title: 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.
abstract: OBJECTIVE
  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.
authors: Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA. ACHANG@montefiore.org
authors: Andrew K
authors: AK
authors: Chang
authors: Polly E
authors: PE
authors: Bijur
authors: Jason B
authors: JB
authors: Lupow
authors: E
authors: E
authors: John Gallagher
mesh_terms: D059787:Acute Pain / Q000188:drug therapy*; D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D004091:Hydromorphone / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D004091:Hydromorphone