Status:
COMPLETED
Protocolized vs Discretionary Use of Opioids in Acute Pain
Lead Sponsor:
Montefiore Medical Center
Conditions:
Pain
Eligibility:
All Genders
21-64 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Age 21 to 64 years.
- Pain with onset within 7 days.
- Emergency Department attending physician's judgment that patient's pain warrants use of intravenous opioids.
- Normal mental status.
Exclusion
- Prior use of methadone.
- Use of other opioids, tramadol, or heroin in the past seven days.
- Prior adverse reaction to morphine, hydromorphone, or other opioids.
- Chronic pain syndrome.
- Alcohol intoxication.
- Systolic Blood Pressure \< 90 mm Hg.
- Use of monoamine oxidase (MAO) inhibitors in past 30 days.
- Weight less than 100 pounds.
- Baseline room air oxygen saturation less than 95%.
- 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:
- All patients who have a history of chronic obstructive pulmonary disease (COPD)
- All patients who have a history of sleep apnea
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00825370
Start Date
October 1 2008
End Date
May 1 2009
Last Update
June 12 2018
Active Locations (1)
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1
Montefiore Medical Center Emergency Department
The Bronx, New York, United States, 10467