Efficacy of acetaminophen with and without oxycodone for analgesia in non-operative treatment of extremity fractures in adults: protocol for a double-blind randomized clinical trial

• Published in: Current controlled trials in cardiovascular medicine 2019-08, Vol.20 (1), p.510-510, Article 510
• Main Authors: Gao, Tao, Zhu, Hongyi, Zhang, Changqing, Chai, Yimin, Guo, Cheng, Zhu, Xiaozhong, Bao, Bingbo, Li, Xingwei, Lin, Junqing, Zheng, Xianyou
• Format: Article
• Language: English
• Subjects: Acetaminophen; Acetaminophen - administration & dosage; Acetaminophen - therapeutic use; Adolescent; Adult; Adults; Aged; Aged, 80 and over; Analgesics; Clinical trials; Double-Blind Method; Double-blind studies; Drug Combinations; Drug overdose; Extremities - injuries; Female; Fracture; Fractures; Fractures, Bone - physiopathology; Fractures, Bone - therapy; Hospitals; Humans; Injuries; Male; Middle Aged; Narcotics; Non-operative treatment; Objectives; Older people; Opioids; Outcome Assessment, Health Care; Oxycodone - therapeutic use; Pain management; Pain Management - methods; Randomized Controlled Trials as Topic; Study Protocol; Young Adult
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-019-3579-x

Opioids and acetaminophen are both widely used to relieve pain after non-operative treatment of limb fractures, but evidence for the superiority of opioids versus acetaminophen is lacking. In this study, we aim to determine whether acetaminophen is non-inferior to the acetaminophen/oxycodone combination for pain relief after non-operative fixation of an extremity limb fracture. We hypothesize that acetaminophen is non-inferior to the acetaminophen/oxycodone combination. A double-blind randomized controlled trial will be conducted. Power analysis determined that 1226 participants will be needed (P