Assessment of Postop Hypospadias Pain

U

University of Oklahoma (OU)

Status and phase

Unknown
Phase 3

Conditions

Hypospadias

Treatments

Drug: Acetaminophen, Ibuprofen
Drug: Acetaminophen, Ibuprofen, Oxycodone

Study type

Interventional

Funder types

Other

Identifiers

NCT04423107
Hypospadias Repair Project

Details and patient eligibility

About

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.

Full 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: Acetaminophen (15 mg/kg) q6h and Ibuprofen (10 mg/kg) q6h 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.

Enrollment

150 estimated patients

Sex

Male

Ages

6 to 23 months old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

No opioid
Active Comparator group
Description:
Acetaminophen every 6 hours and Ibuprofen every 6 hours
Treatment:
Drug: Acetaminophen, Ibuprofen
Opioid
Active Comparator group
Description:
Acetaminophen every 6 hours, Ibuprofen every 6 hours, and Oxycodone every 6 hours as needed for breakthrough pain for 10 doses.
Treatment:
Drug: Acetaminophen, Ibuprofen, Oxycodone

Trial contacts and locations

1

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Central trial contact

Bhalaajee Meenakshi-Sundaram, MD; Felicia Kiplinger, BA

Data sourced from clinicaltrials.gov

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