Assessment of Postop Hypospadias Pain

NCT04423107 | Unknown Phase 3 FDA Drug

• 1 other identifier: Hypospadias Repair Project
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

pediatric hypospadias repair

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

No opioid

ACTIVE COMPARATOR

Acetaminophen every 6 hours and Ibuprofen every 6 hours

Drug: Acetaminophen, Ibuprofen

Opioid

ACTIVE COMPARATOR

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

Interventions

Acetaminophen, Ibuprofen DRUG

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

Also known as: Tylenol (Acetaminophen)

No opioid

Acetaminophen, Ibuprofen, Oxycodone DRUG

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

Also known as: Tylenol (Acetaminophen)

Opioid

Eligibility Criteria

• Age: 6 Months - 23 Months
• Gender Eligibility Details: All boys undergoing hypospadias repair at our institution
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All boys undergoing hypospadias repair at our institution between June 2020 and June 2021

You may not qualify if:

• Boys who have a contraindication to caudal block or Acetaminophen, Ketorolac, Ibuprofen, or Oxycodone use. Boys over 2 years of age.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Conditions

Hypospadias

Interventions

Acetaminophen; Ibuprofen; Oxycodone

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Bhalaajee Meenakshi-Sundaram, MD

  University of Oklahoma HSC, Dept. of Urology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bhalaajee Meenakshi-Sundaram, MD

CONTACT

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

Felicia Kiplinger, BA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 9, 2020
• Study Start: July 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: January 1, 2023
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)