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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: IV acetaminophen + 0.5 mg IV hydromorphone; Drug: Normal saline + 0.5 mg IV hydromorphone

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.

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center Moses Division Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IV acetaminophen + 0.5 mg IV hydromorphone; 1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone	Drug: IV acetaminophen + 0.5 mg IV hydromorphone; 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone; Other Names: Ofirmev
Placebo Comparator: Normal saline + 0.5 mg IV hydromorphone; 100 ml normal saline placebo 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; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused	Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). Change in pain intensity is calculated by subtracting pain intensity at 60 minutes from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(60 min)]. Note that a positive change number indicates that pain score decreased after medication was given, while a negative change number indicates that pain score increased after medication was given.	baseline and 60 minutes after medication was infused

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity Over Time	Pain intensity is measured on the numerical rating scale from 0 (no pain) to 10 (worst pain imaginable). Change in pain intensity is calculated by subtracting pain intensity at a later time point from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(15 min)]. Change over time is from baseline to a series of time points: 5 minutes, 15 minutes, 30 minutes, and 45 minutes	baseline to 5 min, 15 min, 30 min, and 45 minutes

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Andrew Chang, MD, MS, Albany Medical College

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: November 21, 2015
• First Submitted That Met QC Criteria: December 1, 2015
• First Posted (Estimate): December 3, 2015

Study Record Updates

• Last Update Posted (Actual): November 8, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Elderly; Analgesia; Older adults; Acute pain; IV acetaminophen; IV hydromorphone; Adjunctive analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Hydromorphone
• Other Study ID Numbers: 2015-5369; 7K23AG033100-07 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes