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

This study has been completed.
Sponsor:
Collaborator:
Ferndale Laboratories, Inc.
Information provided by:
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT00533468
First received: September 19, 2007
Last updated: March 23, 2011
Last verified: March 2011
  Purpose

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


Condition Intervention Phase
Pain
Drug: Lidocaine Cream 4%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: "Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."

Resource links provided by NLM:


Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • Neonatal Facial Coding System score [ Time Frame: Over the duration of the procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. Time required to complete procedure from infant's presentation to the Emergency Department. 2. Success of the procedure [ Time Frame: Infant's stay in the Emergency Department ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: March 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lidocaine Cream 4%
    Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure
    Other Name: LMX4
Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 60 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533468

Locations
United States, New York
Women's and Children's Hospital of Buffalo
Buffalo, New York, United States, 14222
Sponsors and Collaborators
State University of New York at Buffalo
Ferndale Laboratories, Inc.
Investigators
Principal Investigator: James L Reingold, MD SUNY Buffalo
  More Information

No publications provided

Responsible Party: James Reingold, M.D., State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT00533468     History of Changes
Other Study ID Numbers: 05-130
Study First Received: September 19, 2007
Last Updated: March 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by State University of New York at Buffalo:
pain
lumbar puncture
neonates
infants
emergency department
topical anesthesia
LMX4

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014