A randomized, controlled trial of tonsillectomy in periodic fever, aphthous stomatitis, pharyngitis, and adenitis syndrome. Tonsillectomy and adenotonsillectomy for recurrent throat infection in moderately affected children. Effectiveness of adenotonsillectomy in PFAPA syndrome: a randomized study. Adenoidectomy and adenotonsillectomy for recurrent acute otitis media: parallel randomized clinical trials in children not previously treated with tympanostomy tubes. Adenoidectomy versus chemoprophylaxis and placebo for recurrent acute otitis media in children aged under 2 years: randomised controlled trial. Prevention of otitis media by adenoidectomy in children younger than 2 years. The effect of antibiotic therapy on recovery after tonsillectomy in children. A controlled study. Efficacy of tonsillectomy for recurrent throat infection in severely affected children. Results of parallel randomized and nonrandomized clinical trials. Pediatric tonsillotomy with the radiofrequency technique: less morbidity and pain.
We carried out a prospective, randomized, controlled trial to clarify the effect of tonsillectomy on the clinical course of periodic fever, aphthous stomatitis, pharyngitis, and adenitis (PFAPA) syndrome.
                Twenty-six consecutive children (mean age 4.1 years) with at least 5 PFAPA attacks were recruited from 3 tertiary care pediatric hospitals during 1999-2003 and randomly allocated to tonsillectomy or follow-up alone. They were all followed up with symptom diaries for 12 months. Tonsillectomy was allowed after 6 months in the control group if the attacks recurred.
                Six months after randomization all 14 children in the tonsillectomy group and 6/12 children in the control group (50%) were free of symptoms (difference 50%, 95% confidence interval 23% to 75%, P < .001). Tonsillectomy was performed on 5/6 of the patients in the control group who still had symptoms after 6 months. The remaining unoperated child in the control group had recurrences of the fever episodes throughout the follow-up, but the symptoms became less severe, and the parents did not choose tonsillectomy.
                Tonsillectomy appeared to be effective for treating PFAPA syndrome. The fever episodes ceased without any intervention in half of the control subjects. We conclude that although the mechanisms behind this syndrome are unknown, tonsillectomy can be offered as an effective intervention for children with PFAPA. 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 evaluate whether adenotonsillectomy leads to complete resolution in children with PFAPA (periodic fever, aphthous stomatitis, pharyngitis, and cervical adenitis) syndrome.
                Thirty-nine children with PFAPA syndrome were randomized to either adenotonsillectomy (surgery group; n = 19) or expectant management (control group; n = 20). All patients were then invited prospectively to record all PFAPA episodes, and were evaluated clinically every 3 months for 18 months after randomization.
                The proportion of patients experiencing complete resolution was 63% in the surgery group and 5% in the control group (P < .001). The mean (+/- standard deviation) number of episodes recorded during the study period was 0.7 +/- 1.2 in the surgery group and 8.1 +/- 3.9 in the control group (P < .001). The episodes were less severe in the surgery group.
                Adenotonsillectomy is an effective treatment strategy for children with PFAPA syndrome. 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. To evaluate the efficacy of adenoidectomy compared with long term chemoprophylaxis and placebo in the prevention of recurrent acute otitis media in children aged between 10 months and 2 years.
                Randomised, double blind, controlled trial.
                Oulu University Hospital, a tertiary centre in Finland.
                180 children aged 10 months to 2 years with recurrent acute otitis media.
                Adenoidectomy, sulfafurazole (sulphisoxazole) 50 mg/kg body weight, given once a day for six months or placebo. Follow up lasted for two years, during which time all symptoms and episodes of acute otitis media were recorded.
                Intervention failure (two episodes in two months or three in six months or persistent effusion) during follow up, number of episodes of acute otitis media, number of visits to a doctor because of any infection, and antibiotic prescriptions Number of prescriptions, and days with symptoms of respiratory infection.
                Compared with placebo, interventions failed during both the first six months and the rest of the follow up period of 24 months similarly in the adenoidectomy and chemoprophylaxis groups (at six months the differences in risk were 10% (95% confidence interval -9% to 29%) and 18% (-2% to 38%), respectively). No significant differences were observed between the groups in the numbers of episodes of acute otitis media, visits to a doctor, antibiotic prescriptions, and days with symptoms of respiratory infection.
                Adenoidectomy, as the first surgical treatment of children aged 10 to 24 months with recurrent acute otitis media, is not effective in preventing further episodes. It cannot be recommended as the primary method of prophylaxis. To test the effect of adenoidectomy in connection with tympanostomy compared with tympanostomy only in preventing otitis media in children younger than 2 years.
                Prospective trial with randomized and nonrandomized arms.
                Primary care study clinics.
                The study participants were selected from 2497 children who had been enrolled in the Finnish Otitis Media Vaccine Trial at the age of 2 months. A total of 306 children, aged 1 to 2 years, who had experienced recurrent episodes of otitis media were randomized into 2 treatment groups: tympanostomy with or without adenoidectomy. Of the 306 children, 137 were operated on according to random basis (randomized trial). The 169 children whose parents declined participation in the randomized trial were operated on according to the parents' preferences (nonrandomized trial). All children were followed up until 2 years of age. The mean follow-up time was 7 months.
