for adverse events during procedure and up to 20 minutes after removal of topical anesthetic.
Skin reactions actively watched for during procedure. No major adverse outcomes, minor site reactions resolved shortly after removal of EMLA.
|
0.00%
0/50 • Investigators monitored for adverse events during procedure and up to 20 minutes after removal of topical anesthetic.
Skin reactions actively watched for during procedure. No major adverse outcomes, minor site reactions resolved shortly after removal of EMLA.
|
|
Skin and subcutaneous tissue disorders
pallor
|
40.0%
20/50 • Investigators monitored for adverse events during procedure and up to 20 minutes after removal of topical anesthetic.
Skin reactions actively watched for during procedure. No major adverse outcomes, minor site reactions resolved shortly after removal of EMLA.
|
6.0%
3/50 • Investigators monitored for adverse events during procedure and up to 20 minutes after removal of topical anesthetic.
Skin reactions actively watched for during procedure. No major adverse outcomes, minor site reactions resolved shortly after removal of EMLA.
|
|
Skin and subcutaneous tissue disorders
Edema
|
0.00%
0/50 • Investigators monitored for adverse events during procedure and up to 20 minutes after removal of topical anesthetic.
Skin reactions actively watched for during procedure. No major adverse outcomes, minor site reactions resolved shortly after removal of EMLA.
|
0.00%
0/50 • Investigators monitored for adverse events during procedure and up to 20 minutes after removal of topical anesthetic.
Skin reactions actively watched for during procedure. No major adverse outcomes, minor site reactions resolved shortly after removal of EMLA.
|
Additional Information
Associate Professor, Dept of Pediatrics
Montefiore Medical Center
Phone: 718-741-2460
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place