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Completed

NCT Number: NCT03107481

Acetaminophen IV vs Hydromorphone IV in the ED

The purpose of the current study is to compare the analgesic efficacy of intravenous acetaminophen and intravenous hydromorphone in the treatment of acute pain in the ED.

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Key information

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

This is a randomized, double-blind placebo-controlled clinical trial comparing intravenous acetaminophen and intravenous hydromorphone in the treatment of acute pain in the Emergency Department. Enrolled subjects presenting to the ED with acute pain will be randomized to receive either acetaminophen 1g IV or hydromorphone 1mg IV.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 21 through 64 years of age: This is a study of adult ED patients.
  • Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in the ED literature.
  • ED attending physician's judgment that the patient's pain warrants IV opioids.
  • ED attending physician's judgment that the patient has capacity to provide informed consent.
  • Patients must be able to understand English or Spanish.

Exclusion criteria

  • Use of opioids or tramadol within past 24 hours.
  • Use of acetaminophen or non-steroidal anti-inflammatory medication within the previous 8 hours.
  • Prior adverse reaction to opioids 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.
  • Medical condition that might affect metabolism or opioid analgesics or acetaminophen such as hepatitis, renal insufficiency or failure, hypo- or hyper-thyroidism, Addison's or Cushing's disease
  • Pregnant or breastfeeding
  • Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
  • SBP <100 mmHg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
  • 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 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: pain patches may influence both the amount of pain patients report as well as the level of relief they obtain from other treatments.
  • Taking any medication that might interact with one of the study medications, such as SSRI or tricyclic anti-depressants, antipsychotics, anti-malarial medications (quinidine or halofantrine), amiodarone or dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine or St. John's Wort.
  • Patients who have been previously enrolled in this same study: Patients may only be enrolled once.

Treatment and study plan

Acetaminophen

Drug

Acetaminophen 1g IV

Hydromorphone

Drug

Hydromorphone 1mg IV

Primary outcomes

  1. NRS Change at 60 minutes

    Time frame: 60 minutes

    Between group difference in change in NRS pain scores from baseline

Secondary outcomes

  1. Forego Additional Pain Medication

    Time frame: 60 minutes

    Difference in proportion of patients who choose to forego additional pain medication

  2. Receive Rescue Medication

    Time frame: Before 60 minutes

    Difference in proportion of patients who receive additional pain medication before primary outcome

  3. Experience Medication Side Effects

    Time frame: 120 Minutes

    Difference in proportion of patients who experience medication side effects grouped by GI (vomiting, nausea), dermatologic (pruritis, rash), and CNS (dizziness, drowsiness) categories.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Acetaminophen 1g IV vs Hydromorphone 1mg IV for the Treatment of Acute Pain in the Emergency Department

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 11, 2017
Registry last updated
Nov 17, 2017

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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