Protocolized vs Discretionary Use of Opioids in Acute Pain

Completed · Phase 3

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT00825370

Run by

Montefiore Medical Center

People needed

350

Starts

2008-10-01

Expected to finish

2009-05-01

Last updated by the study team

2018-06-12

Who can join

Age: 21 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Montefiore Medical Center Emergency Department — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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