IV Acetaminophen as an Analgesic Adjunct

Montefiore Medicine Academic Health System

Status and phase

Completed

Phase 4

Conditions

Acute Pain

Treatments

Drug: Normal saline + 0.5 mg IV hydromorphone

Drug: IV acetaminophen + 0.5 mg IV hydromorphone

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02621619

2015-5369

7K23AG033100-07 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

159 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Acute (less than 1 week in duration) severe pain necessitating use of intravenous (IV) opioids in the judgement of the treating attending physician

Exclusion criteria

Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics.
Prior adverse reaction to hydromorphone, morphine, or acetaminophen.
Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
Systolic Blood Pressure (SBP) <100 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
Heart Rate (HR) < 60/min: Opioids can cause bradycardia.
Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
Patients using transdermal pain patches