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The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children
This study has been completed.
Study NCT00530803   Information provided by Montefiore Medical Center
First Received: September 13, 2007   Last Updated: October 26, 2009   History of Changes

September 13, 2007
October 26, 2009
September 2007
January 2009   (final data collection date for primary outcome measure)
Child rating of Pain [ Time Frame: after venipuncture ]
Same as current
Complete list of historical versions of study NCT00530803 on ClinicalTrials.gov Archive Site
  • Parent rating of child's pain [ Time Frame: after venipuncture ]
  • Blinded observer ratings of child's pain [ Time Frame: before, during, and after venipuncture ]
Same as current
 
The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children
The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture 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.

 
 
Interventional
Supportive Care, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment
Pain
  • Drug: EMLA Cream
  • Drug: Synera Patch
  • Active Comparator: EMLA Cream will be applied to venipuncture site
  • Active Comparator: The Synera Patch will be applied to the venipuncture site

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
100
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
4 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00530803
 
MontefioreMC
Montefiore Medical Center
 
Principal Investigator: Catherine C Skae, MD Children's Hospital at Montefiore
Montefiore Medical Center
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP