Adenoidectomy and adenotonsillectomy for recurrent acute otitis media: parallel randomized clinical trials in children not previously treated with tympanostomy tubes. Intranasal budesonide treatment for children with mild obstructive sleep apnea syndrome. Temperature-controlled radiofrequency treatment of tonsillar hypertrophy for reduction of upper airway obstruction in pediatric patients. Randomised study of three non-surgical treatments in mild to moderate obstructive sleep apnoea. Tonsillectomy and adenotonsillectomy for recurrent throat infection in moderately affected children. Nasal-CPAP, surgery, and conservative management for treatment of obstructive sleep apnea syndrome. A randomized study. Frequency of surgery among children who have adenotonsillar hypertrophy and improve after treatment with nasal beclomethasone. The effect of intravenous dexamethasone in pediatric adenotonsillectomy. Mandibular advancement appliances and obstructive sleep apnoea: a randomized clinical trial.
Adenoidectomy and adenotonsillectomy are commonly performed in US children to reduce the occurrence of persistent or recurrent otitis media, but evidence supporting the efficacy of the operations is limited.
                To test the efficacy of adenoidectomy and adenotonsillectomy in children with persistent or recurrent otitis media who had not previously undergone tube placement and to compare the relative efficacy of adenoidectomy alone vs adenotonsillectomy in such children.
                Two parallel randomized clinical trials.
                A total of 461 children aged 3 to 15 years were enrolled at Children's Hospital of Pittsburgh, Pa, between April 1980 and April 1994. Four hundred ten children were observed for up to 3 years.
                Children without recurrent throat infection or tonsillar hypertrophy (304 enrolled; 266 followed up) were randomized to either an adenoidectomy, adenotonsillectomy, or control group; children who had such conditions (157 enrolled; 144 followed up) were randomized to an adenotonsillectomy or control group.
                Occurrence rate of episodes of acute otitis media by treatment group and estimated proportion of time with otitis media.
                In both trials, most subjects were eligible because of recurrent acute otitis media, with or without persistent otitis media with effusion. A total of 47 children assigned to surgical treatment groups had no surgery. The efficacy of surgery in both trials was modest and limited mainly to the first follow-up year. The largest differences in that year were found in the 3-way trial between the adenotonsillectomy group and the control group: mean annual rate of episodes of acute otitis media, 1.4 vs 2.1 (P<.001); and mean estimated percentage of time with otitis media, 18.6% vs 29.9% (difference, 11.3%; 95% confidence interval, 4.4%-18.2%; P=.002). Perioperative and postoperative complications or other adverse events occurred not infrequently, especially among subjects undergoing adenotonsillectomy (14.6%).
                Our study showed limited and short-term efficacy of both adenoidectomy and adenotonsillectomy; given the risks, morbidity, and costs of these procedures, these data suggest that neither operation should ordinarily be considered as a first surgical intervention in children whose only indication is recurrent acute otitis media. Intranasal corticosteroids have been advanced as a nonsurgical therapeutic alternative for pediatric obstructive sleep apnea syndrome, particularly for patients with mild disease, and aims at reducing the size of hypertrophic adenotonsillar tissue.
                Of 71 possible candidates, 62 children with polysomnographically diagnosed mild obstructive sleep apnea syndrome were recruited onto a double-blind, randomized, crossover trial of intranasal budesonide (32 microg per nostril at bedtime) or placebo for 6 weeks followed by an additional 6-week treatment in the alternative treatment arm after allowing for a 2-week washout period. Polysomnographic assessment and radiographs for assessment of adenoid size were performed after completion of each phase.
                There were significant improvements in both polysomnographic measures (sleep latency, slow-wave sleep, and rapid-eye-movement sleep), in the magnitude of respiratory disturbance (apnea/hypopnea index, nadir pulse oxygen saturation), and in adenoid size among the 48 children who completed the treatment phase compared with 32 children who received placebo in their initial arm, with normalization of sleep measures in 54.1% of the treated children. Furthermore, discontinuation of treatment for 8 weeks for 25 children revealed a sustained duration of the initial treatment effect.
                A 6-week treatment with intranasal budesonide effectively reduced the severity of mild obstructive sleep apnea syndrome and the magnitude of the underlying adenoidal hypertrophy, and this effect persisted for at least 8 weeks after cessation of therapy. These findings justify the use of topical steroids as the initial therapeutic option in otherwise healthy children with mild obstructive sleep apnea. To determine if temperature-controlled radiofrequency (TCRF) tonsil reduction and adenoidectomy (TCRF&A) and conventional tonsillectomy and adenoidectomy (T&A) are statistically similar in outcome and to compare morbidity between TCRF&A and conventional T&A.
