An observational feasibility study to assess the safety and effectiveness of intranasal fentanyl for radiofrequency ablations of the lumbar facet joints
Authors Bartoszek MW, McCoart A, Hong KJ, Haley C, Highland KB, Plunkett AR
Received 8 October 2016
Accepted for publication 14 November 2016
Published 10 February 2017 Volume 2017:10 Pages 359—364
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Michael Schatman
Michael W Bartoszek,1 Amy McCoart,2 Kyung-soo Jason Hong,3 Chelsey Haley,2 Krista Beth Highland,4 Anthony R Plunkett1
1Department of Anesthesiology, Womack Army Medical Center, Fort Bragg, NC, 2Clinical Investigations, Defense and Veterans Center for Integrative Pain Management, Henry M. Jackson Foundation, Womack Army Medical Center, Fort Bragg, NC, 3Research Department, The Center for Clinical Research, Sceptor Pain Foundation, Winston Salem, NC, 4Defense and Veterans Center for Integrative Pain Management, Henry M. Jackson Foundation, Uniformed Services University, Bethesda, MD, USA
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.
Keywords: analgesia, spinal procedures, chronic pain, sedation
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