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Assessment of Postop Hypospadias Pain

NCT04423107 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-07-31

No results posted yet for this study

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

Interventions

DRUG

Acetaminophen, Ibuprofen

Acetaminophen (Tylenol) 15 mg/kg q6h and Ibuprofen (10 mg/kg) q6h

DRUG

Acetaminophen, Ibuprofen, Oxycodone

Acetaminophen (Tylenol) 15 mg/kg q6h, Ibuprofen q6h, and Oxycodone 0.1 mg/kg q6h

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Bhalaajee Meenakshi-Sundaram, MD · University of Oklahoma HSC, Dept. of Urology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
23 Months
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-06-30
Completion
2023-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04423107 on ClinicalTrials.gov