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Objective: To determine the effects of adenotonsillectomy as compared with watchful waiting on the middle ear status of children. Study Design: Randomized controlled trial. Methods: We recruited 300 children between 2 and 8 years of age who were selected for adenotonsillectomy according to current medical practice. Excluded from the trial were children with very frequent throat infections (more than 6 per year) or obstructive sleep apnea. Participants were randomly assigned to either adenotonsillectomy or watchful waiting. Main outcome measure was the percentage of children with unilateral or bilateral otitis media diagnosed at the scheduled follow-up visits according to an algorithm combining tympanometry and otoscopy. Results: The percentages of children in the adenotonsillectomy and watchful waiting group diagnosed with otitis media at baseline and at 3, 6, 12, 18, and 24 months were 27.7 versus 30.5, 16.8 versus 25.2, 18.3 versus 21.2, 12.3 versus 15.2, 17.6 versus 15.5, and 14.7 versus 10.3%, respectively ( P < .10). In the subgroup of children selected for adenotonsillectomy predominantly because of recurrent or persistent otitis media, hearing loss, or recurrent upper respiratory tract infections (n = 111) and in the subgroup of children diagnosed with otitis media at inclusion (n = 82), the occurrence of otitis media did not differ significantly between the adenotonsillectomy and watchful waiting group during the entire follow-up period. Conclusion: We conclude that in a large proportion of children selected for adenotonsillectomy according to current medical practice, including those with otitis media or related complaints, no beneficial effect of adenotonsillectomy on middle ear status is to be expected. [ABSTRACT FROM AUTHOR]

Objective To assess the effectiveness of adenotonsillectomy in children with mild symptoms of throat infection or adenotonsillar hypertrophy. Design Open, randomized controlled trial. Setting 21 general hospitals and three academic centers in the Netherlands. Participants 300 children aged 2-8 years requiring adenotonsillectomy. Intervention Adenotonsillectomy compared with watchful waiting. Main outcomes measures Episodes of fever, throat infections, upper respiratory tract infections, and health related quality of life. Results During the median follow up period of 22 months, children in the adenotonsillectomy group 2.97 episodes of fever per person year compared with 3.18 in the watchful waiting group (difference -0.21, 95% confidence interval -0.54 to 0.12), 0.56 throat infections per person year compared with 0.77 (-0.21, -0.36 to -0.06), and 5.47 upper respiratory tract infections per person year compared with 6.00 (-0.53,-0.97 to -0.08). No clinically relevant differences were found for health related quality of life. Adenotonsillectormy was more effective in children with a history of three to six throat infections than in those with none to two. 12 children had surgery related complications. Conclusion Adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy has no major clinical benefits over watchful waiting. [ABSTRACT FROM AUTHOR]

Background: Fever is an important physical sign in infectious diseases in childhood. Daily assessment of fever may be used to monitor the occurrence of infections for research purposes. The infrared tympanic membrane thermometer (ITT) seems ideal for measuring central body temperature. Its accuracy, however, is still debated, and the feasibility of daily temperature measurements with an ITT has not been described. Objective: To determine the accuracy and feasibility of daily infrared tympanic membrane temperature measurements at home. Methods: Tympanic membrane temperature was measured by the Braun Pro 3000, rectal temperature by the Omron MC 63. To establish the accuracy of the ITT, rectal and tympanic membrane temperature measurements were performed in 41 children, aged 2–10 years. To establish the feasibility of daily infrared tympanic temperature measurements at home, parents of 21 children performed daily measurements for 2 weeks. Results: With fever defined as a body temperature of ≥38.0 °C, sensitivity was 93.3%, specificity 92%, positive predictive value 87.5%, negative predictive value 95.8%, and the concordance rate 92.5%. Most of the parents found the instructions for the use of the ITT clear (93%) and the ITT easy to use (86%). During the test period of 2 weeks the technique of the tympanic membrane temperature measurements remained adequate in 93% of the parents. Conclusion: The tympanic membrane temperature measured by the Braun Pro 3000 accurately reflects rectal temperature, validly assesses the presence of fever in children, and is easy to use. The Braun ITT therefore is an adequate tool to assess fever and may be used both in a clinical setting and for research purposes. [Copyright &y& Elsevier]

Objective--To compare demographic and disease-specific characteristics of children included in a trial of the effectiveness of adenotonsillectomy with those of children who although eligible, were not randomized. Material and Methods--Characteristics were compared between (i) randomized children (n=270): (ii) eligible children whose parents immediately decided no to participate (n=243): and (iii) eligible children whose parents were informed about the trial by a member of study team but did not give their informed constant for participation in the trial (n=406]. Results-- Statistically significant but relatively small differences were observed between the groups. Notably, breathing difficulties at night and abnormal appearance of the tonsils were more prevalent among eligible children whose parent immediately refused participation in the trial than in the other two groups. In contrast, cervical lymphadenopathy and previous ENT surgery were less prevalent among eligible children whose parents immediately refused participation in the trail. Conclusion: Fex and relatively small differences were observed randomized and eligible, non-randomized children. The trial population appears to be representative of the relevant patient domain, i.e. children currently undergoing adenotonsillectoy in The Netherland. [ABSTRACT FROM AUTHOR]