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LMX-4 for Postoperative Pain Management in Infants and Children Undergoing Penoplasty Surgery

This study has been completed.
Sponsor:
Information provided by:
Ferndale Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00847093
First received: February 18, 2009
Last updated: June 30, 2011
Last verified: February 2009
History of Changes
  Purpose

After surgery on his penis, your child will probably have some pain. The investigators will give you a prescription for acetaminophen (Tylenol) with codeine, given by mouth (orally), for pain. In this study, the investigators want to see if a local anesthetic cream applied to the base of the shaft of the penis can reduce the need for oral medicine .


Condition Intervention Phase
Post-Operative Pain
 Drug: LMX4
Drug: LMX4 Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Post-Operative Pain Control in Children and Infants Undergoing Penoplasty: A Randomized Control Trial of a Local Anesthetic Cream Placebo.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ferndale Laboratories, Inc.:

Primary Outcome Measures:
  • Reducing by 50% the need for rescue analgesia between the LMX4 cream or placebo cream group [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cream
Experimental group receiving either medicated topical cream or placebo cream
 Drug: LMX4
One inch every six hours
Other Name: LMX4
Drug: LMX4 Placebo
One inch every six hours
Other Name: Placebo cream

Detailed Description:

Your child will receive a general anesthetic for the surgery. After your child is asleep, he will receive a local anesthetic injection in the area of the tailbone (normal procedure for this surgery). At the end of the operation your child will go to the recovery room. At the time of discharge from the hospital, we will be give you the prescription for acetaminophen with codeine (standard medication given for children undergoing surgery on the penis), and a tube of cream. The tube will contain either a local anesthetic cream (LMX-4)® or a cream with no active medicine (a placebo). We want you to apply the cream to the base of your son's penis every six hours. Which kind of tube you get will be picked randomly (similar to drawing numbers out of a hat) by a computer. Thirty minutes after applying the study cream, or sooner if needed, if you think your child needs pain medication, you may give the oral pain medicine (Tylenol with codeine as prescribed on the bottle). You may continue to apply the cream and give oral medicine every six hours as long as you think your child needs pain medicine for a maximum of 7 days. The cream can also be re-applied when changing diapers to facilitate the continued use of the cream even if it is sooner than the suggested 6 hours.

  Eligibility

Ages Eligible for Study:   3 Months to 3 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is 3 months to less than 3 years of age (at least 3 months old but not yet reached his 3rd birthday at the time of enrollment).
  • Subject has presented with a clinical diagnosis of buried penis
  • With the exception of the disease being studied, subject is in good health in the opinion of the investigator.
  • Subject and parent(s) or legal guardian(s) must agree to the requirements and restrictions of the study and will appear for all required examinations.
  • Subject's parent or legal guardian must sign a written, IRB-approved informed consent prior to admission into the study, and must be able to understand that consent form.

Exclusion Criteria:

  • Subject has a known hypersensitivity to any component of the study medication.
  • Subject has history or evidence of other conditions that would interfere with evaluation of the study medication.
  • Subject has been treated with another investigational device or drug within 30 days prior to study enrollment, or is participating in a clinical trial at the time of enrollment or intends to participate in a clinical trial concurrent with this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847093

Locations
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Ferndale Laboratories, Inc.
Investigators
Principal Investigator: Santhanam Suresh, MD Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

No publications provided

Responsible Party: Santhanam Suresh, MD, Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT00847093     History of Changes
Other Study ID Numbers: LMX-944700
Study First Received: February 18, 2009
Last Updated: June 30, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
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

ClinicalTrials.gov processed this record on May 16, 2013