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

Study Overview
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Brief Summary
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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 .

Detailed Description
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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.

Official Title
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Post-Operative Pain Control in Children and Infants Undergoing Penoplasty: A Randomized Control Trial of a Local Anesthetic Cream Placebo.

Conditions
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Post-Operative Pain

Intervention / Treatment
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* Drug: LMX4
* Drug: LMX4 Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cream<br>Experimental group receiving either medicated topical cream or placebo cream | Drug: LMX4<br>* One inch every six hours<br>Drug: LMX4 Placebo<br>* One inch every six hours<br>* Other names: Placebo cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing by 50% the need for rescue analgesia between the LMX4 cream or placebo cream group |  | 7 days |