IV Acetaminophen as an Analgesic Adjunct

Phase 4

Completed

Interventions: Drug: Normal saline + 0.5 mg IV hydromorphone
Drug: IV acetaminophen + 0.5 mg IV hydromorphone

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Normal saline + 0.5 mg IV hydromorphone	Normal saline + 0.5 mg IV hydromorphone	100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone
IV acetaminophen + 0.5 mg IV hydromorphone	IV acetaminophen + 0.5 mg IV hydromorphone	1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone

Primary Outcome Measures

Name	Time	Method
Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused	baseline and 60 minutes after medication was 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.

Secondary Outcome Measures

Name	Time	Method
Change in Pain Intensity Over Time	baseline to 5 min, 15 min, 30 min, and 45 minutes	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