Minor Procedural Pain
Conditions
Keywords
intranasal fentanyl, conscious sedation
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.
Interventions
DRUGLazanda
Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.
Sponsors
Depomed
Defense and Veterans Center for Integrative Pain Management
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability as Measured by the Number of Adverse Events | 24 hours | Adverse events will be recorded by a yes or no as to their occurence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool. | 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. |
| Patient Satisfaction Using a Likert Satisfaction Survey | 24 hours | 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. |
| Adverse Events | 24 hours | Volunteers are monitored closely with vs, and sedation levels and any adverse issues will be recorded. |
| Sedation Level Assessed by POSS Tool | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Open Label |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
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
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Open Label | Safety and Tolerability as Measured by the Number of Adverse Events | 0 adverse events |
Secondary
Adverse Events
Volunteers are monitored closely with vs, and sedation levels and any adverse issues will be recorded.
Time frame: 24 hours
Population: All 23 subjects were monitored with blood pressure, heart rate, oxygen saturation and sedation scores to determine any adverse events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Open Label | Adverse Events | 0 number of adverse events |
Secondary
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.
Time frame: Baseline, 15 min, 30 min, 45 min, and discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label | Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool. | Pre procedure average pain score | 4.70 pain score | Standard Error 0.31 |
| Open Label | 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 |
| Open Label | Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool. | 30 minute average pain score | 2.52 pain score | Standard Error 0.5 |
| Open Label | Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool. | Discharge pain score | 1.65 pain score | Standard Error 0.35 |
| Open Label | 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 |
Secondary
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label | Patient Satisfaction Using a Likert Satisfaction Survey | Pain control satisfaction | 1.57 Units on scale | Standard Deviation 0.15 |
| Open Label | Patient Satisfaction Using a Likert Satisfaction Survey | Overall satisfaction | 1.57 Units on scale | Standard Deviation 0.15 |
Secondary
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
Time frame: Baseline, 15 min, 30 min, 45 min, discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label | Sedation Level Assessed by POSS Tool | Pre procedure Poss score | 1 POSS sedation scores | Standard Error 0 |
| Open Label | Sedation Level Assessed by POSS Tool | Poss score15minutes | 1.04 POSS sedation scores | Standard Error 0.04 |
| Open Label | Sedation Level Assessed by POSS Tool | POSS 30 minutes | 1.04 POSS sedation scores | Standard Error 0.04 |
| Open Label | Sedation Level Assessed by POSS Tool | POSS post 45 minutes | 1.04 POSS sedation scores | Standard Error 0.04 |
| Open Label | Sedation Level Assessed by POSS Tool | POSS discharge | 1.0 POSS sedation scores | Standard Error 0 |