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Sponsored by: |
Genesys |
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Information provided by: | Genesys |
ClinicalTrials.gov Identifier: | NCT00882960 |
Goal of the research will be to demonstrate a reduction in reported pain following the atomization and intra-nasal administration of Fentanyl versus the reduction in pain achieved from intravenous Fentanyl. It is hypothesized that pain should be reduced following fentanyl administration using the intra-nasal atomization equal to the intravenous delivery.
Condition | Intervention | Phase |
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Trauma Pain |
Drug: intravenous fentanyl Drug: intra-nasal fentanyl |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Atomization of Fentanyl: A Randomized Comparison Study of Intranasal Versus Intravenous Fentanyl for Pre-Hospital Pain Management |
Estimated Enrollment: | 500 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | April 2012 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
patients who are randomized to receive intravenous fentanyl for control of their pain
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Drug: intravenous fentanyl
An IV will be established and used to deliver Fentanyl at 50 micrograms to patients who meet pre-hospital protocol for pain management. Examples of this may be burn patients, fractures, trauma.
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2: Active Comparator
patients who are randomized to receive intra-nasal fentanyl for control of their pain
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Drug: intra-nasal fentanyl
a mucosal atomization device will be used to deliver 50 mcg of Fentanyl to patients who have been identified at requiring pre-hospital pain management
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Currently, pre-hospital providers have the ability to administer analgesia to patients through only intravenous routes. Often times patients have been exposed to the elements, present with poor anatomy, or are in such a position that makes establishing intravenous impractical or impossible. The lack of delivery method than prevents the patients from receiving humane and indicated pain medication. In patients who access is achieved, they are first subjected to a painful procedure that often will be repeated within twenty-four hours by most hospital policies and than subjects them to potential infection risk, being often times in less than aseptic conditions.
The goal of the study will be to test the method of administration of pain medication using atomization through an intra-nasal route as compared to the current standard of drug administration intravenous. The medication to be administered will be Fentanyl, a previously established and approved pre-hospital analgesic medication. As with any drug there are potential risks associated with unknown side effects or allergies, the risk would not be enhanced given the use of a different delivery device. Specific risks associated with the use of this delivery route would include but not be limited to potential soft tissue injuries, epistaxis, and aspiration
The study will measure reduction in pain following the delivery of atomized fentanyl via intra-nasal administration as compared with intravenous. We will ask participants to quantify their pain using the Wong-Baker FACES pain scale (previously established valid instrument of pain assessment) and assign a number to the pain they are feeling. The drug will than be administered using the atomizer and two subsequent reports of pain using the same scale will be taken along with vital signs.
Ages Eligible for Study: | 1 Year and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Michigan | |
Genesys Regional Medical Center | |
Grand Blanc, Michigan, United States, 48439 |
Study Chair: | Alan R Janssen, D.O. | Director of Emergency Medicine Residency, Genesys Regional Medical Center |
Principal Investigator: | Ryan P Kirby, M.D. | Resident physician, Genesys Regional Medical Center |
Study Director: | Stuart Etengoff, D.O. | Core Faculty, Department of Emergency Medicine, Genesys Regional Medical Center |
Responsible Party: | Genesys Regional Medical Center ( Dr. Ryan Kirby, M.D. ) |
Study ID Numbers: | 104904-1 |
Study First Received: | April 16, 2009 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00882960 History of Changes |
Health Authority: | United States: Institutional Review Board |
pre-hospital intra-nasal fentanyl patients requiring analgesia |
Anesthetics, Intravenous Fentanyl Anesthetics, General Adjuvants, Immunologic Wounds and Injuries Central Nervous System Depressants |
Anesthetics Narcotics Pain Peripheral Nervous System Agents Analgesics Analgesics, Opioid |
Anesthetics, Intravenous Fentanyl Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Narcotics Pharmacologic Actions Adjuvants, Anesthesia |
Sensory System Agents Anesthetics, General Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |