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IV Acetaminophen as an Analgesic Adjunct

This study is currently recruiting participants.
Verified April 2017 by Andrew Chang, Montefiore Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02621619
First Posted: December 3, 2015
Last Update Posted: April 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Andrew Chang, Montefiore Medical Center
  Purpose
To determine the efficacy of IV acetaminophen as an analgesic adjunct to IV hydromorphone in the treatment of acute severe pain in the elderly ED patients.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Andrew Chang, Montefiore Medical Center:

Primary Outcome Measures:
  • Between group difference in before-after numerical rating scale (NRS) pain scores [ Time Frame: 60 minutes ]

Secondary Outcome Measures:
  • Between group difference in before-after numerical rating scale (NRS) pain scores [ Time Frame: 5 min, 15 min, 30 min, and 45 minutes ]
  • Between group difference in proportion who decline additional pain medication when asked [ Time Frame: 60 minutes ]
  • Adverse effects [ Time Frame: 5, 15, 30, 45, and 60 minutes ]
    Between group difference in adverse effects


Estimated Enrollment: 162
Study Start Date: January 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: 0.5 mg IV hydromorphone
Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone
Other Name: Dilaudid
Placebo Comparator: Placebo + 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
Drug: 0.5 mg IV hydromorphone
Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone
Other Name: Dilaudid

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.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Acute (less than 1 week in duration) severe pain necessitating use of 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.
  • SBP <100 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
  • 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 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
  Contacts and Locations
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 Recruiting
The Bronx, New York, United States, 10467
Contact: Andrew Chang, MD, MS    718-920-6626    achang3@yahoo.com   
Principal Investigator: Andrew K Chang, MD, MS         
Sponsors and Collaborators
Montefiore Medical Center
  More Information

Responsible Party: Andrew Chang, Professor of Clinical Emergency Medicine, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02621619     History of Changes
Other Study ID Numbers: 2015-5369
First Submitted: November 21, 2015
First Posted: December 3, 2015
Last Update Posted: April 26, 2017
Last Verified: April 2017

Keywords provided by Andrew Chang, Montefiore Medical Center:
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