                Randomized control trial.
                Tertiary care children's hospital.
                The study population comprised 23 patients aged 2.6 to 12.5 years with symptoms of obstructive sleep apnea, hypertrophic tonsils with no other areas of upper airway obstruction with the exception of hypertrophic adenoids, and a body mass index (calculated as weight in kilograms divided by the square of height in meters) of less than 30.
                Temperature-controlled radiofrequency tonsil reduction (mean +/- SD, 12.6 +/- 1.5 ablations per patient and 994.68 +/- 91.88 J per insertion) and adenoidectomy or traditional bovie T&A.
                Primary outcomes were respiratory distress index and total volume reduction. Secondary outcomes include postoperative pain, daytime sleepiness, speech and swallowing problems, weight and diet, narcotic use, and analogue snoring scale.
                The respiratory distress index difference for TCRF&A was 5.63 vs 6.56 for standard T&A. On postoperative day 1 for the 13 patients who underwent TCRF&A, 0 reported severe pain, 11 (85%) had mild to moderate pain, and 2 (15%) had no pain. In the 10 patients who underwent standard T&A, 1 (10%) had severe pain and 9 (90%) had mild to moderate pain. By postoperative week 1, all TCRF&A patients experienced mild or no pain, whereas 1 (10%) of the standard T&A patients still had moderate pain. Mean visual analogue snore scores (0-10) 4 weeks after surgery were less than 1 for both groups. The mean +/- SD weight loss at postoperative week 1 for TCRF tonsil reduction patients was 1.0 +/- 3.5 lb (0.45 +/- 1.58 kg) vs 4.6 +/- 3.9 lb (2.07 +/- 1.76 kg) for standard T&A patients. Return to normal diet at postoperative week 1 occurred in 11 TCRF&A patients (85%) and 0 standard T&A patients.
                The respiratory distress indexes were similar for TCRF&A patients and standard T&A patients. In addition, there were similar analog snoring scales, decreased pain, and weight loss. Patients with mild to moderate obstructive sleep apnoea (OSA) may be managed with different treatment options. This study compared the effectiveness of three commonly used non-surgical treatment modalities.
                Subjects with mild to moderate OSA were randomised to one of three treatment groups for 10 weeks: conservative measures (sleep hygiene) only, continuous positive airways pressure (CPAP) in addition to conservative measures or an oral appliance in addition to conservative measures. All overweight subjects were referred to a weight-reduction class. OSA was assessed by polysomnography. Blood pressure was recorded in the morning and evening in the sleep laboratory. Daytime sleepiness was assessed with the Epworth Sleepiness Scale. Health-related quality of life (HRQOL) was assessed with the 36-Item Short-Form Health Survey (SF-36) and Sleep Apnoea Quality of Life Index (SAQLI).
                101 subjects with a mean (SEM) apnoea-hypopnoea index (AHI) of 21.4 (1.1) were randomised to one of the three groups. The severity of sleep-disordered breathing was decreased in the CPAP and oral appliance groups compared with the conservative measures group, and the CPAP group was significantly better than the oral appliance group. Relief from sleepiness was significantly better in the CPAP group. CPAP was also better than the oral appliance or conservative measures in improving the "bodily pain" domain, and better than conservative measures in improving the "physical function" domain of SF-36. Both CPAP and the oral appliance were more effective than conservative measures in improving the SAQLI, although no difference was detected between the CPAP and oral appliance groups. CPAP and the oral appliance significantly lowered the morning diastolic blood pressure compared with baseline values, but there was no difference in the changes in blood pressure between the groups. There was also a linear relationship between the changes in AHI and body weight.
                CPAP produced the best improvement in terms of physiological, symptomatic and HRQOL measures, while the oral appliance was slightly less effective. Weight loss, if achieved, resulted in an improvement in sleep parameters, but weight control alone was not uniformly effective. In previous clinical trials involving children severely affected with recurrent throat infection (7 or more well-documented, clinically important, adequately treated episodes of throat infection in the preceding year, or 5 or more such episodes in each of the 2 preceding years, or 3 or more such episodes in each of the 3 preceding years), we found tonsillectomy efficacious in reducing the number and severity of subsequent episodes of throat infection for at least 2 years. The results seemed to warrant the election of tonsillectomy in children meeting the trials' stringent eligibility criteria but also provided support for nonsurgical management. We undertook the present trials to determine 1) whether tonsillectomy would afford equivalent benefit in children who were less severely affected than those in our earlier trials but who nonetheless had indications for tonsillectomy comparable to those in general use, and 2) whether, in such children, the addition of adenoidectomy would confer additional benefit.
