IV Acetaminophen as an Analgesic Adjunct

NCT02621619 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: 2015-53697K23AG033100-07
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Keywords

Older adults; Elderly; Acute pain; IV acetaminophen; IV hydromorphone; Analgesia; Adjunctive analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Pain Intensity Over Time

  baseline to 5 min, 15 min, 30 min, and 45 minutes

Study Arms (2)

IV acetaminophen + 0.5 mg IV hydromorphone

EXPERIMENTAL

1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone

Drug: IV acetaminophen + 0.5 mg IV hydromorphone

Normal saline + 0.5 mg IV hydromorphone

PLACEBO COMPARATOR

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

Drug: Normal saline + 0.5 mg IV hydromorphone

Interventions

IV acetaminophen + 0.5 mg IV hydromorphone DRUG

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

Also known as: Ofirmev

IV acetaminophen + 0.5 mg IV hydromorphone

Normal saline + 0.5 mg IV hydromorphone DRUG

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

Also known as: Placebo

Normal saline + 0.5 mg IV hydromorphone

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Montefiore Medical Center Moses Division Emergency Department

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Acute Pain; Agnosia

Interventions

Acetaminophen; Hydromorphone; Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Andrew Chang
• Organization: Albany Medical Center

changa1@amc.edu

518-262-0042

Study Officials

• Andrew Chang, MD, MS

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Emergency Medicine

Study Record Dates

• First Submitted: November 21, 2015
• First Posted: December 3, 2015
• Study Start: March 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 8, 2018
• Results First Posted: November 8, 2018

Record last verified: 2018-10

Locations

US (1)