LMX-4 for Postoperative Pain Management in Infants and Children Undergoing Penoplasty Surgery
LMX-4
Post-Operative Pain Control in Children and Infants Undergoing Penoplasty: A Randomized Control Trial of a Local Anesthetic Cream Placebo.
1 other identifier
interventional
50
1 country
1
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 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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 postoperative-pain
Started Sep 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 18, 2009
CompletedFirst Posted
Study publicly available on registry
February 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJuly 1, 2011
February 1, 2009
10 months
February 18, 2009
June 30, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Reducing by 50% the need for rescue analgesia between the LMX4 cream or placebo cream group
7 days
Study Arms (1)
Cream
EXPERIMENTALExperimental group receiving either medicated topical cream or placebo cream
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Santhanam Suresh, MD
Ann & Robert H Lurie Children's Hospital of Chicago
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 18, 2009
First Posted
February 19, 2009
Study Start
September 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
July 1, 2011
Record last verified: 2009-02