At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 70 enrolled
Drug / intervention
Lidocaine Cream 4% +1 moredrug
Likely dose
Lidocaine Cream 4% 2gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."
In Brief
A Phase 4 clinical trial evaluating Lidocaine Cream 4% and Placebo for Pain. Completed, enrolled 70 participants across 1 site.
Detailed Summary
The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
CollaboratorsFerndale Laboratories, Inc.
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
First PostedSep 2007
Primary CompletionMar 2008
TodayJul 2026
First PostedSep 21, 2007
Enrollment StartMar 1, 2007
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.8 years ago
Interventions
Lidocaine Cream 4%drug
Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure
Placebodrug
inactive placebo without LMX4