                The rate of acute otitis media episodes.
                The average reduction in the rate of all acute otitis media episodes in the adenoidectomy group was 19% (95% confidence interval [CI], -14% to 43%) among children enrolled in the randomized trial and 25% (95% CI, -13% to 50%) in the nonrandomized trial. The reduction in the randomized trial was mainly due to reduction in the rate of pneumococcal otitis media (58%, 95% CI, 16%-79%).
                In children younger than 2 years, concurrent adenoidectomy during the insertion of tympanostomy tubes does not seem to have a major advantage over the insertion of tympanostomy tubes alone in preventing otitis media. Tonsillectomy continues to be a commonly performed operation in the pediatric age group. The postoperative period is often protracted and characterized by throat and ear pain, intermittent fever, foul odor from the oral cavity, and poor oral intake. Consequently, antibiotics are frequently prescribed in an effort to minimize these symptoms and/or avoid complications such as dehydration or secondary infection of the operative site. However, to our knowledge, no study to date has been performed to demonstrate the efficacy of antibiotic therapy in this setting. At the Children's Hospital of Philadelphia, a prospective, randomized, double-blind study was undertaken in which ampicillin (or placebo) was administered intravenously at the time of surgery and for 12 to 24 hours postoperatively. The children then continued to receive oral amoxicillin therapy (or placebo) for an additional seven days. The patients were then evaluated for the incidence and severity of postoperative symptoms and complications. Intraoperative cultures of the oropharynx and tonsillar tissue, as well as cultures of the tonsillar fossa, were obtained following completion of one week of therapy. Our results indicate that ampicillin sodium/amoxicillin trihydrate therapy is well tolerated and safe in the nonallergic child and is effective in minimizing fever and other troublesome postoperative symptoms, such as pain, lassitude, mouth odor, and poor oral intake after tonsillectomy. We studied the efficacy of tonsillectomy, or tonsillectomy with adenoidectomy, in 187 children severely affected with recurrent throat infection. Ninety-one of the children were assigned randomly to either surgical or nonsurgical treatment groups, and 96 were assigned according to parental preference. In both the randomized and nonrandomized trials, the effects of tonsillectomy and of tonsillectomy with adenoidectomy were similar. By various measures, the incidence of throat infection during the first two years of follow-up was significantly lower (P less than or equal to 0.05) in the surgical groups than in the corresponding nonsurgical groups. Third-year differences, although in most cases not significant, also consistently favored the surgical groups. On the other hand, in each follow-up year many subjects in the nonsurgical groups had fewer than three episodes of infection, and most episodes among subjects in the nonsurgical groups were mild. Of the 95 subjects treated with surgery, 13 (14 per cent) had surgery-related complications, all of which were readily managed or self-limited. These results warrant the election of tonsillectomy for children meeting the trials' stringent eligibility criteria, but also provide support for nonsurgical management. Treatment for such children must therefore be individualized. To compare two techniques for pediatric tonsil surgery with respect to pain and postoperative morbidity. The two methods were the partial tonsil resection using radiofrequency (RF) technique (tonsillotomy [TT]) versus traditional tonsillectomy (TE).
                Prospective clinical randomized study in one tertiary care ENT clinic and two secondary care clinics.
                One hundred fifty children, between 5 and 15 years of age, were randomized to either TT with RF using the Surgitron Ellman, 1.7 MHz, or regular TE. Randomization was performed from the waiting list, including children with both a history of obstructive problems and recurrent tonsillitis. The TT was performed with a specially made sling electrode using a cut/coagulation mode.
                Forty-nine children were operated on with TT and 43 with TE. There was significantly less bleeding in the TT group, although two cases of primary postoperative bleeding occurred among the TT children and one in the TE group. The pain recordings showed significantly less pain for the TT children from the second hour postoperatively onward, and the TT children were pain free and in school 3 days earlier than the TE group. The TT group had less need of the prescribed drugs (diclofenac and paracetamol). After 9 days, 73% of the TT children were completely healed, but only 31% of the TE children. By that time, the TE children had lost a mean of 660 g, and the TT children had gained 127 g. The effect on snoring was the same for both groups.
                RF appears to be a safe and reliable method for tonsil surgery with much less postoperative morbidity than regular TE.
The trials included in this review reported follow up at 18 and six months respectively but it is well-established that children with PFAPA recover spontaneously and treatment can be administered to try and reduce the severity of individual episodes. Therefore, the parents and carers of children with PFAPA must weigh the risks and consequences of surgery (hospitalisation, a predictable period of time postoperatively away from school/nursery, the risks of surgery) against the alternative of a finite period of recurrent episodes of disease at predictable intervals, potentially requiring time off school and the regular use of medication. It is uncertain whether adenoidectomy combined with tonsillectomy adds any additional benefit to tonsillectomy alone.