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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Male

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 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 .

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferndale Laboratories, Inc.
• Treatments: Lidocaine

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.