NCT00533468

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: 0 Days – 60 Days
• Healthy volunteers: Not accepted

Summary

The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap).

Detailed description

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Lidocaine Cream 4%	Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure
DRUG	Placebo	inactive placebo without LMX4

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2007-09-21
• Last updated: 2022-12-28
• Results posted: 2022-12-28

Locations

1 site across 1 country: United States