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

This study is currently recruiting participants.

Verified by State University of New York at Buffalo, September 2007

Sponsors and Collaborators:	State University of New York at Buffalo Ferndale Labs, Inc.
Information provided by:	State University of New York at Buffalo
ClinicalTrials.gov Identifier:	NCT00533468

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 IV

MedlinePlus related topics: Anesthesia

Drug Information available for: Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study

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 ]

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 ]

Estimated Enrollment:	70
Study Start Date:	March 2007
Estimated Study Completion Date:	October 2007

Intervention Details:

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

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

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

Contacts

Contact: James L Reingold, MD	480-512-3056	jamesreingold@hotmail.com
Contact: Haiping Qiao, MD	716-878-7109	hqiao@upa.chob.edu

Locations

United States, New York
Women's and Children's Hospital of Buffalo	Recruiting
Buffalo, New York, United States, 14222
Contact: Haiping Qiao, MD 716-878-7109 hqiao@upa.chob.edu
Contact: Kathy Lillis, MD 716-878-7109 klillis@upa.chob.edu

Sponsors and Collaborators

State University of New York at Buffalo

Ferndale Labs, Inc.

Investigators

Principal Investigator:

James L Reingold, MD

SUNY Buffalo

More Information

Study ID Numbers:	05-130
Study First Received:	September 19, 2007
Last Updated:	September 24, 2007
ClinicalTrials.gov Identifier:	NCT00533468
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

Study placed in the following topic categories:

Lidocaine
Emergencies
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents

Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 16, 2009