|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Chang, Andrew, M.D. |
|---|---|
| Information provided by: | Chang, Andrew, M.D. |
| ClinicalTrials.gov Identifier: | NCT00195910 |
Purpose
To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a standard weight-based dose of IV morphine in adults presenting to the ED with acute severe pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Morphine and Hydromorphone |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of Hydromorphone as an Analgesic Alternative to Morphine in Acute, Severe Pain: A Randomized Clinical Trial |
| Estimated Enrollment: | 198 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | January 2005 |
There is widespread agreement that pain is under-treated in the ED (18). The current recommended treatment of acute pain in the ED setting is administration of an initial bolus of morphine followed by titration until adequate analgesia is achieved (19,20). Several studies have shown that even 0.1 mg/kg IV morphine (7-10 mg administered to the average 70-100 kg patient) inadequately treats many patients’ acute pain (21,22). In spite of this, we have observed that many emergency physicians and nurses are hesitant to give 7-10 mg of morphine as an initial IV dose. In contrast, we observed that these same healthcare providers were not similarly reluctant to administer a roughly equianalgesic dose of hydromorphone (1-1.5 mg), perhaps because the more potent hydromorphone is given in much smaller milligram quantities than morphine, thus providing the illusion of substantially less opioid administered to the patient. Having repeatedly observed this phenomenon, we reasoned that if a smaller milligram dose of hydromorphone were shown to provide an efficacy, safety, and side-effect profile comparable or superior to a larger milligram dose of morphine, it would provide evidence supporting use of hydromorphone as an alternative first line opioid in the treatment of acute pain presenting to the ED. As a practical corollary to this, we reasoned further that the increased willingness of healthcare providers to use hydromorphone might contribute to reducing one component of the multifaceted problem of oligoanalgesia in the ED (18).
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467 | |
| Principal Investigator: | Andrew K Chang, MD | Montefiore Medical Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00195910 History of Changes |
| Other Study ID Numbers: | MMC-04-08-225 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 12, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Acute Pain Emergency Department |
Morphine Hydromorphone Dilaudid |
|
Hydromorphone Morphine Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics |