IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients

• Status: Completed
• Trial end date: 2019-05-15
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine; Albert Einstein College of Medicine, Inc.
• Treatments: Acetaminophen; Analgesics; Hydromorphone

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

• SBP <100 mmHg

• HR < 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