Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
150 participants
INTERVENTIONAL
2020-07-01
2023-01-31
Brief Summary
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Detailed Description
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The long-term objectives of this study are to understand if pre and postoperative counseling and education along with proper surgical technique will result in less opioid prescriptions following hypospadias repair.
Children with suspected hypospadias will be seen and examined in clinic and offered surgery if appropriate. If the families elect for surgery, this will be performed by one of the investigators between 6-12 months of age. The surgical technique may vary among the investigators. Patients with severe hypospadias may require multiple surgeries for correction.
On the day of surgery, patients will be randomized to receive one of two pain medication regimens:
1. Acetaminophen (15 mg/kg) q6h and Ibuprofen (10 mg/kg) q6h
2. Acetaminophen q6h, Ibuprofen q6h, and Oxycodone 0.1 mg/kg q6h prn breakthrough pain for 10 doses Home dosing regimens will be started six hours after the last hospital dose of each medication. The families will be instructed as to when they can give oral medications at home. Lastly, families of both children in both groups will be instructed to contact the clinic or urologist on call if their children are experiencing uncontrolled pain. This may necessitate evaluation in person or adjustment of the current pain regimen. Any deviation from to prescribed pain regimen will be recorded for the study.
Patients will be contacted by phone at 1, 3, and 5 days postoperatively and given a validated questionnaire, the Parents' Postoperative Pain Measure scale, to objectively quantify how much discomfort boys in both groups experienced.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No opioid
Acetaminophen every 6 hours and Ibuprofen every 6 hours
Acetaminophen, Ibuprofen
Acetaminophen (Tylenol) 15 mg/kg q6h and Ibuprofen (10 mg/kg) q6h
Opioid
Acetaminophen every 6 hours, Ibuprofen every 6 hours, and Oxycodone every 6 hours as needed for breakthrough pain for 10 doses.
Acetaminophen, Ibuprofen, Oxycodone
Acetaminophen (Tylenol) 15 mg/kg q6h, Ibuprofen q6h, and Oxycodone 0.1 mg/kg q6h
Interventions
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Acetaminophen, Ibuprofen
Acetaminophen (Tylenol) 15 mg/kg q6h and Ibuprofen (10 mg/kg) q6h
Acetaminophen, Ibuprofen, Oxycodone
Acetaminophen (Tylenol) 15 mg/kg q6h, Ibuprofen q6h, and Oxycodone 0.1 mg/kg q6h
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Months
23 Months
MALE
No
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Bhalaajee Meenakshi-Sundaram, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma HSC, Dept. of Urology
Locations
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OU Medical Center
Oklahoma City, Oklahoma, United States
Countries
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Central Contacts
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Facility Contacts
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Bhalaajee Meenakshi-Sundaram, MD
Role: primary
Other Identifiers
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Hypospadias Repair Project
Identifier Type: -
Identifier Source: org_study_id