Clinical trial NCT00530803: The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children
Official title: The Efficacy of the Eutectic Mixture of Local Anesthetics (EMLA) Cream Versus the Synera Patch for Pain Reduction During Venipuncture in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Needle Phobia
Keywords: EMLA
venipuncture
children
Synera patch
pediatric
Lidocaine/prilocaine
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2007-09-17
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale.
timeFrame: immediately after completion of venipuncture
Secondary outcomes:
measure: Parent Rating of Child's Pain Using a 6-point NRS
timeFrame: immediately after venipuncture is completed
measure: Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS
timeFrame: before venipuncture
measure: Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS
timeFrame: during needle insertion
measure: Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS
timeFrame: 5 minutes post venipuncture
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
Study officials:
affiliation: Children's Hospital at Montefiore
name: Catherine C Skae, MD
role: PRINCIPAL_INVESTIGATOR
References:
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