Status:
COMPLETED
LMX-4 for Postoperative Pain Management in Infants and Children Undergoing Penoplasty Surgery
Lead Sponsor:
Ferndale Laboratories, Inc.
Conditions:
Post-Operative Pain
Eligibility:
MALE
3-3 years
Phase:
PHASE4
Brief Summary
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...
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). ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00847093
Start Date
September 1 2008
End Date
July 1 2009
Last Update
July 1 2011
Active Locations (1)
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1
Children's Memorial Hospital
Chicago, Illinois, United States, 60614