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

Completed · Phase 4 · Has a placebo group

Conditions studied: Post-Operative Pain

In brief

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 .

Key facts

Study ID

NCT00847093

Run by

Ferndale Laboratories, Inc.

People needed

50

Starts

2008-09-01

Expected to finish

2009-07-01

Last updated by the study team

2011-07-01

Who can join

Age: 0 and older, up to 3. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Memorial Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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