IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients
Condition: Acute Pain
MeSH terms: Emergencies; Acute Pain
Intervention: IV acetaminophen; IV placebo; hydromorphone
Intervention description: acetaminophen given intravenously; given intravenously; hydromorphone given intravenously
Intervention MeSH terms: Acetaminophen; Hydromorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Clinical Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The pharmacist working in an area inaccessible to ED staff will ensure blinding by creating identical vials containing either 1000 mg acetaminophen in 100 ml normal saline or 100 ml normal saline placebo and numbering them sequentially for use in this study.
Enrollment: 162.0
Sex: All
Minimum age: 21 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: pain; opioid analgesics; Emergency Department; randomized controlled trial; acetaminophen; hydromorphone

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).
    

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