Print

Purpose

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

Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

More Details

Status
Completed
Sponsor
Montefiore Medical Center

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.