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.
Brief Title
IV Acetaminophen as an Analgesic Adjunct
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Acute Pain
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
* 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
Inclusion 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
* Acute (less than 1 week in duration) severe pain necessitating use of intravenous (IV) opioids in the judgement of the treating attending physician
Gender
All
Gender Based
false
Keywords
Older adults
Elderly
Acute pain
IV acetaminophen
IV hydromorphone
Analgesia
Adjunctive analgesia
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
65 Years
NCT Id
NCT02621619
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2015-5369
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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.
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.
Outcome Measure
Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused
Outcome Time Frame
baseline and 60 minutes after medication was infused
Secondary Ids
Secondary Id
7K23AG033100-07
Secondary Outcomes
Outcome Description
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
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
Outcome Time Frame
baseline to 5 min, 15 min, 30 min, and 45 minutes
Outcome Measure
Change in Pain Intensity Over Time
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
65
Investigators
Investigator Type
Principal Investigator
Investigator Name
Andrew Chang
Investigator Email
achang@montefiore.org
Investigator Phone
achang