Phase 4
N=159
IV Acetaminophen as an Analgesic Adjunct
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT02621619 ↗Enrolled (actual)
159
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused — 5.8; 5.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- IV acetaminophen + 0.5 mg IV hydromorphone (Drug); Normal saline + 0.5 mg IV hydromorphone (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused |
5.8; 5.2 | — |
| SECONDARY Change in Pain Intensity Over Time |
3.4; 2.9; 4.7; 4.0; 5.1; 4.8 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02621619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.