Clinical trial NCT02621619: IV Acetaminophen as an Analgesic Adjunct
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pain
Keywords: Older adults
Elderly
Acute pain
IV acetaminophen
IV hydromorphone
Analgesia
Adjunctive analgesia
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2015-12-03
Enrollment: 159
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused
timeFrame: baseline and 60 minutes after medication was infused
Secondary outcomes:
measure: Change in Pain Intensity Over Time
timeFrame: baseline to 5 min, 15 min, 30 min, and 45 minutes
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center Moses Division Emergency Department
state: New York
Study officials:
affiliation: Albany Medical College
name: Andrew Chang, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: