Objective/Hypot/iesis: Current options for the tr atment of noring have limited acceptance becaus of intolerance, expen e, pain, or n eed for g n ral an sth e la. A clinical trial u ing a new application of a previously known t chnology-radiofrequ ncy n rgy-wa investigated to determine its effi acy in th tr atment of snoring. Effects of tr atm nt on sp ch, swallowing, pain, noring, and d gr of 1 pi.n s w er · va)uat d. These effect s w r valuat cl by post-tr atment que tionna.ires. Methocls: Pro p ctiv nonrandomized tudy. All includ d ubj ct nor d at a level cons idered bothe rm to th ir b ed partner. A total of 43 patients were . nrolJ d at th University of Maryland (UM) and the orgia Ear Institute (GEi). Polysomnography was p rform d b for tr atment to eliminate patients with ignifi ant sleep apnea w ho had respiratory disturbanc indices (RDls) greater than 15 or nadir deaturation less than 80%. The mean pretreatment RDI for all patie nts who e nte r d the protocol at UM wa 6.7 ± 4.7. Nin patient completed the study in this group in aJJ other a sp cts, but clid not return for the ir sch dul d post-treatment polysomnogram. At GEi, pr tr atment polysomnograms revealed a mean RDI of 8.9 ± 3.8. Eleven pati nt at GEi completed the study in all oth r asp ects but did not re turn for their ch · dul d post-treatme nt poly omnogram. Radiofrequ ncy en rgy was d live red to the soft palate either in the midli.n (19 patients) at a mean of 698 ± 52 J pe r tr atm nt at UM or in the midline and lateral soft palat (24 pa tients) at a m an of 1,254 ± 191 J p er tr a tm nt at GEi. At UM the m an age w as 44.3 ± 8.4 y are, with a range from 20 to 59 y ar . Eighty-four p re nt of the patients w r m n. The mean body Laryngoscope 110: July 2000 1092 mass index {BMI) was 28.5 ± 3.2. Twenty-four patients were enrolled at GEi. The mean age was 44.0 ± 10.9 years, with a range from 23 to 63 years. Seventy-four percent of patients were men. The mean BMI was 27.7 ± 3.8. Snoring, pain, swaJJowing, and speech were assessed after each treatment at post-treatment day 1, 2, or 3; week 1; week "4; and week 7. Daytime sleepiness was assessed by the Epworth Sleepiness Scores (ESS) obtained at the same intervals. Results: Snoring was improved in 77% of patients after three treatments or Jess. S venty-nine percent of patients treated with the midli.ne technique at UM and 96% of patients treated with the midli. ne and left and right lateral palate technique at GEi achieved an improvement in their snoring to a level that was no longer bothersome to their bed partner. No persistent n egative impact was noted concerning speech or swallowing. Improvements in d egree of sleepiness were observed by comparing pretreatment and post-treatment ESS. ESS was significantly r educed (P < .005) after treatment from 10.2 ± 6.1to6.1±4.7 at UM, and at the GEi, from 8.75 ± 4.4 to 5.3 ± 3.2. After a treatment, 27% of the patients at UM and 29o/o at GEi required analgesics. Conclusions: This clinical trial demonstrates the efficacy, safety, and lack of pain encountered ...
The multiple lesion protocol was the most successful; reducing snoring from 7.6 to 2.7, on a VAS with an average of 1232 J delivered over 1.6 treatments. Temperature-controlled radiofrequency was found to be a minimally invasive, well-tolerated procedure that was safe and efficacious in this study group.
Perioperative steroids effectively lower the risk of postoperative airway distress and postoperative fever in children undergoing the primary repair of their cleft palate. This finding favors a customary role for perioperative steroid therapy in pediatric primary palatoplasty.
Objective
To determine if perioperative steroid therapy benefits pediatric primary palatoplasty patients.
Design
A prospective, double-blind, randomized trial with a placebo control.
Setting
An academic medical center.
Patients
Forty-five children undergoing primary repair of their cleft palate between 1989 and 1996 who were under the age of 48 months and without developmental delay or any associated syndrome.
Interventions
Intravenous dexamethasone sodium phosphate (0.25 mg/kg) or a placebo (5% dextrose in water) immediately preoperatively and once every 8 hours for two doses postoperatively.
Main outcome measures
Postoperative airway distress, fever, oral fluid intake, discharge eligibility, and palatal fistula formation.
Results
Perioperative steroid therapy significantly reduced the incidence of postoperative airway distress (p = .05) and postoperative fever (p = .02); postoperative oral fluid intake, discharge eligibility, and palatal fistula formation were not significantly affected.
Conclusions
Perioperative steroids effectively lower the risk of postoperative airway distress and postoperative fever in children undergoing the primary repair of their cleft palate. This finding favors a customary role for perioperative steroid therapy in pediatric primary palatoplasty.
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