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

NCT00533468 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-12-28

Study results available
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Summary

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

Conditions

Interventions

DRUG

Lidocaine Cream 4%

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

DRUG

Placebo

inactive placebo without LMX4

Sponsors & Collaborators

  • Ferndale Laboratories, Inc.

    collaborator INDUSTRY

  • State University of New York at Buffalo

    lead OTHER

Principal Investigators

  • James L Reingold, MD · SUNY Buffalo

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Days
Max Age
60 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00533468 on ClinicalTrials.gov