Official Title
"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."
Phase
Phase 4Lead Sponsor
State University of New YorkStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
PainIntervention/Treatment
lidocaine ...Study Participants
70The 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.
Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure
inactive placebo without LMX4
Active 4% Lidocaine topical cream (LMX4 cream) applied under occlusive dressing
Placebo Cream made on same run at factory but without active Lidocaine 4% drug
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
| Event Type | Organ System | Event Term | Placebo | Active Drug |
|---|
10 measures of pain, all scored 0 or 1, high score means more pain. No pain would be recorded as zero, maximum pain recorded as 10
Time, measured in minutes, required to complete procedure from infant's presentation to the Emergency Department
Whether the Lumbar Puncture resulted in recovery of spinal fluid that could be sent for usual testing
