IV Acetaminophen as an Analgesic Adjunct

NCT ID: NCT02621619

Last Updated: 2018-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

IV acetaminophen + 0.5 mg IV hydromorphone

1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone

Group Type: EXPERIMENTAL

IV acetaminophen + 0.5 mg IV hydromorphone

Intervention Type: DRUG

1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone

Normal saline + 0.5 mg IV hydromorphone

100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone

Group Type: PLACEBO_COMPARATOR

Normal saline + 0.5 mg IV hydromorphone

Intervention Type: DRUG

100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone

Interventions

IV acetaminophen + 0.5 mg IV hydromorphone

1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone

Intervention Type: DRUG

Normal saline + 0.5 mg IV hydromorphone

100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone

Intervention Type: DRUG

Other Intervention Names

Ofirmev; Placebo

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Andrew Chang, MD

Professor of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Chang, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Albany Medical College

Locations

Montefiore Medical Center Moses Division Emergency Department

The Bronx, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

7K23AG033100-07

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015-5369

Identifier Type: -

Identifier Source: org_study_id