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Sponsored by: |
Montefiore Medical Center |
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Information provided by: | Montefiore Medical Center |
ClinicalTrials.gov Identifier: | NCT00682435 |
We wish to examine the safety and speed of onset of giving a dose of 1mg hydromorphone followed by an additional 1mg. Eligible patients will be given 1 mg IV hydromorphone. At 15 minutes, these patients will be asked the question, "Do you need more pain medication?" Those that answer "yes" will receive an additional 1mg IV hydromorphone. Those that answer "no" will not receive additional pain medications at that time period (15 minutes). Thus, we wish to give up to 2 mg IV hydromorphone titrated to patients' pain, which we believe will result in less incidence of oxygen desaturation.
If our study shows that this regimen is safe, its efficacy can be assessed in future trials. Positive results of those trials may lead to the use of this regimen to improve pain management in the emergency department.
Condition | Intervention | Phase |
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Pain |
Drug: Hydromorphone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | Safety and Speed of Onsent of Intravenous Hydromorphone Using Incremental 1mg Doses up to 2mg in the Treatment of Adult ED Patients With Moderate to Severe Pain |
Estimated Enrollment: | 350 |
Study Start Date: | June 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 21 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
C02 measurement greater than 46: In accordance with a similar study (04-12-360), three 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 3 subsets are as follows:
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 |
Principal Investigator: | Andrew Chang, M.D. | Motefiore Medical Center |
Responsible Party: | Montefiore Medical Center ( Andrew Chang, MD ) |
Study ID Numbers: | MMC0702028 |
Study First Received: | May 19, 2008 |
Last Updated: | May 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00682435 |
Health Authority: | United States: Institutional Review Board |
Nonedlerly patients with acute moderate to severe pain |
Hydromorphone Methamphetamine Amphetamine Pain |
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 |