Our hypothesis that oxycodone/acetaminophen provides analgesia superior to codeine/acetaminophen was rejected. Although pain within each group was reduced by more than half, the between-group difference was not significant. Pending independent validation, these unexpected findings suggest that codeine/acetaminophen, a Schedule III agent, may be a clinically reasonable outpatient opioid alternative to oxycodone/acetaminophen, a more tightly restricted Schedule II agent thought to be more prone to misuse.
Objectives: The objective was to test the efficacy and safety of 2 mg of intravenous (IV) hydromorphone (Dilaudid) against "usual care" in emergency department (ED) patients with acute severe pain.Methods: This was a randomized clinical trial. Patients allocated to 2 mg of IV hydromorphone received their medication in a single dose. Those randomized to usual care received any IV opioid, with type, dose, and frequency chosen by the ED attending. All patients received 2 L/min. nasal cannula oxygen. The primary outcome was the difference in the proportion of patients who achieved clinically satisfactory analgesia by 30 minutes. This was defined as the patient declining additional analgesia when asked the question, "Do you want more pain medicine?" A 10% absolute difference was chosen a priori as the minimum difference considered clinically significant.Results: Of 175 subjects randomized to each group, 164 in the 2 mg hydromorphone group and 161 in the usual care group had sufficient data for analysis. Additional pain medication was declined by 77.4% of patients in the 2 mg hydromorphone group at 30 minutes, compared to 65.8% in the usual care group. This difference of 11.6% was statistically and clinically significant (95% confidence interval [CI] = 1.8% to 21.1%). Safety profiles were similar and no patient required naloxone. There was more pruritus in the hydromorphone group (18.3% vs. 8.7%; difference = 9.6%, 95% CI = 2.6% to 16.6%).Conclusions: Using a simple dichotomous patient-centered endpoint in which a difference of 10% in proportion obtaining adequate analgesia was considered clinically significant, 2 mg of hydromorphone in a single IV dose is clinically and statistically more efficacious when compared to usual care for acute pain management in the ED.ACADEMIC EMERGENCY MEDICINE 2013; 20:185-192
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