Minor Procedural PainPhase 4RFANCT02571634
Lazanda Fentanyl Nasal Spray Pre Radiofrequency Nerve Ablations(RFA) of Lumbar Facet Joints
A Phase 4 study testing Lazanda in people with Minor Procedural Pain, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Minor Procedural Pain
- What is being tested?
- Lazanda
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jan 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Womack Army Medical Center
Fort Bragg, North Carolina, 28310
About this study
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
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.
Read the 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
- Being tested
- Lazanda
- Keywords
- intranasal fentanyl, conscious sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LazandaDrug
Also called Intranasal Fentanyl
Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.
| Study group | Role | What they receive |
|---|---|---|
| Open label | Other | Open label, no blinding, everyone receives Lazanda. Receives: Drug: Lazanda |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (4)
Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool.
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.
Measured: Baseline, 15 min, 30 min, 45 min, and discharge
Patient Satisfaction Using a Likert Satisfaction Survey
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.
Measured: 24 hours
Adverse Events
Volunteers are monitored closely with vs, and sedation levels and any adverse issues will be recorded.
Measured: 24 hours
Sedation Level Assessed by POSS Tool
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
Measured: Baseline, 15 min, 30 min, 45 min, discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Minor Procedural PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Defense and Veterans Center for Integrative Pain Management
- Sponsor type
- University, hospital or other
- Collaborators
- Depomed
- Responsible party
- Sponsor
- Investigators
- Michael W. Bartoszek, MD, Principal investigator, Womack Army Medical Center IPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571634
- Sponsor's protocol ID
- 404457
- Acronym
- RFA
- Status last verified
- Jul 2016
- First submitted
- 2 Oct 2015
- Last updated
- 25 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02571634
- Acronym / sponsor ID
- RFA / 404457
- Conditions
- Minor Procedural Pain
- Keywords
- intranasal fentanyl, conscious sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Defense and Veterans Center for Integrative Pain ManagementUniversity, hospital or other
- Collaborators
- Depomed
- Study start
- May 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Posted 25 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label | Other | Drug: LazandaOpen label, no blinding, everyone receives Lazanda. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LazandaAlso: Intranasal FentanylGiven pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control. | Drug | Open label |
Primary outcome
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
4 secondary outcomes
Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool.
Time frame: Baseline, 15 min, 30 min, 45 min, and discharge
Patient Satisfaction Using a Likert Satisfaction Survey
Time frame: 24 hours
Adverse Events
Time frame: 24 hours
Sedation Level Assessed by POSS Tool
Time frame: Baseline, 15 min, 30 min, 45 min, discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Minor Procedural Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael W. Bartoszek, MD principal investigator
Womack Army Medical Center IPMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lazanda in people with Minor Procedural Pain, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability as Measured by the Number of Adverse Events (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.