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IV Acetaminophen as an Analgesic Adjunct

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ClinicalTrials.gov Identifier: NCT02621619
Recruitment Status : Completed
First Posted : December 3, 2015
Results First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Andrew Chang, MD, Albany Medical College

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.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: IV acetaminophen + 0.5 mg IV hydromorphone Drug: Normal saline + 0.5 mg IV hydromorphone Phase 4

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  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of IV Acetaminophen as an Analgesic Adjunct to IV Hydromorphone in the Treatment of Acute Severe Pain in Elderly ED Patients
Actual Study Start Date : March 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Placebo




Primary Outcome Measures :
  1. Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused [ Time Frame: baseline and 60 minutes after medication was 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.



Secondary Outcome Measures :
  1. Change in Pain Intensity Over Time [ Time Frame: baseline to 5 min, 15 min, 30 min, and 45 minutes ]

    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




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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02621619


Locations
United States, New York
Montefiore Medical Center Moses Division Emergency Department
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
National Institute on Aging (NIA)
Investigators
Principal Investigator: Andrew Chang, MD, MS Albany Medical College
  Study Documents (Full-Text)

Documents provided by Andrew Chang, MD, Albany Medical College:

Responsible Party: Andrew Chang, MD, Professor of Emergency Medicine, Albany Medical College
ClinicalTrials.gov Identifier: NCT02621619     History of Changes
Other Study ID Numbers: 2015-5369
7K23AG033100-07 ( U.S. NIH Grant/Contract )
First Posted: December 3, 2015    Key Record Dates
Results First Posted: November 8, 2018
Last Update Posted: November 8, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Andrew Chang, MD, Albany Medical College:
Older adults
Elderly
Acute pain
IV acetaminophen
IV hydromorphone
Analgesia
Adjunctive analgesia

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Analgesics
Hydromorphone
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants