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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2022
Source MetroHealth Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Periodic reports are made to the IRB.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
either fentanyl or morphine
either morphine 4mg IV or fentanyl 50mcg IV

Locations

Country Name City State
United States MetroHealth Medical Center Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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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