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

Completed · Phase 4

Conditions studied: Minor Procedural Pain

In brief

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.

Key facts

Study ID

NCT02571634

Run by

Defense and Veterans Center for Integrative Pain Management

People needed

23

Starts

2015-05-01

Expected to finish

2016-01-01

Last updated by the study team

2016-10-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Womack Army Medical Center — Fort Bragg, North Carolina, United States

Full record on ClinicalTrials.gov

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