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

State University of New York at Buffalo70 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Pain

Interventions

Lidocaine Cream 4%DRUG

Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure

PlaceboDRUG

inactive placebo without LMX4

Eligibility

Sex: ALLMin age: 0 DaysMax age: 60 Days

Medical Language ↔ Plain English

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

Locations (1)

Women's and Children's Hospital of Buffalo

Buffalo, New York, United States

Outcomes

Primary Outcomes

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

Time frame: 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 Outcomes

Time of Procedure

Time, measured in minutes, required to complete procedure from infant's presentation to the Emergency Department

Time frame: Infant's stay in the Emergency Department

Percentage of Procedures With Success

Whether the Lumbar Puncture resulted in recovery of spinal fluid that could be sent for usual testing

Time frame: During patient's Emergency Department Stay

Data from ClinicalTrials.gov

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