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"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00533468
First Posted: September 21, 2007
Last Update Posted: March 24, 2011
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.
Collaborator:
Ferndale Laboratories, Inc.
Information provided by:
State University of New York at Buffalo
September 19, 2007
September 21, 2007
March 24, 2011
March 2007
March 2008   (Final data collection date for primary outcome measure)
Neonatal Facial Coding System score [ Time Frame: Over the duration of the procedure ]
Same as current
Complete list of historical versions of study NCT00533468 on ClinicalTrials.gov Archive Site
1. Time required to complete procedure from infant's presentation to the Emergency Department. 2. Success of the procedure [ Time Frame: Infant's stay in the Emergency Department ]
Same as current
Not Provided
Not Provided
 
"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."
"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."
The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap).
Pain of infants will be measured using the Neonatal Facial Coding System by videotaping the infant's face while they undergo the procedure. A comparison between the group that received active drug and the group that received placebo will allow a measurement of the difference, if any, of the pain experienced during the procedure of the infants.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Pain
Drug: Lidocaine Cream 4%
Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure
Other Name: LMX4
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
March 2008
March 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Full term (>=37 weeks gestation)
  • Age 0-60 Days
  • Undergoing Lumbar Puncture

Exclusion Criteria:

  • Unstable
  • Premature (<37 weeks gestation)
  • Allergy to study medicine
  • Parent refusal of consent
Sexes Eligible for Study: All
up to 60 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00533468
05-130
Yes
Not Provided
Not Provided
James Reingold, M.D., State University of New York at Buffalo
State University of New York at Buffalo
Ferndale Laboratories, Inc.
Principal Investigator: James L Reingold, MD SUNY Buffalo
State University of New York at Buffalo
March 2011

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