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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533468
• Other study ID #: 05-130
• Status: Completed
• Phase: Phase 4
• Start date: March 2007
• Est. completion date: March 2008

Study information

• Verified date: November 2022
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 60 Days

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Lidocaine Cream 4%
Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure
• Placebo
inactive placebo without LMX4

Locations

Country	Name	City	State
United States	Women's and Children's Hospital of Buffalo	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	Ferndale Laboratories, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal Facial Coding System Score	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	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
Secondary	Time of Procedure	Time, measured in minutes, required to complete procedure from infant's presentation to the Emergency Department	Infant's stay in the Emergency Department
Secondary	Percentage of Procedures With Success	Whether the Lumbar Puncture resulted in recovery of spinal fluid that could be sent for usual testing	During patient's Emergency Department Stay