Acetaminophen IV vs Hydromorphone IV in the ED

NCT03107481 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 2016-7296
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Acute

Keywords

Acetaminophen; Hydromorphone; Emergency Department; Narcotics; Analgesics, Opioid; Analgesics, Non-Narcotic

Outcome Measures

Primary Outcomes (1)

• NRS Change at 60 minutes

  Between group difference in change in NRS pain scores from baseline

  60 minutes

Secondary Outcomes (3)

• Forego Additional Pain Medication

  60 minutes

• Receive Rescue Medication

  Before 60 minutes

• Experience Medication Side Effects

  120 Minutes

Study Arms (2)

Acetaminophen

ACTIVE COMPARATOR

Drug: Acetaminophen

Hydromorphone

ACTIVE COMPARATOR

Drug: Hydromorphone

Interventions

Acetaminophen DRUG

Acetaminophen 1g IV

Acetaminophen

Hydromorphone DRUG

Hydromorphone 1mg IV

Hydromorphone

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• Barnaby DP, Chertoff AE, Restivo AJ, Campbell CM, Pearlman S, White D, Bijur PE, Gallagher EJ. Randomized Controlled Trial of Intravenous Acetaminophen Versus Intravenous Hydromorphone for the Treatment of Acute Pain in the Emergency Department. Ann Emerg Med. 2019 Feb;73(2):133-140. doi: 10.1016/j.annemergmed.2018.06.019. Epub 2018 Aug 14.

  PMID: 30119941 DERIVED

MeSH Terms

Conditions

Acute Pain; Emergencies

Interventions

Acetaminophen; Hydromorphone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 11, 2017
• Study Start: June 4, 2017
• Primary Completion: November 14, 2017
• Study Completion: November 14, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)