IV Acetaminophen as an Analgesic Adjunct

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Clinical Trial of IV Acetaminophen as an Analgesic Adjunct to IV Hydromorphone in the Treatment of Acute Severe Pain in Elderly ED Patients

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: IV acetaminophen + 0.5 mg IV hydromorphone
* Drug: Normal saline + 0.5 mg IV hydromorphone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV acetaminophen + 0.5 mg IV hydromorphone<br>1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone | Drug: IV acetaminophen + 0.5 mg IV hydromorphone<br>* 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone<br>* Other names: Ofirmev;|
| Placebo Comparator: Normal saline + 0.5 mg IV hydromorphone<br>100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone | Drug: Normal saline + 0.5 mg IV hydromorphone<br>* 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused | Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). Change in pain intensity is calculated by subtracting pain intensity at 60 minutes from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(60 min)]. Note that a positive change number indicates that pain score decreased after medication was given, while a negative change number indicates that pain score increased after medication was given. | baseline and 60 minutes after medication was infused | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Intensity Over Time | Pain intensity is measured on the numerical rating scale from 0 (no pain) to 10 (worst pain imaginable). Change in pain intensity is calculated by subtracting pain intensity at a later time point from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(15 min)]. Change over time is from baseline to a series of time points: 5 minutes, 15 minutes, 30 minutes, and 45 minutes | baseline to 5 min, 15 min, 30 min, and 45 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older adults, Elderly, Acute pain, IV acetaminophen, IV hydromorphone, Analgesia, Adjunctive analgesia