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

Pain Clinical Trial

Official title:
The Efficacy of the Eutectic Mixture of Local Anesthetics (EMLA) Cream Versus the Synera Patch for Pain Reduction During Venipuncture in Children

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00530803
Study type Interventional
Source Montefiore Medical Center
Contact
Status Completed
Phase Phase 2
Start date June 2007
Completion date January 2009
View Details
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