Phase 4
Completed N=23
Lazanda Fentanyl Nasal Spray Pre Radiofrequency Nerve Ablations(RFA) of Lumbar Facet Joints
Minor Procedural Pain
Source: ClinicalTrials.gov NCT02571634 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Safety and Tolerability as Measured by the Number of Adverse Events — 0 adverse events
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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
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. Informational only — not medical advice.