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

Defense and Veterans Center for Integrative Pain Management23 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Minor Procedural Pain

Interventions

LazandaDRUG

Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Womack Army Medical Center

Fort Bragg, North Carolina, United States

Outcomes

Primary Outcomes

Safety and Tolerability as Measured by the Number of Adverse Events

Adverse events will be recorded by a yes or no as to their occurence

Time frame: 24 hours

Secondary Outcomes

Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool.

DVPRS pain scores will be recorded baseline and at 15 minutes post dosing, 30 minutes, 45 minutes and discharge. The DVPRS is a pain scale utilizing color coding descriptive terms and faces to describe pain levels from 0 meaning no pain and 10 the most excruciating pain ever.

Time frame: Baseline, 15 min, 30 min, 45 min, and discharge

Patient Satisfaction Using a Likert Satisfaction Survey

At 24 hour after the procedure a call was made asking the volunteer to provide a number on a scale to describe their satisfaction with their pain control and their overall satisfaction. A 5 point likert scale was used 1 = very satisfied, 2 satisfied, 3 neither satisfied nor dis-satisfied, 4 not satisfied and 5 very unsatisfied.

Time frame: 24 hours

Adverse Events

Volunteers are monitored closely with vs, and sedation levels and any adverse issues will be recorded.

Time frame: 24 hours

Sedation Level Assessed by POSS Tool

At baseline, 15 minutes post medication receipt, 30 minutes , 45 minutes and at discharge a Pasero-Opioid Sedation Scale Score was obtained. This scale is to measure alertness and amount of sedation. POSS was the abbreviated term used for this scale. The guidelines for that scale include: S= sleeping easily aroused 1= alert and awake; 2= slightly drowsy easily aroused; 3= frequently drowsy, drifts off to sleep during conversation; 4= somnolent, minimal or no response

Time frame: Baseline, 15 min, 30 min, 45 min, discharge

Data from ClinicalTrials.gov

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