                We conducted 2 parallel randomized, controlled trials in the Ambulatory Care Center of Children's Hospital of Pittsburgh. To be eligible, children were required to have had a history of recurrent episodes of throat infection that met standards slightly less stringent than the standards used in our earlier trials regarding either the frequency of previous episodes or their clinical features or their degree of documentation, but not regarding >1 of those parameters. These reduced standards were nonetheless more stringent than those in current official guidelines, which list "3 or more infections of tonsils and/or adenoids per year despite adequate medical therapy" as an indication for tonsillectomy or adenotonsillectomy. Of 2174 children referred by physicians or parents, 373 met the current trials' eligibility criteria and 328 were enrolled. Of these, 177 children without obstructing adenoids or recurrent or persistent otitis media were randomized to either a tonsillectomy group, an adenotonsillectomy group, or a control group (the 3-way trial), and 151 children who had 1 or more such conditions were randomized to either an adenotonsillectomy group or a control group (the 2-way trial). Outcome measures were the occurrence of episodes of throat infection during the 3 years of follow-up; other, indirect measures of morbidity; and complications of surgery.
                By various measures, the incidence of throat infection was significantly lower in surgical groups than in corresponding control groups during each of the 3 follow-up years. However, even among control children, mean rates of moderate or severe episodes were low, ranging from 0.16 to 0.43 per year. Adenotonsillectomy was no more efficacious than tonsillectomy alone. Of 203 children treated with surgery, 16 (7.9%) had surgery-related complications of varying types and severity.
                The modest benefit conferred by tonsillectomy or adenotonsillectomy in children moderately affected with recurrent throat infection seems not to justify the inherent risks, morbidity, and cost of the operations. We conclude that, under ordinary circumstances, neither eligibility criteria such as those used for the present trials nor the criterion for surgery in current official guidelines are sufficiently stringent for use in clinical practice. To assess separately the effectiveness and safety of nasal-continuous positive airway pressure (N-CPAP) and that of surgery in comparison to conservative management in patients with obstructive sleep apnea syndrome (OSAS). DESIGN. A randomized study with 1-year follow-up.
                A university hospital acting as a referral center for OSAS.
                Symptomatic patients with OSAS (72 male and 4 female patients aged 18 to 65 years), who had oxygen desaturations in the overnight recording.
                After the initial diagnostic workup, patients were considered to be candidates for either N-CPAP (44 patients) or surgical treatment (uvulopalatopharyngoplasty [UPPP] with or without mandibular osteotomy) (32 patients). Within the groups, the patients were then randomized to either the assigned treatment or conservative management.
                The number of nocturnal oxygen desaturation events of 4% or more per hour in bed (ODI4); daytime somnolence; side effects.
                N-CPAP Group: Compliance with N-CPAP therapy at 1 year was 13 of 21. The most common reason for noncompliance was general intolerance of CPAP. All compliant patients had a normal ODI4 ( < 10), whereas 1 of 20 of their control subjects had a normal finding. Patients receiving active treatment were significantly less somnolent than their control subjects at 1 year (p < 0.05). SURGERY GROUP: At 1 year, 7 of 18 of the surgically treated and 1 of 14 of the conservatively treated patients had a normal ODI4 (p < 0.001). Daytime somnolence was significantly less severe in the surgically treated patients compared with their control subjects (p < 0.001) both at 3 and 12 months. The overall postoperative complication rate was 22%.
                N-CPAP is an effective therapy for OSAS, but compliance is a problem. Surgical therapy (UPPP with or without mandibular osteotomy) needs further evaluation. To describe the long-term outcome of a cohort of children with symptomatic adenotonsillar hypertrophy treated with aqueous nasal beclomethasone.
                The children enrolled completed a 4-week single-blind, saline solution controlled crossover study of aqueous beclomethasone (total: 400 micro g/d). In a 24-week open-label follow-on study, beclomethasone 200 micro g/d was offered to all patients. During a 100-week follow-up, the degree of nasal obstruction and the frequency of adenotonsillectomy were assessed.
