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IV Acetaminophen as an Analgesic Adjunct

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ClinicalTrials.gov Identifier: NCT02621619
Recruitment Status : Completed
First Posted : December 3, 2015
Results First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Andrew Chang, MD, Albany Medical College

Tracking Information
First Submitted Date  ICMJE November 21, 2015
First Posted Date  ICMJE December 3, 2015
Results First Submitted Date  ICMJE September 14, 2018
Results First Posted Date  ICMJE November 8, 2018
Last Update Posted Date November 8, 2018
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2018)
Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2015)
Between group difference in before-after numerical rating scale (NRS) pain scores [ Time Frame: 60 minutes ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2018)
Change in Pain Intensity Over Time [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2015)
  • Between group difference in before-after numerical rating scale (NRS) pain scores [ Time Frame: 5 min, 15 min, 30 min, and 45 minutes ]
  • Between group difference in proportion who decline additional pain medication when asked [ Time Frame: 60 minutes ]
  • Adverse effects [ Time Frame: 5, 15, 30, 45, and 60 minutes ]
    Between group difference in adverse effects
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IV Acetaminophen as an Analgesic Adjunct
Official Title  ICMJE Randomized Clinical Trial of IV Acetaminophen as an Analgesic Adjunct to IV Hydromorphone in the Treatment of Acute Severe Pain in Elderly ED Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Pain
Intervention  ICMJE
  • Drug: IV acetaminophen + 0.5 mg IV hydromorphone
    1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone
    Other Name: Ofirmev
  • Drug: Normal saline + 0.5 mg IV hydromorphone
    100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: IV acetaminophen + 0.5 mg IV hydromorphone
    1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone
    Intervention: Drug: IV acetaminophen + 0.5 mg IV hydromorphone
  • Placebo Comparator: Normal saline + 0.5 mg IV hydromorphone
    100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone
    Intervention: Drug: Normal saline + 0.5 mg IV hydromorphone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2018)
159
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2015)
162
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02621619
Other Study ID Numbers  ICMJE 2015-5369
7K23AG033100-07 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrew Chang, MD, Albany Medical College
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Andrew Chang, MD, MS Albany Medical College
PRS Account Montefiore Medical Center
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP