NCT00882960

Intranasal Fentanyl for Pain Management

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Genesys · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Trauma
• Pain

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2009-04-17
• Last updated: 2011-05-04

Locations

1 site across 1 country: United States