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Intranasal Fentanyl for Pain Management

Information source: Genesys
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Trauma; Pain

Intervention: intravenous fentanyl (Drug); intra-nasal fentanyl (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Genesys

Official(s) and/or principal investigator(s):
Alan R Janssen, D.O., Study Chair, Affiliation: Director of Emergency Medicine Residency, Genesys Regional Medical Center
Ryan P Kirby, M.D., Principal Investigator, Affiliation: Resident physician, Genesys Regional Medical Center
Stuart Etengoff, D.O., Study Director, Affiliation: Core Faculty, Department of Emergency Medicine, Genesys Regional Medical Center

Overall contact:
Ryan P Kirby, M.D., Phone: 810-606-5933, Email: ryan.kirby@genesys.org

Summary

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.

Clinical Details

Official title: Atomization of Fentanyl: A Randomized Comparison Study of Intranasal Versus Intravenous Fentanyl for Pre-hospital Pain Management

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary measure will be the change recorded in patients subjective pain using a standardized scale

Secondary outcome: Change in patients vital signs: blood pressure, respiratory rate, heart rate, pulse oximetry will be monitored at 5 and 10 minutes following Atomized Fentanyl

Detailed description: 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.

Eligibility

Minimum age: 14 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Persons who meet the current State of Michigan County of Oakland and County of

Genesee pre-hospital pain requiring analgesia.

- Examples of these patients would be those with fractures, kidney stones, or traumatic

injuries, burns. Exclusion Criteria:

- Patients who have compromised nasal pharynx such as those who have obvious fractures

or epistaxis.

- Additionally patients who are in the supine position for cervical spine

immobilization will be excluded.

Locations and Contacts

Ryan P Kirby, M.D., Phone: 810-606-5933, Email: ryan.kirby@genesys.org

Genesys Regional Medical Center, Grand Blanc, Michigan 48439, United States; Recruiting
Ryan Kirby, M.D., Phone: 810-606-5933, Email: ryan.kirby@genesys.org
Ryan P Kirby, M.D., Principal Investigator
Stuart Etengoff, D.O., Sub-Investigator
Alan R Janssen, D.O., Sub-Investigator
Additional Information

Starting date: April 2009
Last updated: May 3, 2011

Page last updated: August 23, 2015

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