Clinical trial NCT02571634: Lazanda Fentanyl Nasal Spray Pre Radiofrequency Nerve Ablations(RFA) of Lumbar Facet Joints
Official title: Open Label Feasibility Pilot Study to Assess the Efficacy and Safety of the Use of Lazanda for Anxiolysis During Radiofrequency Nerve Ablation of Lumbar Facet Joints
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Minor Procedural Pain
Keywords: intranasal fentanyl
conscious sedation
Lead sponsor: Defense and Veterans Center for Integrative Pain Management
Sponsor class: OTHER
Collaborators: name: Depomed
First posted: 2015-10-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: The morning of the procedure/procedures the medication will be obtained from the omnicel by one of the qualified pain clinic study staff for the volunteers that have consented for that day. . It will be signed out on the designated form created for tracking and accountability purposes Patient consent for study participation will be confirmed.

Once in the procedure room a DVPRS (Defense and Veterans Pain Rating Scale) baseline pain score and POSS (Pasero Opioid-induced Sedation Scale) score will be assessed by a member of the research team. Baseline non-invasive blood pressure, heart rate, and oxygen saturation will be documented and continuous monitoring of these vital signs will commence by a provider credentialed by WAMC (Womack Army Medical Center) to perform anxiolysis with documentation every 15 minutes until discharge. A qualified RN (Registered Nurse), or physician will administer 100 mcg of Lazanda ten-fifteen minutes prior to the procedure The administration will be witnessed and confirmed on Appendix D. The unused 7 mcg will be wasted in a charcoal filled bag provided by the manufacturer and that bag will be disposed of per hospital policy. The waste will also be witnessed and noted. The Pasero Opioid-Induced Sedation Scale and a DVPRS pain score will be assessed every 15 minutes through the conclusion of the procedure and every 15 minutes up until discharge or for 1 hour post procedure whichever comes first. If naloxone is required during the procedure this will be noted as well. Any adverse or serious adverse events will be reported per regulatory regulations.

Eligibility 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

Primary outcomes:
measure: Safety and Tolerability as Measured by the Number of Adverse Events
timeFrame: 24 hours
Secondary outcomes:
measure: Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool.
timeFrame: Baseline, 15 min, 30 min, 45 min, and discharge
measure: Patient Satisfaction Using a Likert Satisfaction Survey
timeFrame: 24 hours
measure: Adverse Events
timeFrame: 24 hours
measure: Sedation Level Assessed by POSS Tool
timeFrame: Baseline, 15 min, 30 min, 45 min, discharge
Other outcomes:
Locations:
city: Fort Bragg
country: United States
facility: Womack Army Medical Center
state: North Carolina
Study officials:
affiliation: Womack Army Medical Center IPMC
name: Michael W. Bartoszek, MD
role: PRINCIPAL_INVESTIGATOR
References: