"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."
This study is currently recruiting participants.
Verified by State University of New York at Buffalo September 2007
Sponsors and Collaborators: |
State University of New York at Buffalo
Ferndale Labs, Inc. |
Information provided by: |
State University of New York at Buffalo |
ClinicalTrials.gov Identifier: |
NCT00533468 |
|
Purpose
The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap).
Condition |
Intervention |
Phase |
Pain |
Drug: Lidocaine Cream 4% |
Phase IV |
MedlinePlus related topics: Pain
Study Type: Interventional
Study Design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Number of arms in study: 1
Primary Outcome Measures:
- Neonatal Facial Coding System score [Time Frame: Over the duration of the procedure]
Secondary Outcome Measures:
- 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]
Further study details as provided by State University of New York at Buffalo:
Total Enrollment: 70
Study start: March 2007; Expected completion: October 2007
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.