Assessment of Postop Hypospadias Pain

Hypospadias Clinical Trial

Official title:

Assessment of Postoperative Pain in Boys Undergoing Hypospadias Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04423107
• Other study ID #: Hypospadias Repair Project
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2020
• Est. completion date: January 2023

Study information

• Verified date: July 2020
• Source: University of Oklahoma
• Contact: Bhalaajee Meenakshi-Sundaram, MD
• Phone: 405-271-6900
• Email: Bhalaajee-meenakshi-sundaram[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 2023
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Months to 23 Months

Eligibility

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.

Related Conditions & MeSH terms

• Hypospadias

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	OU Medical Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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