CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 350 enrolled
Drug / intervention
Hydromorphone +1 moredrug
Likely dose
Hydromorphone 1 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/NCT00825370
NCT00825370Phase 3Completed
CompareCT.gov

Protocolized vs Discretionary Use of Opioids in Acute Pain

Montefiore Medical Center·interventional·Posted Jan 21, 2009·Updated Jun 12, 2018

In Brief

A Phase 3 clinical trial evaluating Hydromorphone and IV opioid for Pain. Completed, enrolled 350 participants across 1 site.

Detailed Summary

We are testing whether patients who received protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg Intravenous (IV) hydromorphone 15 minutes later if the patients wants more) will have better pain relief and no more adverse events than patients receiving discretionary care, in which the patients receives whatever IV opioid the treating physician wants to give, in whatever dose.

Study Details

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

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 21, 2009
Enrollment StartOct 1, 2008
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.4 years ago

Interventions

Hydromorphonedrug

1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later

IV opioiddrug

Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.