CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 350 enrolled
Drug / intervention
Hydromorphone +1 moredrug
Likely dose
Hydromorphone 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01429298
NCT01429298Phase 4Completed
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Randomized Clinical Trial Comparing Intravenous Hydromorphone to Usual Care

Montefiore Medical Center·interventional·Posted Sep 7, 2011·Updated May 18, 2018

In Brief

A Phase 4 clinical trial evaluating Hydromorphone and Usual care for Pain. Completed, enrolled 350 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 7, 2011
Enrollment StartMar 1, 2010
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.8 years ago

Interventions

Hydromorphonedrug

2 mg IV hydromorphone over to 2-3 minutes

Usual caredrug

Attending administers IV opioid of his choosing