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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No opioid | Active Comparator | Acetaminophen every 6 hours and Ibuprofen every 6 hours |
|
| Opioid | Active Comparator | Acetaminophen every 6 hours, Ibuprofen every 6 hours, and Oxycodone every 6 hours as needed for breakthrough pain for 10 doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen, Ibuprofen | Drug | Acetaminophen (Tylenol) 15 mg/kg q6h and Ibuprofen (10 mg/kg) q6h |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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.
All boys undergoing hypospadias repair at our institution
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bhalaajee Meenakshi-Sundaram, MD | Contact | 405-271-6900 | Bhalaajee-meenakshi-sundaram@ouhsc.edu | |
| Felicia Kiplinger, BA | Contact | 405-271-6900 | felicia-kiplinger@ouhsc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bhalaajee Meenakshi-Sundaram, MD | University of Oklahoma HSC, Dept. of Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OU Medical Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Term |
|---|---|
| D007021 | Hypospadias |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Acetaminophen, Ibuprofen, Oxycodone | Drug | Acetaminophen (Tylenol) 15 mg/kg q6h, Ibuprofen q6h, and Oxycodone 0.1 mg/kg q6h |
|
|
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |