Radiofrequency Volumetric Tissue Reduction of the Palate in Subjects With Sleep-Disordered Breathing: Adverse Events Reporting

20 May
2014

Radiofrequency Volumetric Tissue Reduction of the Palate in Subjects With Sleep-Disordered Breathing: Adverse Events ReportingTwo of 22 subjects (9%) of subjects used a narcotic oral analgesic (hydrocodone) at some time after the first treatment. All other subjects used nothing or opted for over-the-counter medications. The most commonly used analgesic was acetaminophen (500 mg), with a minor use of ibuprofen or aspirin. In Table 4, it is noted that the mean pain score was 1.48± 1.8, and yet, 47.5% of the patients in treatment session 1 used pain medications. This is due in part to the fact that when we first started RF treatment, hydrocodone was initially systematically prescribed as part of the protocol since it was unknown what the discomfort levels would be. Some of the patients used this medication or other over-the-counter drugs in anticipation of pain. Although these subjects’ scores were low on the pain scale, this medication use was, by protocol, included in the overall percent using pain medication.
Snoring: Snoring scores by VAS scale pretreatment were a mean of 8.3±1.8, and at posttreatment they were a mean of 1.9±1.2, showing a change of — 6.4±1.7 (p<0.0001). canadian family pharmacy

Adverse Events Reporting
There were no major complications during this investigation, including bleeding, infection, tissue slough, speech problems, or swallowing problems. No airway compromise was seen in any subject, even though there was some initial edematous changes at 1 to 3 days after treatment. The polysomnographic parameters that were examined to evaluate the effects of an edematous response were the RDI, nadir Sa02 and nadir Pes (Table 2). The RDI, nadir Sa02, and nadir Pes changed over baseline in 48 to 72 h. Statistically significant changes were only for the RDI and nadir Sa02. Generally the edematous response, as seen at 24 h and 48 to 72 h, was not sufficient to clinically obstruct the airway awake or during sleep.
Eleven patients, during the course of one of their treatments, experienced some erosion of the surface mucosa 2 to 4 days after treatment, but these were classified as minor events. Oral analgesics were used by only 6 of these 11 subjects. The use was limited to acetaminophen for 1 to 6 days in low doses, except for 1 patient who used hydrocodone tablets over the early course of healing. Each lesion healed spontaneously without treatment. These 11 events out of 117 treatments represented a 7.6% incidence.

top