Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
The purpose of this study is to evaluate two drug options for pain control in patients following wrist injury. Participants will be randomized to one of the 2 pain relief treatments to determine what treatment provides the most effective pain relief
详细描述
The purposes of this noninferiority randomized clinical trial are to determine whether: 1. the most commonly used non-narcotic analgesic (ibuprofen 600 mg + acetaminophen 500 mg) provides pain relief that is not unacceptably worse than the most commonly prescribed narcotic (hydrocodone 5 mg + acetaminophen 500 mg) in patients with a hand or wrist fracture. 2. the following covariates affect pain outcomes: sex/gender, age, gender-related pain expectations, paid/unpaid work roles, comorbid health status, baseline pain intensity, and employment status.
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
- Double (Participant, Investigator)
盲法说明
study medication will be masked to participant and investigator. Medication will be dispensed by pharmacy in identical blister packs
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients 18 and older undergoing non-operative management of a hand or wrist fracture will be considered eligible.
- •Able to read and speak English
排除标准
- •pain exceeding 7/10 on numeric rating scale or 35/50 on PRWE pain scale at enrollment
- •nerve injury
- •surgeon decision that surgery is required
- •history of chronic opioid use
- •documented or suspected substance abuse
- •individuals currently on daily use of ibuprofen, acetaminophen or other pain-altering medication including medications like Neurontin (gabapentin) and Ultram (tramadol)
- •individuals with documented or suspected chronic pain syndrome, reported allergy or adverse reaction to hydrocodone, acetaminophen, or ibuprofen
- •history or symptoms of serious medical problem in the last year (i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver disease, renal disease)
- •patients with active peptic ulcer disease (history of severe heartburn)
- •symptoms of infection
- •pregnant or lactating women
- •diagnosis of cognitive impairment
- •unable to provide informed consent
- •unable or unwilling to fill out the forms
- •prior fracture in same hand
- •on Coumadin or Plavix
- •other medical or psychological health conditions that preclude them from receiving either intervention
- •or unable to return for follow-up visits
研究组 & 干预措施
Narcotic
Hydrocodone 5mg/Acetaminophen 500 mg Tab
干预措施: Acetaminophen 500Mg Tab (Drug)
Narcotic
Hydrocodone 5mg/Acetaminophen 500 mg Tab
干预措施: Ibuprofen 600 mg tab (Drug)
Non Narcotic
Ibuprofen 600mg Tab + acetaminophen 500 mg Tab
干预措施: Hydrocodone 5Mg/Acetaminophen 500Mg Tab (Drug)
结局指标
主要结局
Pain
时间窗: 0-2 weeks
PRWE (patient rated wrist evaluation) 1. Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 2. Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0
次要结局
- Pain diary(2 weeks)
- Grip strength(24 weeks)
- Dexterity(12 and 24 weeks)
- Adverse events(24 weeks)
- Drug use(2 weeks)
- Pinch strength(24 weeks)
- Range of Motion(12 and 24 weeks)
- pain management(3 weeks)
- Work Impact(12 and 24 weeks)
- Future preference(24 weeks)