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临床试验/NCT04423107
NCT04423107Unknown3 期

Assessment of Postoperative Pain in Boys Undergoing Hypospadias Repair

University of Oklahoma1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
150
试验地点
1
主要终点
Assessment of postop pain measured by Parents Postoperative Pain Measurement Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Months 至 23 Months(Child)
性别
Male
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

No opioid

Active Comparator

Acetaminophen every 6 hours and Ibuprofen every 6 hours

干预措施: Acetaminophen, Ibuprofen (Drug)

Opioid

Active Comparator

Acetaminophen every 6 hours, Ibuprofen every 6 hours, and Oxycodone every 6 hours as needed for breakthrough pain for 10 doses.

干预措施: Acetaminophen, Ibuprofen, Oxycodone (Drug)

结局指标

主要结局

Assessment of postop pain measured by Parents Postoperative Pain Measurement Scale

时间窗: 1 year

Assessment of postop pain as measured by Parents Postoperative Pain Measurement Scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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