                Fifty-three children of the 60 enrolled completed the study. After the 4-week crossover trial, the severity of nasal obstruction of 24 children (45%) significantly decreased during the use of nasal steroids, but no child improved when saline solution was used. At 24, 52, and 100 weeks, the 24 children who had initially improved showed a significant decrease of the severity of nasal obstruction and of the frequency of adenotonsillectomy (54% vs 83%) compared with the 29 children who had not responded after the initial steroidal therapy.
                Evidence from this study suggests that 45% of children with adenoidal hypertrophy improved after 2 weeks of steroidal therapy. Among these children, an additional 24-week treatment at a lower steroid dosage was associated with a significant 52- and 100-week clinical improvement and with reduction of adenotonsillectomy compared with children (55%) who had not responded after the initial 2-week steroidal therapy. To determine whether the intravenous administration of dexamethasone sodium phosphate before tonsillectomy and adenoidectomy can reduce the morbidity from, and increase the safety of, this procedure.
                Prospective, randomized, double-blind, placebo-controlled clinical trial.
                A university medical center, caring for both ambulatory and hospitalized children.
                Eighty children aged 3 to 15 years undergoing tonsillectomy and adenoidectomy for either chronic tonsillitis or adenotonsillar hypertrophy (obstructive sleep apnea and/or upper airway obstruction).
                Forty-one children received intravenous dexamethasone sodium phosphate (1 mg/kg up to 16 mg) and 39 received placebo before undergoing an electrocautery dissection tonsillectomy and adenoidectomy.
                Postoperative oral intake, pain, vomiting, temperature, and complications.
                Patients who received intravenous dexamethasone had significantly less trismus, vomiting, and elevations of temperature 6 hours after surgery and more oral intake (liquids and soft solids) at 24 hours. Three children, all of whom were in the placebo group, had emergency department visits for pain and dehydration. Each group had one child who had a secondary hemorrhage (no surgery needed), one child who had pneumonia, and one child who had night terrors.
                Treatment with intravenous dexamethasone before electrocautery tonsillectomy and adenoidectomy is safe, increases early postoperative oral intake, and decreases morbidity. This randomized placebo-controlled cross-over trial assessed the effectiveness of a mandibular advancement appliance (MAA) in managing obstructive sleep apnoea (OSA). Twenty-one adults, with confirmed OSA, were provided with a maxillary placebo appliance and a MAA for 4-6 weeks each, in a randomized order. Questionnaires at baseline and after each appliance assessed bed-partners' reports of snoring severity (loudness and number of nights per week), and patients' daytime sleepiness (Epworth Sleepiness Score, ESS). The Apnoea Hypopnoea Index (AHI) and Oxygen Desaturation Index (ODI) were measured at baseline and with each appliance during single night sleep studies. Seventy-nine per cent of subjects wore their MAA for at least 4 hours at night. Sixty-eight per cent of subjects wore their MAA for 6-7 nights per week. Excessive salivation was the most commonly reported complication. One subject was unable to tolerate the MAA and withdrew from the study. Among the remaining 20 subjects, the MAA produced significantly lower AHI and ODI values than the placebo. However, although the reported frequency and loudness of snoring and the ESS values were lower with the MAA than the placebo, these differences were not statistically significant. When wearing the MAA, 35 per cent of the OSA subjects had a reduction in the pre-treatment ODI to 10 or less, while 33 per cent had an AHI of 10 or less. The MAA was less effective in the subjects with the most severe OSA (pre-treatment ODI > 50 and/or pre-treatment AHI > 50).
One small study failed to find a difference between two surgical techniques, although return to normal diet was more frequent in the group treated by temperature controlled radiofrequency tonsillectomy and adenoidectomy. At present there is still debate as to the criteria required to diagnose significant obstructive sleep apnoea in children. Also the natural history of the condition has not been fully delineated. There is an absence of randomised controlled trials investigating the efficacy of treatment of confirmed obstructive sleep apnoea with adenotonsillectomy in children. Research is required before recommendations for the treatment of obstructive sleep apnoea in children can be formulated. The quality of research in this area could be improved with the use of sleep studies at baseline to determine the extent of severity of sleep apnoea in children who are recruited to studies in this area. Long-term follow up is also required in order to explore the effect of adenotonsillectomy on paediatric sleep apnoea.