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

• ClinicalTrials.gov Identifier: NCT02571634
• Recruitment Status: Completed
• First Posted: October 8, 2015
• Results First Posted: October 25, 2016
• Last Update Posted: October 25, 2016
• Sponsor: Defense and Veterans Center for Integrative Pain Management
• Collaborator: Depomed
• Information provided by (Responsible Party): Defense and Veterans Center for Integrative Pain Management

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Minor Procedural Pain	Drug: Lazanda	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: May 2015
• Actual Primary Completion Date: January 2016
• Actual Study Completion Date: January 2016

Arms and Interventions

Arm	Intervention/treatment
Open label; Open label, no blinding, everyone receives Lazanda.	Drug: Lazanda; Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.; Other Name: Intranasal Fentanyl

Outcome Measures

Primary Outcome Measures :

1. Safety and Tolerability as Measured by the Number of Adverse Events [ Time Frame: 24 hours ]
   Adverse events will be recorded by a yes or no as to their occurence

Secondary Outcome Measures :

1. Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool. [ Time Frame: Baseline, 15 min, 30 min, 45 min, and discharge ]
   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.
2. Patient Satisfaction Using a Likert Satisfaction Survey [ Time Frame: 24 hours ]
   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.
3. Adverse Events [ Time Frame: 24 hours ]
   Volunteers are monitored closely with vs, and sedation levels and any adverse issues will be recorded.
4. Sedation Level Assessed by POSS Tool [ Time Frame: Baseline, 15 min, 30 min, 45 min, discharge ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, North Carolina

Womack Army Medical Center

Fort Bragg, North Carolina, United States, 28310

Sponsors and Collaborators

Defense and Veterans Center for Integrative Pain Management

Depomed

Investigators

• Principal Investigator: Michael W. Bartoszek, MD; Womack Army Medical Center IPMC

More Information

• Responsible Party: Defense and Veterans Center for Integrative Pain Management
• ClinicalTrials.gov Identifier: NCT02571634
• Other Study ID Numbers: 404457
• First Posted: October 8, 2015
• Results First Posted: October 25, 2016
• Last Update Posted: October 25, 2016
• Last Verified: July 2016

Keywords provided by Defense and Veterans Center for Integrative Pain Management:

intranasal fentanyl; conscious sedation

Additional relevant MeSH terms:

Pain, Procedural; Pain; Neurologic Manifestations; Fentanyl; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Anesthetics