Phase 4
Completed N=159
IV Acetaminophen as an Analgesic Adjunct
Source: ClinicalTrials.gov NCT02621619 ↗Enrolled (actual)
159
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused — 5.8; 5.2 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.