Trial Outcomes & Findings for Lazanda Fentanyl Nasal Spray Pre Radiofrequency Nerve Ablations(RFA) of Lumbar Facet Joints (NCT NCT02571634)

NCT ID: NCT02571634

Last Updated: 2016-10-25

Results Overview

Adverse events will be recorded by a yes or no as to their occurence

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 23 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2016-10-25

Participant Flow

23 subjects were enrolled between July 20, 2015 and Dec 22, 2015. They were recruited from Womack Army Medical Center's Interdisciplinary Pain Management Center. All were scheduled for a radiofrequency ablation of the lumbar facet joints. All were consented prior to any assessment or treatment.

Participant milestones

Measure	Open Label Open label, no blinding, everyone receives Lazanda. Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Open Label n=23 Participants Open label, no blinding, everyone receives Lazanda. Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Adverse events will be recorded by a yes or no as to their occurence

Outcome measures

Measure	Open Label n=23 Participants Open label, no blinding, everyone receives Lazanda. Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control. There were no adverse events.
Safety and Tolerability as Measured by the Number of Adverse Events	0 adverse events

SECONDARY outcome

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

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.

Outcome measures

Measure	Open Label n=23 Participants Open label, no blinding, everyone receives Lazanda. Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control. There were no adverse events.
Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool. Pre procedure average pain score	4.70 pain score Standard Error .31
Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool. 15 minute average pain score	3.61 pain score Standard Error 0.42
Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool. 30 minute average pain score	2.52 pain score Standard Error 0.50
Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool. 45 minute average pain score	2.52 pain score Standard Error 0.43
Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool. Discharge pain score	1.65 pain score Standard Error 0.35

SECONDARY outcome

Timeframe: 24 hours

Population: Subjects were asked about pain control satisfaction and overall satisfaction using a 5 point likert scale. 1 = very satisfied, 2= satisfied, 3= neither satisfied nor dis-satisfied, 4= not satisfied and 5 = very unsatisfied

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.

Outcome measures

Measure	Open Label n=23 Participants Open label, no blinding, everyone receives Lazanda. Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control. There were no adverse events.
Patient Satisfaction Using a Likert Satisfaction Survey Overall satisfaction	1.57 Units on scale Standard Deviation .15
Patient Satisfaction Using a Likert Satisfaction Survey Pain control satisfaction	1.57 Units on scale Standard Deviation .15

SECONDARY outcome

Timeframe: 24 hours

Population: All 23 subjects were monitored with blood pressure, heart rate, oxygen saturation and sedation scores to determine any adverse events.

Volunteers are monitored closely with vs, and sedation levels and any adverse issues will be recorded.

Outcome measures

Measure	Open Label n=23 Participants Open label, no blinding, everyone receives Lazanda. Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control. There were no adverse events.
Adverse Events	0 number of adverse events

SECONDARY outcome

Timeframe: Baseline, 15 min, 30 min, 45 min, discharge

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

Outcome measures

Measure	Open Label n=23 Participants Open label, no blinding, everyone receives Lazanda. Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control. There were no adverse events.
Sedation Level Assessed by POSS Tool Pre procedure Poss score	1 POSS sedation scores Standard Error 0
Sedation Level Assessed by POSS Tool Poss score15minutes	1.04 POSS sedation scores Standard Error .04
Sedation Level Assessed by POSS Tool POSS 30 minutes	1.04 POSS sedation scores Standard Error .04
Sedation Level Assessed by POSS Tool POSS post 45 minutes	1.04 POSS sedation scores Standard Error .04
Sedation Level Assessed by POSS Tool POSS discharge	1.0 POSS sedation scores Standard Error .00

Adverse Events

Open Label

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Bartoszek, MD

Womack Army Medical Center

Phone: 910-907-6000

Email: michael.w.bartoszek.mil@mail.mil

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place