CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 162 enrolled
Drug / intervention
Acetaminophen 1000mg IV +1 moredrug
Likely dose
Acetaminophen 1000mg IVfrom 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/NCT03521102
NCT03521102Phase 2Completed

An ED-based Randomized Trial of IV Acetaminophen Versus IV Hydromorphone for Elderly Adults With Acute Severe Pain

Montefiore Medical Center·interventional·Posted May 11, 2018·Updated Mar 2, 2023

In Brief

A Phase 2 clinical trial evaluating Acetaminophen 1000mg IV and Hydromorphone 0.5 mg IV for Acute Pain. Completed, enrolled 162 participants across 1 site.

Detailed Summary

Intravenous opioids are the mainstay of acute, severe pain treatment in Emergency Departments (ED) across the country. Acetaminophen, given orally, has also been used for treatment of mild to moderate pain. The more potent intravenous (IV) form of acetaminophen has been widely used in Europe for more than 20 years as post-surgical analgesia and received full FDA approval in the USA in 2010. As part of a continuing set of studies whose goal is to optimize treatment of pain among elderly ED patients, this randomized study will compare efficacy and safety of IV acetaminophen to IV hydromorphone.

Study Details

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

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 11, 2018
Enrollment StartAug 20, 2018
Primary CompletionOct 30, 2021
Study CompletionMar 23, 2022
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 8.1 years ago

Interventions

Acetaminophen 1000mg IVdrug

1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push

Hydromorphone 0.5 mg IVdrug

100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in 2ml of normal saline, administered as a slow intravenous push