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Completed

NCT Number: NCT02621619

IV Acetaminophen as an Analgesic Adjunct

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore Medical Center Moses Division Emergency Department

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV acetaminophen + 0.5 mg IV hydromorphone

Drug

1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone

Other names: Ofirmev

Normal saline + 0.5 mg IV hydromorphone

Drug

100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone

Other names: Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 3, 2015
Registry last updated
Nov 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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