Acetaminophen IV vs Hydromorphone IV in the ED

• Status: Completed
• Trial end date: 2017-11-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Montefiore Medical Center
• Treatments: Acetaminophen; Analgesics; Hydromorphone

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.