ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00533468
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : March 24, 2011
Sponsor:
Collaborator:
Ferndale Laboratories, Inc.
Information provided by:
State University of New York at Buffalo

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

Condition or disease Intervention/treatment Phase
Pain Drug: Lidocaine Cream 4% Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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."
Study Start Date : March 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Lidocaine Cream 4%
    Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure
    Other Name: LMX4


Primary Outcome Measures :
  1. Neonatal Facial Coding System score [ Time Frame: Over the duration of the procedure ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 60 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: March 24, 2011
Last Verified: March 2011

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
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action