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

August 29, 2018 updated by: Montefiore Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Children's Hospital at Montefiore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EMLA Cream
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.
Drug: EMLA Cream
60 minutes x1
Other Names:
  • Lidocaine/prilocaine cream
Active Comparator: Synera Patch
Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.
Combination product: Synera Patch
20 minutes x1
Other Names:
  • Lidocaine/tetracaine patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale.
Time Frame: immediately after completion of venipuncture
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.
immediately after completion of venipuncture

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent Rating of Child's Pain Using a 6-point NRS
Time Frame: immediately after venipuncture is completed
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.
immediately after venipuncture is completed
Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS
Time Frame: before venipuncture
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.
before venipuncture
Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS
Time Frame: during needle insertion
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.
during needle insertion
Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS
Time Frame: 5 minutes post venipuncture
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 participants were experiencing 5 minutes after the venipuncture was completed. Total number of participants subjectively evaluated as experiencing each pain level is reported.
5 minutes post venipuncture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Catherine C Skae, MD, Children's Hospital at Montefiore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 13, 2007

First Submitted That Met QC Criteria

September 13, 2007

First Posted (Estimate)

September 17, 2007

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 29, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-06-159

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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