Lazanda Fentanyl Nasal Spray Pre Radiofrequency Nerve Ablations(RFA) of Lumbar Facet Joints

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness, feasibility and safety of intranasal fentanyl (Lazanda) as an alternative to the current gold standard (diazepam) to produce anxiolysis and improve patient comfort during and after radiofrequency ablations of the lumbar facet joints. If this pilot study shows a positive effect and Lazanda is found to be feasible and safe for use during procedures, future larger scale studies can be done.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Defense and Veterans Center for Integrative Pain Management
• Collaborator: Depomed
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• Male and female patients ASA(American Society of Anesthesiologist physical classification system) I-III

• 18 years of age and older Referred for lumbar facet RFA (radio-frequency ablation) by Womack IPMC (Interdisciplinary Pain Management Center)

Exclusion Criteria:

• Known allergy to Fentanyl or naloxone

• Diagnoses of allergic rhinitis with active rhinorrhea

• Pregnant or Breastfeeding

• Asthma or COPD (chronic obstructive pulmonary disease) that requires frequent rescue medications.

• Hepatic insufficiency with abnormal liver enzymes

• Noted decreased mental function

• Heart rate under 50 or BP below 90 systolic and/or 60 diastolic

• Myasthenia gravis diagnoses

• Acute narrow angle glaucoma

• Allergy to meperidine

• On medications with a known dangerous drug interactions to Fentanyl