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

This study has been completed.
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00530803
First received: September 13, 2007
Last updated: October 26, 2009
Last verified: October 2009
  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: Double Blind (Subject, Caregiver, 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

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 13, 2007
Last Updated: October 26, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Montefiore Medical Center:
pain
venipuncture
children

Additional relevant MeSH terms:
EMLA
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Combined

ClinicalTrials.gov processed this record on September 14, 2014