CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 215 enrolled
Drug / intervention
Hydromorphonedrug
Likely dose
Not stated in 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/NCT01892709
NCT01892709Phase 4Completed

Efficacy of an Acute Pain Titration Protocol Driven by Patient Response to a Simple Query: Do You Want More Pain Medication?

Montefiore Medical Center·interventional·Posted Jul 4, 2013·Updated May 31, 2023

In Brief

A Phase 4 clinical trial evaluating Hydromorphone for Acute Severe Pain. Completed, enrolled 215 participants across 1 site.

Detailed Summary

This is an exploratory, hypothesis-generating safety and efficacy study for patients who come to the ER in acute (less than 7 days in duration) severe pain. Patients with chronic pain will not be enrolled. Eligible patients will receive up to a maximum of 4 mg IV hydromorphone over a 4 hour period. Hydromorphone will be given as 1 mg increments based on how the patient responds to the question, "Do you want more pain medicine?". This question will be asked repeatedly 30 minutes after the patient answers "no" or 30 minutes after the most recent dose of IV hydromorphone (which occurs if the patient answers "yes"). Up to 10% (approximately 30 patients) will serve as a pilot at the start of the study.

Study Details

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

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 4, 2013
Enrollment StartJun 1, 2013
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.0 years ago

Interventions

Hydromorphonedrug