IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients

NCT ID: NCT03553498

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-27
• Study Completion Date: 2019-05-15

Brief Summary

The goal of this randomized clinical trial is to compare the analgesic efficacy and side effect profile of IV acetaminophen as an analgesic adjunctive medication to IV hydromorphone for the treatment of acute pain experienced by patients in the Emergency Department (ED).

Detailed Description

Multimodal treatment of pain is a commonly used strategy to control pain by combining analgesics with different and complementary mechanisms of action. Oral acetaminophen combined with opioids is a mainstay of treatment of mild to moderate pain, while the use of IV opioids is the standard for treatment of severe pain in the Emergency Department. An IV formulation of acetaminophen is widely used in Europe and has recently been approved in the US. It has been studied for treatment of acute post-operative pain and renal colic.

This randomized trial was designed to assess the effectiveness of the combination of IV acetaminophen and IV hydromorphone as a strategy to provide more effective treatment of acute severe pain in the Emergency Department with the possibility of reducing opioid consumption. All patients received 1 mg of IV hydromorphone. They were then randomized to receive either 1 g of IV acetaminophen or 100 mL of normal saline placebo. Measures of pain, vital signs, and presence of side effects were obtained immediately before IV hydromorphone was administered. Following receipt of the acetaminophen or placebo these same variables were measured at 15 minute intervals for the next 120 minutes. Additional analgesics were administered if patients requested them. Subsequent care of the patients was at the discretion of the treating attending physician.

Conditions

Acute Pain

Study Design

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

Study Groups

IV hydromorphone and IV acetaminophen

1000 mg IV acetaminophen administered over 5-10 minutes

1 mg hydromorphone administered over 5-10 minutes

Group Type: EXPERIMENTAL

IV acetaminophen

Intervention Type: DRUG

acetaminophen given intravenously

hydromorphone

Intervention Type: DRUG

hydromorphone given intravenously

IV hydromorphone and placebo

100 ml IV normal saline administered over 5-10 minutes

1 mg hydromorphone administered over 5-10 minutes

Group Type: PLACEBO_COMPARATOR

IV placebo

Intervention Type: DRUG

given intravenously

hydromorphone

Intervention Type: DRUG

hydromorphone given intravenously

Interventions

IV acetaminophen

acetaminophen given intravenously

Intervention Type: DRUG

IV placebo

given intravenously

Intervention Type: DRUG

hydromorphone

hydromorphone given intravenously

Intervention Type: DRUG

Other Intervention Names

Ofirmev; normal saline; Dilaudid

Eligibility Criteria

Inclusion Criteria

• Pain with onset within 7 days of the ED visit
• 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.
• ED attending physician's judgement that patient is not a chronic user of opioids or acetaminophen
• 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; 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 or nurse
• Not at risk of suicide assessed by triage nurse
• Systolic blood pressure <100 mmHg
• Heart Rate < 60/min
• Oxygen saturation < 95% on room air:
• Use of monoamine oxidase (MAO) inhibitors in past 30 days
• Use of transdermal pain patches
• Taking any medication that might interact with one of the study medications, such as a selective serotonin reuptake inhibitor (SSRI) or tricyclic anti-depressants, antipsychotics, anti-malarial medications (quinidine or halofantrine), amiodarone or dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritonavir, terbinafine or St. John's Wort.
• Patients who have been previously enrolled in this same study

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Polly Bijur

Professor of Emergency Medicine, Epidemiology and Population Health, and of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Polly Bijur

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018-8886

Identifier Type: -

Identifier Source: org_study_id