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

Defense and Veterans Center for Integrative Pain Management

Status and phase

Completed

Phase 4

Conditions

Minor Procedural Pain

Treatments

Drug: Lazanda

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02571634

404457

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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