Phase 4 N=23 Treatment

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

Minor Procedural Pain

Bottom Line

View on ClinicalTrials.gov: NCT02571634 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2016

Primary outcome: Primary: Safety and Tolerability as Measured by the Number of Adverse Events — 0 adverse events

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Lazanda (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Defense and Veterans Center for Integrative Pain Management
Primary completion: Jan 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety and Tolerability as Measured by the Number of Adverse Events	—	—
SECONDARY Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool.	4.70; 3.61; 2.52; 2.52; 1.65	—
SECONDARY Patient Satisfaction Using a Likert Satisfaction Survey	1.57; 1.57	—
SECONDARY Adverse Events	—	—
SECONDARY Sedation Level Assessed by POSS Tool	1; 1.04; 1.04; 1.04; 1.0	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02571634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.