Recruiting
Phase 3

Opioid Pain Medication

Sponsor:

University of Oklahoma

Code:

NCT04423107

Conditions

Hypospadias

Eligibility Criteria

Sex: Male

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Acetaminophen, Ibuprofen

Acetaminophen, Ibuprofen, Oxycodone

Study Details

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.

Conditions

Hypospadias

Study ID

NCT04423107

Start date

Jul 1, 2020

Status verified date

Jul, 2020

Completion date

Jan, 2023

Anticipated

Primary completion date

Jun, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0 - 1

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: No opioid

Acetaminophen every 6 hours and Ibuprofen every 6 hours

active comparator: Opioid

Acetaminophen every 6 hours, Ibuprofen every 6 hours, and Oxycodone every 6 hours as needed for breakthrough pain for 10 doses.

Interventions

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

Primary outcome measure

  • Assessment of postop pain measured by Parents Postoperative Pain Measurement Scale [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Bhalaajee Meenakshi-Sundaram, MD

405-271-6900Bhalaajee-meenakshi-sundaram@ouhsc.edu

Felicia Kiplinger, BA

405-271-6900felicia-kiplinger@ouhsc.edu

Locations

OU Medical Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Bhalaajee Meenakshi-Sundaram, MD

405-271-6900bhalaajee-meenakshi-sundaram@ouhsc.edu

More Information

Sponsor

University of Oklahoma

Last update posted

Jul 31, 2020

Last verified

Jul, 2020

Keywords

  • pediatric hypospadias repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2020-07-31.