跳至主要内容
临床试验/NCT06187584
NCT06187584已完成4 期

Nonopioid Versus Opioid Outpatient Pain Management Following Surgical Fixation of Gartland Type III Supracondylar Humerus Fractures in Children: A Prospective, Randomized Study

Children's Mercy Hospital Kansas City1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2019年4月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
137
试验地点
1
主要终点
Subject Reported Pain Level Using the Wong-Baker Faces Pain Scale.

研究概览

简要总结

This purpose of this study is to determine the efficacy of nonopioid versus opioid analgesic regimens following surgical fixation of Gartland Type III Supracondylar Humoral Fractures (SCHFs) to assist in the development of a standard outpatient pain management regimen in the treatment of these injuries.

详细描述

Pain is variably managed in pediatric populations, particularly in the postoperative outpatient setting. The lack of data describing and supporting the safety and efficacy of the use of analgesic drugs in children is a major contributor to this problem. Postoperative prescription opioids have been associated with high rates of morbidity and mortality in children and identified as a pathway to future opioid abuse. With increasing public awareness regarding these issues surrounding opioid use and no evidence to support superior treatment outcomes in children with the use of opioids, there is a pressing need for data to guide healthcare providers in choosing analgesic drugs to treat postoperative pain in pediatric patients.

Prior studies have evaluated the use of nonopioid versus opioid analgesic drugs in the outpatient setting following pediatric ambulatory surgery. These studies found nonopioid analgesics, such as acetaminophen and ibuprofen, to be as equally effective as opioid analgesics, including morphine, codeine and oxycodone. Further, the use of nonopioid analgesics was associated with significantly fewer side effects. These findings imply that nonopioid analgesics may be a superior initial therapy following ambulatory surgery.

However, no study has evaluated the use of nonopioid versus opioid analgesic regimens in the outpatient setting following surgical fixation of supracondylar humerus fractures (SCHFS). SCHFs are the second most common fracture in children, often requiring urgent surgical intervention. Despite their frequency, there is no standard for postoperative outpatient pain management in the treatment of these injuries.

Almost all SCHFs can be described according to the Gartland classification. The Gartland classification delineates three types of SCHFs. Gartland type I fractures are nondisplaced and do not require surgical intervention, while Gartland type II fractures are angulated, but maintain an intact posterior cortex. These may or may not require surgical intervention. However, Gartland type III fractures are completely displaced with no posterior cortical contact and require surgical intervention with either closed reduction and percutaneous pinning (CRPP) or open reduction with percutaneous pinning (ORPP). This study will look at only Gartland type III SCHFs because they necessitate surgical intervention, most commonly CRPP.

Investigators hypothesize that there is no difference in daily pain levels for nonopioid analgesic regimens compared to opioid analgesic regimens in management of post-operative pain in the outpatient period following surgical fixation of Gartland type III supracondylar humerus fracture in children.

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
5 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients presenting to Children's Mercy Hospital
  • Patients 48-119 months of age
  • Closed and completely displaced Gartland type III SCHFs (ICD-10 codes: S42.411A, S42.412A and S42.413A)

排除标准

  • Patients younger than 48 months of age or older than 120 months of age
  • Nondisplaced SCHFs (ICD-10): S42.414-, S42.415- and S42.416-)
  • Open and completely displaced Gartland type III SCHFs (ICD-10: S42.411B, S42.412B and S42.413B)
  • Injury requiring open reduction and/or vascular injury requiring treatment
  • Patients presenting with additional injuries
  • Patients with known allergy to medications used in this study
  • Patients receiving regular treatment with opioids or NSAIDs
  • Patients with underlying medical issues affecting cognitive status
  • Patients with hepatic, gastrointestinal, renal or hematologic disease/disorders
  • Children that are wards of the state, prisoners or of CM employees
  • Non-English speaking families
  • Patients not admitted before and after surgery
  • Fractures not surgically treated within 18 hours of injury
  • Use of local anesthetic at surgical site

研究组 & 干预措施

Control Group (opioid group)

Active Comparator

Hydrocodone/acetaminophen 0.15mg/kg by mouth (PO) every (q) 6 hours as needed (PRN) with ibuprofen 10mg/kg PO q6 hours PRN

干预措施: Hydrocodone/acetaminophen (Drug)

Control Group (opioid group)

Active Comparator

Hydrocodone/acetaminophen 0.15mg/kg by mouth (PO) every (q) 6 hours as needed (PRN) with ibuprofen 10mg/kg PO q6 hours PRN

干预措施: Ibuprofen (Drug)

Experimental Group (nonopioid group):

Experimental

Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours

干预措施: Acetaminophen (Drug)

Experimental Group (nonopioid group):

Experimental

Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours

干预措施: Ibuprofen (Drug)

结局指标

主要结局

Subject Reported Pain Level Using the Wong-Baker Faces Pain Scale.

时间窗: At the relative same time each day at time of discharge (baseline) and postoperative days 1-5 (i.e., five follow-up measures).

The subject reported pain level using the scale 0-10, with 0 being no pain and 10 being worst pain, will be measured at the time of discharge (i.e., baseline measure) and once daily at the relative same time each day on postoperative days 1-5. Thus, subjects may have up to a total of six pain level measurements. Higher scores mean a worse outcome.

次要结局

  • Side Effects From Medication(First follow up visit, occurring approximately one week postoperatively.)
  • Number of Days of Medication Usage(First follow up visit, occurring approximately one week postoperatively.)
  • Parent Satisfaction With (Subject) Child's Pain Control(Two hours post intervention and everyday at the same time as the initial response for five consecutive days post intervention)
  • Use of Medication(s) Other Than Those Indicated by Their Physician to Control Pain(First follow up visit, occurring approximately one week postoperatively.)
  • Number of Calls to a Healthcare Provider for Breakthrough Pain Rescue(First follow up visit, occurring approximately one week postoperatively.)
  • Number of Visits to a Healthcare Provider for Breakthrough Pain Rescue(First follow up visit, occurring approximately one week postoperatively.)
  • Daily Use of Opioid or Nonopioid Medicine on Postoperative Days 1-5(Postoperative days 1-5)
  • Participant's Overall Pain Control(First follow up visit, occurring approximately one week postoperatively.)
  • Overall Parent Satisfaction(First follow up visit, occurring approximately one week postoperatively.)

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Caleb Grote

Physician, MD/PhD

Children's Mercy Hospital Kansas City

研究点 (1)

Loading locations...

相似试验