"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:
Collaborator:
Ferndale Laboratories, Inc.
Information provided by:
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT00533468
First received: September 19, 2007
Last updated: March 23, 2011
Last verified: March 2011

September 19, 2007
March 23, 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 ] [ Designated as safety issue: No ]
Neonatal Facial Coding System score [ Time Frame: Over the duration of the procedure ]
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 ] [ Designated as safety issue: No ]
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 ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
up to 60 Days
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00533468
05-130
Yes
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