Overview

IV Acetaminophen as an Analgesic Adjunct

Status:
Completed
Trial end date:
2017-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Montefiore Medical Center
Collaborator:
National Institute on Aging (NIA)
Treatments:
Acetaminophen
Analgesics
Hydromorphone
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