Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture: A Prospective, Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Oxycodone Tablets Used for Breakthrough Pain.
研究概览
简要总结
Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, are excellent medications for providing pain control in certain patients. There is some data to suggest that NSAIDs can be used to reduce postoperative pain and narcotic use in patients who had undergone carpal tunnel release. There are mixed results about the effect of bone healing in adult patients with broken bones. The investigators hypothesize that NSAID administration in the acute phase of distal radius fracture healing will be non-inferior for pain control and decrease the use of opioid analgesics compared to patients who take acetaminophen for pain control during this same time period. Furthermore, the investigators hypothesize that patients will have similar or better patient reported outcomes, range of motion, and strength with the administration of NSAIDs.
详细描述
In the United States, drug overdose deaths and opioid-involved deaths continue to increase, quadrupling since 1999; six out of ten drug overdose deaths involve an opioid. Overdoses from prescription opioids are a driving factor in the 15-year increase in opioid overdose deaths. The amount of prescription opioids sold to pharmacies, hospitals, and doctors' offices has drastically risen, yet there had not been an overall change in the amount of pain that Americans reported. Deaths from prescription opioids-drugs like oxycodone, hydrocodone, and methadone-have more than quadrupled since 1999.
Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to control both postoperative pain and pain associated with some orthopaedic injuries in children and adults with certain orthopaedic injuries. Further, the use of NSAIDs for pain control has been shown to lessen the use of narcotic pain medications, the adverse effects of which are well known. With the current opioid epidemic, more research is needed to determine strategies to reduce opioid use in patients with orthopaedic injuries. Chapman et al. showed that NSAIDs can be used effectively to reduce postoperative pain and narcotic use in patients who had undergone carpal tunnel release. Although distal radius fractures are one of the most common fractures, no studies have examined the effect of NSAIDs on distal radius fracture pain. The purpose of this study is to compare pain and narcotic pain medication use in patients who have had distal radius fractures in patients who use NSAIDs to those who do not.
To the authors' knowledge, there have been no clinical prospective, randomized studies to evaluate the effect that NSAIDs have on patients with distal radius fractures. The investigators hypothesize that NSAID administration in the acute phase of distal radius fracture healing will be non-inferior for pain control and decrease the use of opioid analgesics compared to patients who take acetaminophen for pain control during this same time period. Furthermore, the investigators hypothesize that patients will have similar or better patient reported outcomes, range of motion, and strength with the administration of NSAIDs.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Distal radius fracture
排除标准
- •Contraindication to NSAID use (cannot tolerate, gastritis, ulcers, chronic kidney disease stage 4 or higher, bleeding disorders/thrombocytopenia)
- •Inability to take breakthrough medications
- •Regular use of NSAIDs
- •Regular use of Narcotics
- •Open fracture
- •Other orthopaedic injuries (polytrauma)
- •Pathologic fracture
- •Previous injury to the bone
- •Pregnant or plan to become pregnant
- •Unable to sign informed consent
研究组 & 干预措施
Acetaminophen
Acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day.
Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.
干预措施: Acetaminophen (Drug)
NSAID
NSAID administered ibuprofen 400-800 mg, up to three times a day and acetaminophen with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day as needed for pain control.
Oxycodone 5mg 1-2 tablets q4-6 hours will be available for breakthrough pain.
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Number of Oxycodone Tablets Used for Breakthrough Pain.
时间窗: 2 weeks
The number and dosing of oxycodone tablets taken per participant for breakthrough pain will be recorded.
Intensity of Pain: Visual Analog Scale (VAS)
时间窗: 2 Week, 6 Week, 3 Month, 6 Month and 1 Year Post Surgery
The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
Fractures Fully Healed
时间窗: 6 weeks post surgery
Radiographic evidence of boney healing of the distal radius. This outcome measure is reported as the number of participants in each group with fully healed fractures at the designated time point.
次要结局
- QuickDASH(2 Week, 6 Week, 3 Month, 6 Month and 1 Year Post Surgery)
- Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity)(2 Weeks, 6 Weeks, 3 Months, 6 Months and 1 Year post surgery)
- Grip Strength(2 Week, 6 Week and 3 Month Post Surgery)
- Key Pinch Strength(2 weeks, 6 weeks, and 3 months post surgery)
- Wrist Range of Motion (ROM)(2 weeks, 6 weeks and 3 months post surgery)
研究者
Daniel London
Assistant Professor, Orthopedic Surgery
University of Missouri-Columbia