NCT02621619

IV Acetaminophen as an Analgesic Adjunct

Randomized Clinical Trial of IV Acetaminophen as an Analgesic Adjunct to IV Hydromorphone in the Treatment of Acute Severe Pain in Elderly ED Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

To determine the efficacy of intravenous (IV) acetaminophen as an analgesic adjunct to IV hydromorphone in the treatment of acute severe pain in the elderly Emergency Department (ED) patients.

Detailed description

A randomized controlled trial to determine the efficacy of 1 gram IV acetaminophen as an analgesic adjunct to 0.5 mg IV hydromorphone in the treatment of acute severe pain in the elderly ED patients.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	IV acetaminophen + 0.5 mg IV hydromorphone	1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone
DRUG	Normal saline + 0.5 mg IV hydromorphone	100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2015-12-03
• Last updated: 2018-11-08
• Results posted: 2018-11-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study