Protocolized vs Nonprotocolized Treatment of Adult ED Patients With Acute Severe Pain
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Hydromorphone; Nonprotocolized
Intervention description: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes; An IV opioid the type and dose of which will be determined by the treating clinician
Intervention MeSH terms: Hydromorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 224.0
Sex: All
Minimum age: 21 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Acute Pain, Emergency Department, ED, Hydromorphone, Dilaudid Protocolized Nonprotocolized Usual Care

Summary:

      Patients treated with protocolized pain management (1 mg of IV hydromorphone followed by an
      additional 1 mg IV hydromorphone if the patient wants more) will have better pain relief and
      no more adverse events than patients receiving non-protocolized pain management.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 21 to 64 years: Patients under the age of 21 are automatically triaged to the
             Children's Hospital at Montefiore Emergency Department, and hence cannot be enrolled
             in this study. Age 64 was selected as an upper range for inclusion because substantial
             evidence supports age as being an important determinant of morphine requirement over
             longer periods of time.

          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. Emergency Department (ED) attending physician's judgment that patient's pain warrants
             use of intravenous opioids: The factors that influence the decision to use intravenous
             opioids are complex and extensive. 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) or treatment (e.g., post-hysterectomy) 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 assess the role of
             intravenous (IV) opioids with the widest generalizability in the ED setting, we
             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 either a comprehensive
             list of diagnoses and situations in which opioids are indicated must be specified, or
             clinical judgment needs to be used. We have opted for the latter alternative.

          4. Normal mental status: In order to provide measures of pain experienced the patient
             needs to have a normal mental status. Orientation to person, place and time will be
             used as an indicator of sufficiently normal mental status to participate in the study.

        Exclusion Criteria:

          1. Prior use of methadone: the effect of methadone use on the perception of acute pain is
             unknown and suspected to be altered.

          2. Use of other opioids, tramadol, or heroin in the past seven days: to avoid introducing
             bias related to opioid tolerance that may alter the response to intravenous opioids
             thereby masking the effects of the medications administered.

          3. Prior adverse reaction to morphine, hydromorphone, or other opioids: An exception will
             be if the patient has received opioid medications in the past without adverse event
             (i.e. a patient may state he is allergic to morphine but has received hydromorphone in
             the past without any adverse effects)

          4. Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months
             resulting in alteration in 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, migraine, and peripheral neuropathies.

          5. Alcohol intoxication: the presence of alcohol intoxication may alter the perception,
             report, and treatment of pain. Alcohol intoxication will be determined to exist as
             judged by the treating physician.

          6. Systolic Blood Pressure < 90 mm Hg: Opioids produce peripheral vasodilation that may
             result in orthostatic hypotension or syncope.

          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 depression of respiration or coma.

          8. Weight less than 100 pounds: we are concerned that hydromorphone in doses up to 2 mg
             may not be safe in patients weighing less than 100 lbs.

          9. Baseline room air oxygen saturation less than 95%: since IV opioids may cause
             respiratory depression and result in hypoxemia, we are excluding this subgroup of
             patients.

         10. C02 measurement greater than 46: In accordance with a similar study (04-12-360), four
             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 4 subsets are as follows:

               1. All patients who have a history of chronic obstructive pulmonary disease (COPD)

               2. All patients who have a history of sleep apnea

               3. All patients who report a history of asthma together with greater than a 20
                  pack-year smoking history

               4. All patients reporting less than a 20 pack-year smoking history who are having an
                  asthma exacerbation