Comparing Intravenous Hydromorphone to Usual Care
Condition: Pain
Intervention: Hydromorphone; Usual care
Intervention description: 2 mg IV hydromorphone over to 2-3 minutes; Attending administers IV opioid of his choosing
Intervention MeSH terms: Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 350.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Acute; Pain; Emergency Department; Hydromorphone; Protocol

Summary:

      In this randomized controlled trial, 2 mg intravenous (IV) hydromorphone will be more
      efficacious than usual care (usual care is analgesic management according to the judgment of
      the attending physician caring for that patient) in emergency department (ED) patients aged
      21-64 years. The primary efficacy outcomes are the proportion of patients in each arm who
      choose to forgo additional pain medication in 30 minutes of entry into the study and the
      change in numerical rating scale (NRS) pain scores from baseline to 30 minutes post baseline.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age greater than 21 years and less than 65 years: This is a study of non-elderly adult
             patients.

          2. Pain with onset within 7 days: Pain within seven days is the definition of acute pain
             that has been used in ED literature.

          3. ED attending physician's judgment that patient's pain warrants IV opioids: The factors
             that influence the decision to use parenteral opioids are complex. An approach that is
             commonly taken to address the issue of patient selection in drug trials is to use a
             specific condition (e.g., renal colic) that would generally be thought to be
             appropriately treated with an opioid analgesic, thereby eliminating individual
             judgment about eligibility for the study. However in order to maximize the external
             validity of the role of opioids in the ED setting, the investigators decided to enroll
             patients with a variety of diagnoses, all with a complaint of acute pain. Opioids are
             not an appropriate treatment for all patients who present with a complaint of pain
             (e.g., gastroenteritis, migraine). Therefore, unless there is a restriction to
             patients with a specific diagnosis, either an extensive list of diagnoses and
             situations in which opioids are indicated must be specified, or clinical judgment
             needs to be used. The investigators have opted for the latter, since it most closely
             approximates the circumstances of clinical practice.

        Exclusion Criteria:

          1. Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly
             bias related to recent opioid use, since this may affect baseline levels of pain and
             need for analgesics.

          2. Prior adverse reaction to opioids.

          3. 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.

          4. Alcohol intoxication: the presence of alcohol intoxication as judged by the treating
             physician may alter pain perception.

          5. Systolic Blood Pressure <90 mm Hg: Opioids can produce peripheral vasodilation that
             may result in orthostatic hypotension.

          6. Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or
             above on room air in order to be enrolled.

          7. Use of monoamine oxidase (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.

          8. C02 measurement greater than 46: In accordance with standard protocol, three subsets
             of patients will have their CO2 measured using a handheld capnometer prior to
             enrollment in the study. If the CO2 measurement is greater than 46 then the patient
             will be excluded from the study. The 3 subsets are as follows:

               -  All patients who have a history of chronic obstructive pulmonary disease (COPD)

               -  All patients who report a history of asthma together with greater than a 20
                  pack-year smoking history

               -  All patients reporting less than a 20 pack-year smoking history who are having an
                  asthma exacerbation