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

NCT02571634 | Completed Phase 4 Results

• 1 other identifier: 404457
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Minor Procedural Pain

Keywords

intranasal fentanyl; conscious sedation

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Secondary Outcomes (4)

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

  Baseline, 15 min, 30 min, 45 min, and discharge

• Patient Satisfaction Using a Likert Satisfaction Survey

  24 hours

• Adverse Events

  24 hours

• Sedation Level Assessed by POSS Tool

  Baseline, 15 min, 30 min, 45 min, discharge

Study Arms (1)

Open label

OTHER

Open label, no blinding, everyone receives Lazanda.

Drug: Lazanda

Interventions

Lazanda DRUG

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

Also known as: Intranasal Fentanyl

Open label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients ASA(American Society of Anesthesiologist physical classification system) I-III
• 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

Sponsors & Collaborators

• Defense and Veterans Center for Integrative Pain Management: lead
• Depomed: collaborator

Study Sites (1)

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

Location

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

This was a pilot study with a small number enrolled without comparison to any other groups. Future studies indicated with larger numbers and comparison to other forms of sedation.

Results Point of Contact

• Title: Michael Bartoszek, MD
• Organization: Womack Army Medical Center

michael.w.bartoszek.mil@mail.mil

910-907-6000

Study Officials

• Michael W. Bartoszek, MD

  Womack Army Medical Center IPMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 8, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 25, 2016
• Results First Posted: October 25, 2016

Record last verified: 2016-07

Locations

US (1)