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

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Lidocaine Cream 4%

• Registration Number: NCT00533468
• Lead Sponsor: State University of New York at Buffalo

Brief 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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-09-19
• Study First Submitted QC: 2007-09-19
• Study First Posted: 2007-09-21
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2020-09-07
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-28
• Last Update Submitted: 2022-11-28
• Results First Posted: 2022-12-28
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo Cream made on same run at factory but without active Lidocaine 4% drug
Active Drug	Lidocaine Cream 4%	Active 4% Lidocaine topical cream (LMX4 cream) applied under occlusive dressing

Primary Outcome Measures

Name	Time	Method
Neonatal Facial Coding System Score	Score was measured at baseline, upon positioning for the procedure, immediately prior to needle insertion, during needle insertion, 1 minute post-needle insertion, and post-procedure when the infant had recovered from the procedure and was swaddled	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

Secondary Outcome Measures

Name	Time	Method
Time of Procedure	Infant's stay in the Emergency Department	Time, measured in minutes, required to complete procedure from infant's presentation to the Emergency Department
Percentage of Procedures With Success	During patient's Emergency Department Stay	Whether the Lumbar Puncture resulted in recovery of spinal fluid that could be sent for usual testing

Trial Locations

Locations (1)

Women's and Children's Hospital of Buffalo; 🇺🇸 Buffalo, New York, United States