Radiofrequency Volumetric Tissue Reduction of the Palate in Subjects With Sleep-Disordered Breathing: Pain

8 May

Radiofrequency Volumetric Tissue Reduction of the Palate in Subjects With Sleep-Disordered Breathing: PainA VAS scale of 0 (no pain) to 10 (excruciating or intense pain) was used to document the existence of pain. A score from 0 to 3 depicted mild pain that did not require prescription pain medication. A separate nonvisual analog questionnaire registered the associated specific use of analgesic medications.
Speech: A VAS scale of 0 (no speech problems) to 10 (extreme difficulty talking) was used.
Swallowing: A VAS scale of 0 (no swallowing problems) to 10 (unable to swallow without pain even with pain medications) was used. canadian drug mall

Snoring: A VAS scale (amount of snoring noise during sleep) was used that required the subject, along with his or her bed partner, to assess snoring levels. This scale was completed at each visit and reflected an average score on those days between visits or treatment. The pretreatment scale was compared with the final posttreatment scale. The scale was from 0 (no snoring noise) to 10 (extreme noise—bed partner leaves the room).
Medical RF Device
RFe was delivered at 465 kHz using an RF generator with custom-fabricated needle electrodes and delivery device. The energy parameters were initially hand controlled by the primary investigator. A computerized energy algorithm controlled these parameters once safe ranges and limits were established (Somnus Medical Technologies Inc; Mountain View, Calif). The essential RFe parameters of power (watts), temperature limits (Celsius), resistance (ohms), treatment time (seconds), and total energy delivery in joules (wattX seconds) were controlled by this algorithm. The necessary feedback for temperature adjustment was provided by multiple microthermocouples imbedded along the electrode. A protective thermal sheath was used on the proximal portion of the electrode to eliminate surface damage. The maximum temperature gradient was regulated to <90°C with a target temperature of 80°C.
RF Procedure
The primary investigator performed all treatments and follow-up. The same clinical research nurse assisted during this time and maintained all records. Continuous BP, heart rate, and Sa02 measurements were recorded before, during, and after each session. The soft palate was sprayed with 20% benzocaine as a topical anesthetic. The midportion of the palate from the uvular base to the posterior nasal spine (PNS) was selected for treatment.