drugset / Trial / NCT01429298

Comparing Intravenous Hydromorphone to Usual Care

NCT01429298 ↗

Phase 4 Completed 350 enrolled Montefiore Medical Center
RandomizedParallel-groupSingle-blindTreatment

Summary

In this randomized controlled trial, 2 mg intravenous (IV) hydromorphone will be more efficacious than usual care (usual care is analgesic management according to the judgment of the attending physician caring for that patient) in emergency department (ED) patients aged 21-64 years. The primary efficacy outcomes are the proportion of patients in each arm who choose to forgo additional pain medication in 30 minutes of entry into the study and the change in numerical rating scale (NRS) pain scores from baseline to 30 minutes post baseline.

Timeline

Start
2010-03
Primary completion
2010-11
Completion
2010-11

Outcome

Met primary endpoint

paper 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. PMID 23406078 ↗

paper This difference of 11.6% was statistically and clinically significant (95% confidence interval [CI] = 1.8% to 21.1%). PMID 23406078 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydromorphone Other / unclassified 2 mg Intravenous

Indications

No indication recorded.