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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00530803
Recruitment Status : Completed
First Posted : September 17, 2007
Last Update Posted : October 27, 2009
Information provided by:
Montefiore Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: EMLA Cream Drug: Synera Patch Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children
Study Start Date : September 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Arm Intervention/treatment
Active Comparator: A, 1
EMLA Cream will be applied to venipuncture site
Drug: EMLA Cream
60 minutes x1
Active Comparator: A, 2
The Synera Patch will be applied to the venipuncture site
Drug: Synera Patch
20 minutes x1

Primary Outcome Measures :
  1. Child rating of Pain [ Time Frame: after venipuncture ]

Secondary Outcome Measures :
  1. Parent rating of child's pain [ Time Frame: after venipuncture ]
  2. Blinded observer ratings of child's pain [ Time Frame: before, during, and after venipuncture ]

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 sdter type, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00530803

United States, New York
Children's Hospital at Montefiore
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Principal Investigator: Catherine C Skae, MD Children's Hospital at Montefiore

Publications: Identifier: NCT00530803     History of Changes
Other Study ID Numbers: MontefioreMC
First Posted: September 17, 2007    Key Record Dates
Last Update Posted: October 27, 2009
Last Verified: October 2009

Keywords provided by Montefiore Medical Center:

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Combined
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action