Back to resultsIV Acetaminophen as an Analgesic Adjunct
Primary Purpose
Acute Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV acetaminophen + 0.5 mg IV hydromorphone
Normal saline + 0.5 mg IV hydromorphone
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring Older adults, Elderly, Acute pain, IV acetaminophen, IV hydromorphone, Analgesia, Adjunctive analgesia
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
Sites / Locations
- Montefiore Medical Center Moses Division Emergency Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
IV acetaminophen + 0.5 mg IV hydromorphone
Normal saline + 0.5 mg IV hydromorphone
Arm Description
1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone
100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02621619
First Posted
November 21, 2015
Last Updated
October 10, 2018
Sponsor
Montefiore Medical Center
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT02621619
Brief Title
IV Acetaminophen as an Analgesic Adjunct
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
Older adults, Elderly, Acute pain, IV acetaminophen, IV hydromorphone, Analgesia, Adjunctive analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV acetaminophen + 0.5 mg IV hydromorphone
Arm Type
Experimental
Arm Description
1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone
Arm Title
Normal saline + 0.5 mg IV hydromorphone
Arm Type
Placebo Comparator
Arm Description
100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone
Intervention Type
Drug
Intervention Name(s)
IV acetaminophen + 0.5 mg IV hydromorphone
Other Intervention Name(s)
Ofirmev
Intervention Description
1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone
Intervention Type
Drug
Intervention Name(s)
Normal saline + 0.5 mg IV hydromorphone
Other Intervention Name(s)
Placebo
Intervention Description
100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone
Primary Outcome Measure Information:
Title
Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused
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.
Time Frame
baseline and 60 minutes after medication was infused
Secondary Outcome Measure Information:
Title
Change in Pain Intensity Over Time
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
Time Frame
baseline to 5 min, 15 min, 30 min, and 45 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Chang, MD, MS
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center Moses Division Emergency Department
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
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IV Acetaminophen as an Analgesic Adjunct
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