Randomized Clinical Trial of Efficacy and Safety of a Single 2‐mg Intravenous Dose of Hydromorphone Versus Usual Care in the Management of Acute Pain

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. Resumen Ensayo Clínico Aleatorizado de la Eficacia y la Seguridad de una Dosis Única de 2 mg de Hidromorfona Frente a la Atención Estándar en el Manejo del Dolor Agudo Objetivos Determinar la eficacia y la seguridad de 2 mg de hidromorfona (Dilaudid) intravenosa (IV) frente a la atención estándar en los pacientes con dolor agudo grave en el servicio de urgencias (SU). Metodología Se trata de un ensayo clínico aleatorizado. Los pacientes asignados a 2 mg de hidromorfona IV recibieron la medicación en una dosis única. Aquéllos asignados a la atención estándar recibieron cualquier opioide intravenoso, con tipo, dosis y frecuencia elegidos por el médico del SU. Todos los pacientes recibieron oxígeno en gaf