CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 350 enrolled
Drug / intervention
H2O +1 moredrug
Likely dose
H2O 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/NCT01311895
NCT01311895Phase 3Completed
CompareCT.gov

Randomized Clinical Trial Comparing Two Protocols Using IV Hydromorphone

Montefiore Medical Center·interventional·Posted Mar 10, 2011·Updated May 18, 2018

In Brief

A Phase 3 clinical trial evaluating H2O and 1+1 for Acute Pain. Completed, enrolled 350 participants across 1 site.

Detailed Summary

The purpose of this study is to compare two opioid protocols ("H2O" and "1+1") for the treatment of acute severe pain in the emergency department. The investigators primary hypothesis is that the "H2O" protocol will be more efficacious than the "1+1" protocol in Emergency Department patients aged 21-64 years. The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pain
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 10, 2011
Enrollment StartJan 1, 2011
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.3 years ago

Interventions

H2Odrug

2 mg IV hydromorphone

1+1drug

1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"