Bronx, New York 10467


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.


Study summary:

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.


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


NCT ID:

NCT02621619


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Bronx, New York 10467
United States

Andrew Chang, MD, MS
Phone: 718-920-6626
Email: achang3@yahoo.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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