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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00530803
First Posted: September 17, 2007
Last Update Posted: October 27, 2009
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.
Information provided by:
Montefiore Medical Center
  Purpose
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 Intervention
Pain Drug: EMLA Cream Drug: Synera Patch

Study Type: Interventional
Study Design: 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

Further study details as provided by Montefiore Medical Center:

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

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

Estimated Enrollment: 100
Study Start Date: September 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00530803


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

Publications:

ClinicalTrials.gov Identifier: NCT00530803     History of Changes
Other Study ID Numbers: MontefioreMC
First Submitted: September 13, 2007
First Posted: September 17, 2007
Last Update Posted: October 27, 2009
Last Verified: October 2009

Keywords provided by Montefiore Medical Center:
pain
venipuncture
children

Additional relevant MeSH terms:
EMLA
Lidocaine
Prilocaine
Anesthetics, Local
Anesthetics
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