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

NCT00847093 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-07-01

No results posted yet for this study

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 .

Conditions

  • Post-Operative Pain

Interventions

DRUG

LMX4

One inch every six hours

DRUG

LMX4 Placebo

One inch every six hours

Sponsors & Collaborators

  • Ferndale Laboratories, Inc.

    lead INDUSTRY

Principal Investigators

  • Santhanam Suresh, MD · Ann & Robert H Lurie Children's Hospital of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
3 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00847093 on ClinicalTrials.gov