Pain Relief Clinical Trial
Official title:
Efficacy and Adverse Events of Morphine and Fentanyl in an Aeromedical Setting
NCT number | NCT00580489 |
Other study ID # | IRB06-00065 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2006 |
Est. completion date | December 2008 |
Verified date | July 2022 |
Source | MetroHealth Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is exempt from informed consent by the MetroHealth Medical Center institutional review board (IRB), because two standards of care are used and there is no increased clinical risk to the patient due to the study. The researchers randomize either fentanyl or morphine to be given to trauma patients and record how their pain scale is treated along with observing for adverse events. They are looking to see if the hypothesized benefits of fentanyl (which is much more expensive than morphine) actually exist.
Status | Completed |
Enrollment | 204 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 69 Years |
Eligibility | Inclusion Criteria: - Trauma patient - Able to speak/communicate a pain scale Exclusion Criteria: - Age <18 - Age >69 - Initially or any time hypotensive - Prisoner |
Country | Name | City | State |
---|---|---|---|
United States | MetroHealth Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
MetroHealth Medical Center |
United States,
Smith MD, Wang Y, Cudnik M, Smith DA, Pakiela J, Emerman CL. The effectiveness and adverse events of morphine versus fentanyl on a physician-staffed helicopter. J Emerg Med. 2012 Jul;43(1):69-75. doi: 10.1016/j.jemermed.2011.05.018. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Change in Numeric Pain Score (NPS) From First to Last Dose | Mean difference in the numeric pain score (NPS) from the first dose to the final dose of medication administered.
A significant mean pain score change is defined as greater than or equal to 2 Numeric Pain Score (NPS) 0-10, 0 Least pain, 10 most pain |
Medication was administered over a mean transport time of 37 minutes in the Morphine group and 43 minutes in the Fentanyl group. | |
Secondary | Recording of Instance of Narcotic Side Effects. | Instances of narcotic side effects (vital sign derangement, itching, nausea/vomiting) . | Groups were observed a mean of 37 minutes in the Morphine Group and a mean of 43 minutes in the Fentanyl group for side effects. |
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