Assessment of Postop Hypospadias Pain
Primary Purpose
Hypospadias
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen, Ibuprofen
Acetaminophen, Ibuprofen, Oxycodone
Sponsored by
About this trial
This is an interventional treatment trial for Hypospadias focused on measuring pediatric hypospadias repair
Eligibility Criteria
Inclusion Criteria:
All boys undergoing hypospadias repair at our institution between June 2020 and June 2021
Exclusion Criteria:
Boys who have a contraindication to caudal block or Acetaminophen, Ketorolac, Ibuprofen, or Oxycodone use. Boys over 2 years of age.
Sites / Locations
- OU Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
No opioid
Opioid
Arm Description
Acetaminophen every 6 hours and Ibuprofen every 6 hours
Acetaminophen every 6 hours, Ibuprofen every 6 hours, and Oxycodone every 6 hours as needed for breakthrough pain for 10 doses.
Outcomes
Primary Outcome Measures
Assessment of postop pain measured by Parents Postoperative Pain Measurement Scale
Assessment of postop pain as measured by Parents Postoperative Pain Measurement Scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04423107
Brief Title
Assessment of Postop Hypospadias Pain
Official Title
Assessment of Postoperative Pain in Boys Undergoing Hypospadias Repair
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
One of the most common pediatric urology procedures is hypospadias repair, a surgery to correct curvature of the penis and move the urethral meatus into the glans. A survey of pediatric urologists demonstrated that 72% of pediatric urologists prescribe opioid pain medication following the procedure. Using a validated questionnaire, the investigators aim to quantify how much opioid pain medication boys undergoing hypospadias repair require and if opioid pain medication can be eliminated from the routine postoperative medication regimen.
Detailed Description
Postoperative pain scores, as measured by the Parents' Postoperative Pain Measure scale, will not be statistically different in boys who receive opioid pain medication postoperatively compared to boys who do not.
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:
Acetaminophen (15 mg/kg) q6h and Ibuprofen (10 mg/kg) q6h
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypospadias
Keywords
pediatric hypospadias repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No opioid
Arm Type
Active Comparator
Arm Description
Acetaminophen every 6 hours and Ibuprofen every 6 hours
Arm Title
Opioid
Arm Type
Active Comparator
Arm Description
Acetaminophen every 6 hours, Ibuprofen every 6 hours, and Oxycodone every 6 hours as needed for breakthrough pain for 10 doses.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen, Ibuprofen
Other Intervention Name(s)
Tylenol (Acetaminophen)
Intervention Description
Acetaminophen (Tylenol) 15 mg/kg q6h and Ibuprofen (10 mg/kg) q6h
Intervention Type
Drug
Intervention Name(s)
Acetaminophen, Ibuprofen, Oxycodone
Other Intervention Name(s)
Tylenol (Acetaminophen)
Intervention Description
Acetaminophen (Tylenol) 15 mg/kg q6h, Ibuprofen q6h, and Oxycodone 0.1 mg/kg q6h
Primary Outcome Measure Information:
Title
Assessment of postop pain measured by Parents Postoperative Pain Measurement Scale
Description
Assessment of postop pain as measured by Parents Postoperative Pain Measurement Scale
Time Frame
1 year
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
All boys undergoing hypospadias repair at our institution
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All boys undergoing hypospadias repair at our institution between June 2020 and June 2021
Exclusion Criteria:
Boys who have a contraindication to caudal block or Acetaminophen, Ketorolac, Ibuprofen, or Oxycodone use. Boys over 2 years of age.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bhalaajee Meenakshi-Sundaram, MD
Phone
405-271-6900
Email
Bhalaajee-meenakshi-sundaram@ouhsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Felicia Kiplinger, BA
Phone
405-271-6900
Email
felicia-kiplinger@ouhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bhalaajee Meenakshi-Sundaram, MD
Organizational Affiliation
University of Oklahoma HSC, Dept. of Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
OU Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhalaajee Meenakshi-Sundaram, MD
Phone
405-271-6900
Email
bhalaajee-meenakshi-sundaram@ouhsc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Assessment of Postop Hypospadias Pain
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