Intranasal Fentanyl for Pain Management

NCT00882960 | Unknown Phase 4

• 1 other identifier: 104904-1
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trauma; Pain

Keywords

pre-hospital; intra-nasal fentanyl; patients requiring analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

patients who are randomized to receive intravenous fentanyl for control of their pain

Drug: intravenous fentanyl

2

ACTIVE COMPARATOR

patients who are randomized to receive intra-nasal fentanyl for control of their pain

Drug: intra-nasal fentanyl

Interventions

intravenous fentanyl DRUG

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.

1

intra-nasal fentanyl DRUG

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

2

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genesys: lead

Study Sites (1)

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alan R Janssen, D.O.

  Director of Emergency Medicine Residency, Genesys Regional Medical Center

  STUDY CHAIR

• Ryan P Kirby, M.D.

  Resident physician, Genesys Regional Medical Center

  PRINCIPAL INVESTIGATOR

• Stuart Etengoff, D.O.

  Core Faculty, Department of Emergency Medicine, Genesys Regional Medical Center

  STUDY DIRECTOR

Central Study Contacts

Ryan P Kirby, M.D.

CONTACT

810-606-5933; ryan.kirby@genesys.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: April 17, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 4, 2011

Record last verified: 2009-05

Locations

US (1)