NCT03521102

Acetaminophen Versus IV Hydromorphone for Pain in the Elderly in the ED

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	Acetaminophen 1000mg IV	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
DRUG	Hydromorphone 0.5 mg IV	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

Timeline

• Start date: 2018-08-20
• Primary completion: 2021-10-30
• Completion: 2022-03-23
• First posted: 2018-05-11
• Last updated: 2023-03-02
• Results posted: 2023-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study