Protocolized vs Discretionary Use of Opioids in Acute Pain

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Hydromorphone; Drug: IV opioid

Study type: Interventional

Funder types: Other

Identifiers

NCT00825370

MMC 0808278

Details and patient eligibility

About

We are testing whether patients who received protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg Intravenous (IV) hydromorphone 15 minutes later if the patients wants more) will have better pain relief and no more adverse events than patients receiving discretionary care, in which the patients receives whatever IV opioid the treating physician wants to give, in whatever dose.

Enrollment: 350 patients

Sex: All

Ages: 21 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 21 to 64 years.
2. Pain with onset within 7 days.
3. Emergency Department attending physician's judgment that patient's pain warrants use of intravenous opioids.
4. Normal mental status.

Exclusion criteria

1. Prior use of methadone.

2. Use of other opioids, tramadol, or heroin in the past seven days.

3. Prior adverse reaction to morphine, hydromorphone, or other opioids.

4. Chronic pain syndrome.

5. Alcohol intoxication.

6. Systolic Blood Pressure < 90 mm Hg.

7. Use of monoamine oxidase (MAO) inhibitors in past 30 days.

8. Weight less than 100 pounds.

9. Baseline room air oxygen saturation less than 95%.

10. C02 measurement greater than 46: In accordance with a number of similar studies that we have performed, 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Protocolized

Experimental group

Description:

1 mg IV 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?"

Treatment:

Drug: Hydromorphone

Discretionary Care

Active Comparator group

Description:

Patients receive an IV opioid the type and dose of which is determined by the treating physician

Treatment:

Drug: IV opioid