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

Montefiore Medical Center100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

100

Conditions

Pain Needle Phobia

Interventions

EMLA CreamDRUG

60 minutes x1

Synera PatchCOMBINATION_PRODUCT

20 minutes x1

Eligibility

Sex: ALLMin age: 4 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital at Montefiore

The Bronx, New York, United States

Outcomes

Primary Outcomes

Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale.

Participants were asked to report their level of pain using a 6-point Wong-Baker FACES Pain Rating Scale ranging from 0, "no pain," to 5, "the most pain you can have." The Wong-Baker FACES Pain Rating Scale is a validated tool for measuring pain in patients as young as 3 years old. A FACES pain score less than or equal to 2 is considered no pain to mild pain, and is clinically acceptable. Studies have shown average FACES pain scores for children receiving vascular access with placebo to be 2.2 to 3.5.

Time frame: immediately after completion of venipuncture

Secondary Outcomes

Parent Rating of Child's Pain Using a 6-point NRS

The Numerical Rating Scale (NRS) is a 6-point rating scale where 0= no pain and 5 = worst pain. Parents reported their own subjective evaluation of participants pain level. Each participant had only one parental assessment. Total number of parental assessment for each pain level on the 6-point NRS is reported as total number of participants experiencing that pain level.

Time frame: immediately after venipuncture is completed

Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS

The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain experienced by the participants at tourniquet placement. Total number of participants subjectively evaluated as experiencing each pain level is reported.

Time frame: before venipuncture

Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS

The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain experienced by the participants at needle insertion. Total number of participants subjectively evaluated as experiencing each pain level is reported.

Data from ClinicalTrials.gov

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