Intranasal Fentanyl for Pain Management

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Genesys.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Genesys
ClinicalTrials.gov Identifier:
NCT00882960
First received: April 16, 2009
Last updated: May 3, 2011
Last verified: May 2009
  Purpose

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
Trauma
Pain
Drug: intravenous fentanyl
Drug: intra-nasal fentanyl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Atomization of Fentanyl: A Randomized Comparison Study of Intranasal Versus Intravenous Fentanyl for Pre-hospital Pain Management

Resource links provided by NLM:


Further study details as provided by Genesys:

Primary Outcome Measures:
  • The primary measure will be the change recorded in patients subjective pain using a standardized scale [ Time Frame: Pain will be assessed at 5 and 10 minutes post administration of Fentanyl ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in patients vital signs: blood pressure, respiratory rate, heart rate, pulse oximetry will be monitored at 5 and 10 minutes following Atomized Fentanyl [ Time Frame: 5 and 10 minutes post medication delivery ] [ Designated as safety issue: Yes ]

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
Active Comparator: 1
patients who are randomized to receive intravenous fentanyl for control of their pain
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.
Active Comparator: 2
patients who are randomized to receive intra-nasal fentanyl for control of their pain
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

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

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882960

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

Locations
United States, Michigan
Genesys Regional Medical Center Recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Ryan Kirby, M.D.    810-606-5933    ryan.kirby@genesys.org   
Principal Investigator: Ryan P Kirby, M.D.         
Sub-Investigator: Stuart Etengoff, D.O.         
Sub-Investigator: Alan R Janssen, D.O.         
Sponsors and Collaborators
Genesys
Investigators
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
  More Information

No publications provided

Responsible Party: Dr. Ryan Kirby, M.D., Genesys Regional Medical Center
ClinicalTrials.gov Identifier: NCT00882960     History of Changes
Other Study ID Numbers: 104904-1
Study First Received: April 16, 2009
Last Updated: May 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Genesys:
pre-hospital
intra-nasal fentanyl
patients requiring analgesia

Additional relevant MeSH terms:
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 18, 2014