- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00847093
LMX-4 for Postoperative Pain Management in Infants and Children Undergoing Penoplasty Surgery (LMX-4)
June 30, 2011 updated by: Ferndale Laboratories, Inc.
Post-Operative Pain Control in Children and Infants Undergoing Penoplasty: A Randomized Control Trial of a Local Anesthetic Cream Placebo.
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 .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60614
- Children's Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 3 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cream
Experimental group receiving either medicated topical cream or placebo cream
|
One inch every six hours
One inch every six hours
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reducing by 50% the need for rescue analgesia between the LMX4 cream or placebo cream group
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Santhanam Suresh, MD, Ann & Robert H Lurie Children's Hospital of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
February 18, 2009
First Submitted That Met QC Criteria
February 18, 2009
First Posted (Estimate)
February 19, 2009
Study Record Updates
Last Update Posted (Estimate)
July 1, 2011
Last Update Submitted That Met QC Criteria
June 30, 2011
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- LMX-944700
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post-Operative Pain
-
Kaohsiung Medical University Chung-Ho Memorial...Not yet recruitingPostoperative Complications | Chronic Post Operative Pain | Acute Post Operative PainTaiwan
-
MercyOne Des Moines Medical CenterTerminatedPost Operative Pain | Post Operative Nausea and VomitingUnited States
-
E-DA HospitalNot yet recruitingCesarean Section | Post Operative Pain, Acute | Post Operative Pain, ChronicTaiwan
-
Assiut UniversityRecruitingPost Operative PainEgypt
-
Ahmed M Maged, MDNot yet recruiting
-
Pakistan Institute of Medical SciencesRecruiting
-
National Trauma CenterNot yet recruiting
-
Armed Forces Institute of Dentistry, PakistanRecruitingPost Operative PainPakistan
-
National Cancer Institute, EgyptRecruitingPost Operative PainEgypt
-
British University In EgyptRecruitingPost Operative PainEgypt
Clinical Trials on LMX4
-
State University of New York at BuffaloFerndale Laboratories, Inc.Completed
-
Jenny Boucher, PharmDCompletedPain | AnxietyUnited States
-
University of Alabama at BirminghamCompleted
-
Milton S. Hershey Medical CenterSolta MedicalWithdrawn