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

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

Detailed Description
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Lidocaine Cream 4%
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 60 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Drug<br>Active 4% Lidocaine topical cream (LMX4 cream) applied under occlusive dressing | Drug: Lidocaine Cream 4%<br>* Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure<br>* Other names: LMX4;|
| Placebo Comparator: Placebo<br>Placebo Cream made on same run at factory but without active Lidocaine 4% drug | Drug: Placebo<br>* inactive placebo without LMX4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, lumbar puncture, neonates, infants, emergency department, topical anesthesia, LMX4