Assessment of Postop Hypospadias Pain

Assessment of Postoperative Pain in Boys Undergoing Hypospadias Repair

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.

Study Overview

• Status: Recruiting
• Conditions: Hypospadias
• Intervention / Treatment: Drug: Acetaminophen, Ibuprofen; Drug: Acetaminophen, Ibuprofen, Oxycodone

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:

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Bhalaajee Meenakshi-Sundaram, MD; Phone Number: 405-271-6900; Email: bhalaajee-meenakshi-sundaram@ouhsc.edu
• Study Contact Backup: Name: Felicia Kiplinger, BA; Phone Number: 405-271-6900; Email: felicia-kiplinger@ouhsc.edu

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • OU Medical Center
      • Contact: Bhalaajee Meenakshi-Sundaram, MD; Phone Number: 405-271-6900; Email: bhalaajee-meenakshi-sundaram@ouhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No opioid; Acetaminophen every 6 hours and Ibuprofen every 6 hours	Drug: Acetaminophen, Ibuprofen; Acetaminophen (Tylenol) 15 mg/kg q6h and Ibuprofen (10 mg/kg) q6h; Other Names: Tylenol (Acetaminophen)
Active Comparator: Opioid; Acetaminophen every 6 hours, Ibuprofen every 6 hours, and Oxycodone every 6 hours as needed for breakthrough pain for 10 doses.	Drug: Acetaminophen, Ibuprofen, Oxycodone; Acetaminophen (Tylenol) 15 mg/kg q6h, Ibuprofen q6h, and Oxycodone 0.1 mg/kg q6h; Other Names: Tylenol (Acetaminophen)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of postop pain measured by Parents Postoperative Pain Measurement Scale	Assessment of postop pain as measured by Parents Postoperative Pain Measurement Scale	1 year

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Bhalaajee Meenakshi-Sundaram, MD, University of Oklahoma HSC, Dept. of Urology

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: pediatric hypospadias repair
• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Hypospadias; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Ibuprofen; Oxycodone
• Other Study ID Numbers: Hypospadias Repair Project

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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