Conditions: Pain Needle Phobia
Keywords: EMLA venipuncture children Synera patch pediatric Lidocaine/prilocaine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 100
Healthy volunteers: no

Brief 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.

Detailed 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.

Arms:
arm 1: 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. arm 2: Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.

Interventions: intervention 1: EMLA Cream intervention 2: Synera Patch
Intervention descriptions: intervention 1: 60 minutes x1 intervention 2: 20 minutes x1

Protocol document: