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OpenTrials
Completed

NCT Number: NCT00533468

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

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

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Key information

Conditions

Pain Disease Attributes Emergencies Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

0 day–60 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Women's and Children's Hospital of Buffalo

Buffalo, New York, 14222, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine Cream 4%

Drug

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

Other names: LMX4

Placebo

Drug

inactive placebo without LMX4

Primary outcomes

  1. Neonatal Facial Coding System Score

    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

    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 outcomes

  1. Time of Procedure

    Time frame: Infant's stay in the Emergency Department

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

  2. Percentage of Procedures With Success

    Time frame: During patient's Emergency Department Stay

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

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • Ferndale Laboratories, Inc.

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 21, 2007
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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