CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 230 enrolled
Drug / intervention
Hydromorphonedrug
Likely dose
Hydromorphone 1mgfrom 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/NCT00682435
NCT00682435Phase 4Completed

Safety and Speed of Onsent of Intravenous Hydromorphone Using Incremental 1mg Doses up to 2mg in the Treatment of Adult ED Patients With Moderate to Severe Pain

Montefiore Medical Center·interventional·Posted May 22, 2008·Updated Aug 13, 2018

In Brief

A Phase 4 clinical trial evaluating Hydromorphone for Pain. Completed, enrolled 230 participants across 1 site.

Detailed Summary

We wish to examine the safety and speed of onset of giving a dose of 1mg hydromorphone followed by an additional 1mg. Eligible patients will be given 1 mg intravenous (IV) hydromorphone. At 15 minutes, these patients will be asked the question, "Do you need more pain medication?" Those that answer "yes" will receive an additional 1mg IV hydromorphone. Those that answer "no" will not receive additional pain medications at that time period (15 minutes). Thus, we wish to give up to 2 mg IV hydromorphone titrated to patients' pain, which we believe will result in less incidence of oxygen desaturation. If our study shows that this regimen is safe, its efficacy can be assessed in future trials. Positive results of those trials may lead to the use of this regimen to improve pain management in the emergency department.

Study Details

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

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 22, 2008
Enrollment StartAug 1, 2007
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 18.1 years ago

Interventions

Hydromorphonedrug

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