Phase 2
Completed N=100
The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children
Postoperative Pain · Needle Phobia
Source: ClinicalTrials.gov NCT00530803 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. — 42; 38; 6; 8 Participants
Summary
This study compares the efficacy of the Synera patch with Eutectic Mixture of Local Anesthetics (EMLA) as a topical anesthetic for venipuncture in pediatric patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. |
42; 38; 6; 8; 2; 3 | — |
| SECONDARY Parent Rating of Child's Pain Using a 6-point NRS |
42; 41; 6; 5; 1; 1 | — |
| SECONDARY Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS |
41; 37; 6; 6; 2; 5 | — |
| SECONDARY Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS |
32; 25; 14; 12; 2; 9 | — |
| SECONDARY Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS |
45; 45; 3; 4; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Children in outpatient clinics requiring venipuncture for medical care
- Ages 4-12 years old
- The ability to demonstrate proper understanding of the Wong-Baker FACES Pain Ranking Scale
- Parents of enrolled children need to be present during the procedure and be willing to rate their child's pain
Exclusion Criteria
- Damaged or inflamed skin at the designated application site
- Known sensitivity to components of Synera or EMLA (lidocaine, tetracaine, or local anesthetics of the amide or ester type, Para Aminobenzoic (PABA) derivatives)
- Contraindications to SYnera or EMLA use (Severe hepatic disease, history of drug-induced methemoglobinemia, taking Class 1 antiarrhythmics)
- Use of analgesics during the past 24 hours
Data sourced from ClinicalTrials.gov (NCT00530803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.