The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 2

Conditions: Needle Phobia; Pain

Treatments: Drug: EMLA Cream; Combination Product: Synera Patch

Study type: Interventional

Funder types: Other

Identifiers

NCT00530803

07-06-159

Details and patient eligibility

About

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.

Full description

Venipunctures are common and necessary components of pediatric health care. Unfortunately, many children have "needle phobia" and even a simple procedure, such as a venipuncture, can cause significant stress and anxiety to the patient and the parents involved. Studies have shown that needles are the worst part of hospital/healthcare related visits for children.

The Synera patch uses a controlled heating system to transcutaneously deliver a lidocaine/tetracaine mixture for analgesic effect. No published studies compare the efficacy of the Synera patch with other topical anesthetics in children. The objective of this study is to compare the efficacy of the Synera patch applied for 20 minutes with the efficacy of EMLA Cream applied for 60 minutes in reducing pain associated with venipunctures in children.

Patients, 4-12 years old children requiring venipunctures in clinics, were randomized to receive Synera for 20 minutes or EMLA for 60 minutes. A blinded observer recorded pain scores using a numerical rating scale (NRS). Child and parent assessed pain with the Wong-Baker FACES Scale and the NRS, respectively. The primary outcome was the number of subjects reporting "no pain". Secondary outcomes were parent and observer measures of the child's pain and the presence of skin reactions.

Enrollment: 100 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

EMLA Cream

Active Comparator group

Description:

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.

Treatment:

Drug: EMLA Cream

Synera Patch

Active Comparator group

Description:

Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.

Treatment:

Combination Product: Synera Patch