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

NCT ID: NCT02571634

Last Updated: 2016-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-01-31

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.

Conditions

Minor Procedural Pain

Keywords

intranasal fentanyl; conscious sedation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open label

Open label, no blinding, everyone receives Lazanda.

Group Type: OTHER

Lazanda

Intervention Type: DRUG

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

Interventions

Lazanda

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

Intervention Type: DRUG

Other Intervention Names

Intranasal Fentanyl

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Depomed

INDUSTRY

Sponsor Role: collaborator

Defense and Veterans Center for Integrative Pain Management

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael W. Bartoszek, MD

Role: PRINCIPAL_INVESTIGATOR

Womack Army Medical Center IPMC

Locations

Womack Army Medical Center

Fort Bragg, North Carolina, United States

Countries

United States

Other Identifiers

404457

Identifier Type: -

Identifier Source: org_study_id