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Sponsored by: |
Montefiore Medical Center |
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Information provided by: | Montefiore Medical Center |
ClinicalTrials.gov Identifier: | NCT00825370 |
We are testing whether patients who received protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patients wnats 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.
Condition | Intervention | Phase |
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Pain |
Drug: Hydromorphone Drug: IV opioid |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Protocolized vs Discretionary Use of Opioids in Acute Pain |
Estimated Enrollment: | 350 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Protocolized: Experimental
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?"
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Drug: Hydromorphone
1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later
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Discretionary Care: Active Comparator
Patients receive an IV opioid the type and dose of which is determined by the treating physician
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Drug: IV opioid
Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.
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Ages Eligible for Study: | 21 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 reporting less than a 20 pack-year smoking history who are having an asthma exacerbation
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Contact: Andrew K Chang, MD | 718-920-6626 | achang3@yahoo.com |
Contact: David Esses, MD | 718-920-6626 |
United States, New York | |
Montefiore Medical Center Emergency Department | Recruiting |
Bronx, New York, United States, 10467 | |
Principal Investigator: Andrew K Chang, MD |
Principal Investigator: | Andrew K Chang, MD | Montefiore Medical Center |
Responsible Party: | Montefiore Medical Center ( Andrew Chang, MD ) |
Study ID Numbers: | MMC 0808278 |
Study First Received: | January 19, 2009 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00825370 History of Changes |
Health Authority: | United States: Institutional Review Board |
Hydromorphone acute pain Protocolized Efficacy Safety |
Hydromorphone Central Nervous System Depressants Narcotics Pain |
Peripheral Nervous System Agents Analgesics Analgesics, Opioid |
Hydromorphone Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |