Intranasal Fentanyl for Pain Management

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Trauma
• Intervention / Treatment: Drug: intravenous fentanyl; Drug: intra-nasal 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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ryan P Kirby, M.D.; Phone Number: 810-606-5933; Email: ryan.kirby@genesys.org

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary measure will be the change recorded in patients subjective pain using a standardized scale	Pain will be assessed at 5 and 10 minutes post administration of Fentanyl

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in patients vital signs: blood pressure, respiratory rate, heart rate, pulse oximetry will be monitored at 5 and 10 minutes following Atomized Fentanyl	5 and 10 minutes post medication delivery

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Anticipated): April 1, 2012
• Study Completion (Anticipated): April 1, 2012

Study Registration Dates

• First Submitted: April 16, 2009
• First Submitted That Met QC Criteria: April 16, 2009
• First Posted (Estimate): April 17, 2009

Study Record Updates

• Last Update Posted (Estimate): May 4, 2011
• Last Update Submitted That Met QC Criteria: May 3, 2011
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: pre-hospital; intra-nasal fentanyl; patients requiring analgesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: 104904-1