Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: H2O; 1+1
Intervention description: 2 mg IV hydromorphone; 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
Intervention MeSH terms: Hydromorphone
Phase: Phase 3
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: No
Keywords: acute; pain; emergency department; hydromorphone

Summary:

      The purpose of this study is to compare two opioid protocols ("H2O" and "1+1") for the
      treatment of acute severe pain in the emergency department. The investigators primary
      hypothesis is that the "H2O" protocol will be more efficacious than the "1+1" protocol in
      Emergency Department patients aged 21-64 years. The primary outcome is the proportion of
      patients in each arm who choose to forgo additional pain medication at 60 minutes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age greater than 21 years and less than 65 years: This is a study of non-elderly adult
             patients. In addition, patients aged 21 years and younger are automatically triaged to
             the Children's Emergency Department (ED).

          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 intravenous (IV)
             opioids

        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. CO2 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