The between-group difference of the primary outcome was not statistically significant (−0.50 P = .11) despite a 6-fold increased dose of opioids being delivered in the strong opioid group.Ĭonclusions and Relevance This study found that treatment with strong opioid medication subacutely was not superior to treatment with milder medication for treatment of pain among patients with surgically managed orthopedic fractures. From days 1 to 7 postdischarge, the mean daily NRS mean pain score was 4.04 (95% Cl, 3.67 to 4.41) in the strong opioid group and 4.54 (95% Cl, 4.17 to 4.90) in the mild opioid group. Results A total of 120 patients with 1 or more acute orthopedic fractures requiring surgical fixation were randomized, including 59 patients in the strong-opioid group (43 men mean age, 36.0 years mean oral morphine equivalent for days 1-7 of 32.9 mg) and 61 patients in the mild opioid group (47 men mean age, 38.2 years mean oral morphine equivalent for days 1-7 of 5.5 mg). The key secondary outcomes were EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) responses, worst pain, medication adverse events, global perceived effect, and return to work. Participants were asked to rate their mean pain over the previous 24 hours daily using an NRS score from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable. Main Outcomes and Measures The primary outcome was the mean of daily pain scores collected during week 1 of treatment measured using the Numerical Pain Rating Scale (NRS). Interventions Initiation at discharge of oxycodone hydrochloride 5 mg of 10 mg (ie, 1 or 2 tablets) or combination acetaminophen and codeine 500 mg and 8 mg or 1000 mg and 16 mg (ie, 1 or 2 tablets) 4 times daily for a maximum duration of 3 weeks. Data were analyzed from June through October 2018. Participants were inpatients who had sustained an acute nonpathological facture of a long bone or the pelvis, patella, calcaneus, or talus who were treated with surgical fixation and enrolled from July 27, 2016, to August 22, 2017. Objective To test the hypothesis that strong opioids provide greater analgesia than mild opioids over the first week postdischarge from hospital after fracture surgical treatment.ĭesign, Setting, and Participants This double-blind, superiority, randomized clinical trial was conducted at a single-center, major trauma hospital in Sydney, Australia. Importance Patients with a surgically managed fracture are commonly discharged from the hospital with a strong opioid prescription, but limited evidence exists to support this practice. Shared Decision Making and Communication. Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.Clinical Implications of Basic Neuroscience.Challenges in Clinical Electrocardiography.
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