Phase 4
N=70
"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."
Pain
Bottom Line
View on ClinicalTrials.gov: NCT00533468 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Neonatal Facial Coding System Score — 4.6; 3.9; 8.3; 8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lidocaine Cream 4% (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neonatal Facial Coding System Score |
4.6; 3.9; 8.3; 8; 7.6; 6.7 | — |
| SECONDARY Time of Procedure |
31; 36 | — |
| SECONDARY Percentage of Procedures With Success |
96; 75 | — |
Summary
The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00533468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.