Protocolized vs Discretionary Use of Opioids in Acute Pain

NCT ID: NCT00825370

Last Updated: 2018-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-05-31

Brief Summary

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Protocolized

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?"

Group Type: EXPERIMENTAL

Hydromorphone

Intervention Type: DRUG

1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later

Discretionary Care

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

Group Type: ACTIVE_COMPARATOR

IV opioid

Intervention Type: DRUG

Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.

Interventions

Hydromorphone

1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later

Intervention Type: DRUG

IV opioid

Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.

Intervention Type: DRUG

Other Intervention Names

Dilaudid; Discretionary care

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Andrew Chang, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew K Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center Emergency Department

The Bronx, New York, United States

Countries

United States

Other Identifiers

MMC 0808278

Identifier Type: -

Identifier Source: org_study_id