Acetaminophen IV vs Hydromorphone IV in the ED

NCT ID: NCT03107481

Last Updated: 2017-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-04
• Study Completion Date: 2017-11-14

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.

Detailed Description

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.

Conditions

Pain, Acute

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Acetaminophen

Group Type: ACTIVE_COMPARATOR

Acetaminophen

Intervention Type: DRUG

Acetaminophen 1g IV

Hydromorphone

Group Type: ACTIVE_COMPARATOR

Hydromorphone

Intervention Type: DRUG

Hydromorphone 1mg IV

Interventions

Acetaminophen

Acetaminophen 1g IV

Intervention Type: DRUG

Hydromorphone

Hydromorphone 1mg IV

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Douglas P. Barnaby, MD, MS

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30119941 (View on PubMed)

Other Identifiers

2016-7296

Identifier Type: -

Identifier Source: org_study_id