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An observational feasibility study to assess the safety and effectiveness of intranasal fentanyl for radiofrequency ablations of the lumbar facet joints

PURPOSE: The purpose of the present observational, feasibility study is to assess the preliminary safety and effectiveness of intranasal fentanyl for lumbar facet radiofrequency ablation procedures. PATIENTS AND METHODS: This cohort observational study included 23 adult patients. Systolic and diasto...

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Autores principales: Bartoszek, Michael W, McCoart, Amy, Hong, Kyung-soo Jason, Haley, Chelsey, Highland, Krista Beth, Plunkett, Anthony R
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5315349/
https://www.ncbi.nlm.nih.gov/pubmed/28243139
http://dx.doi.org/10.2147/JPR.S124180
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author Bartoszek, Michael W
McCoart, Amy
Hong, Kyung-soo Jason
Haley, Chelsey
Highland, Krista Beth
Plunkett, Anthony R
author_facet Bartoszek, Michael W
McCoart, Amy
Hong, Kyung-soo Jason
Haley, Chelsey
Highland, Krista Beth
Plunkett, Anthony R
author_sort Bartoszek, Michael W
collection PubMed
description PURPOSE: The purpose of the present observational, feasibility study is to assess the preliminary safety and effectiveness of intranasal fentanyl for lumbar facet radiofrequency ablation procedures. PATIENTS AND METHODS: This cohort observational study included 23 adult patients. Systolic and diastolic blood pressures, heart rate, oxygen saturation percent, Pasero Opioid-Induced Sedation Scale score, and the Defense and Veterans Pain Rating Scale pain score were assessed prior to the procedure and intranasal fentanyl (100 μg) administration and every 15 minutes after administration, up to 60 minutes post administration. Follow-up of patient satisfaction with pain control and treatment was assessed 24 hours after discharge. The primary outcome was safety as evidenced by adverse events. Secondary outcomes included the above-mentioned vital signs and pain ratings. RESULTS: No adverse events occurred in the present study and all participants maintained an acceptable level of awareness throughout the assessment period. One-way repeated measures analyses of covariance tests with Bonferroni-adjusted means indicated that oxygen saturation, blood pressure, and heart rate changed from baseline, whereas pain scores were lower at post-administration levels compared with baseline. Finally, the majority of participants reported being satisfied with pain control and treatment. CONCLUSION: Preliminary evidence indicates that intranasal fentanyl is safe and effective for lumbar facet radiofrequency ablation procedures. Future rigorous randomized control trials are needed to confirm the present results and to examine the effects of intranasal fentanyl on intraoperative and postoperative opioid use.
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spelling pubmed-53153492017-02-27 An observational feasibility study to assess the safety and effectiveness of intranasal fentanyl for radiofrequency ablations of the lumbar facet joints Bartoszek, Michael W McCoart, Amy Hong, Kyung-soo Jason Haley, Chelsey Highland, Krista Beth Plunkett, Anthony R J Pain Res Clinical Trial Report PURPOSE: The purpose of the present observational, feasibility study is to assess the preliminary safety and effectiveness of intranasal fentanyl for lumbar facet radiofrequency ablation procedures. PATIENTS AND METHODS: This cohort observational study included 23 adult patients. Systolic and diastolic blood pressures, heart rate, oxygen saturation percent, Pasero Opioid-Induced Sedation Scale score, and the Defense and Veterans Pain Rating Scale pain score were assessed prior to the procedure and intranasal fentanyl (100 μg) administration and every 15 minutes after administration, up to 60 minutes post administration. Follow-up of patient satisfaction with pain control and treatment was assessed 24 hours after discharge. The primary outcome was safety as evidenced by adverse events. Secondary outcomes included the above-mentioned vital signs and pain ratings. RESULTS: No adverse events occurred in the present study and all participants maintained an acceptable level of awareness throughout the assessment period. One-way repeated measures analyses of covariance tests with Bonferroni-adjusted means indicated that oxygen saturation, blood pressure, and heart rate changed from baseline, whereas pain scores were lower at post-administration levels compared with baseline. Finally, the majority of participants reported being satisfied with pain control and treatment. CONCLUSION: Preliminary evidence indicates that intranasal fentanyl is safe and effective for lumbar facet radiofrequency ablation procedures. Future rigorous randomized control trials are needed to confirm the present results and to examine the effects of intranasal fentanyl on intraoperative and postoperative opioid use. Dove Medical Press 2017-02-10 /pmc/articles/PMC5315349/ /pubmed/28243139 http://dx.doi.org/10.2147/JPR.S124180 Text en © 2017 Bartoszek et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
spellingShingle Clinical Trial Report
Bartoszek, Michael W
McCoart, Amy
Hong, Kyung-soo Jason
Haley, Chelsey
Highland, Krista Beth
Plunkett, Anthony R
An observational feasibility study to assess the safety and effectiveness of intranasal fentanyl for radiofrequency ablations of the lumbar facet joints
title An observational feasibility study to assess the safety and effectiveness of intranasal fentanyl for radiofrequency ablations of the lumbar facet joints
title_full An observational feasibility study to assess the safety and effectiveness of intranasal fentanyl for radiofrequency ablations of the lumbar facet joints
title_fullStr An observational feasibility study to assess the safety and effectiveness of intranasal fentanyl for radiofrequency ablations of the lumbar facet joints
title_full_unstemmed An observational feasibility study to assess the safety and effectiveness of intranasal fentanyl for radiofrequency ablations of the lumbar facet joints
title_short An observational feasibility study to assess the safety and effectiveness of intranasal fentanyl for radiofrequency ablations of the lumbar facet joints
title_sort observational feasibility study to assess the safety and effectiveness of intranasal fentanyl for radiofrequency ablations of the lumbar facet joints
topic Clinical Trial Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5315349/
https://www.ncbi.nlm.nih.gov/pubmed/28243139
http://dx.doi.org/10.2147/JPR.S124180
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