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The effectiveness of adenotonsillectomy in children.

Completed
Conditions
1. Throat infections
<br /> 2. adenenotonsillar hypertrophy
<br /> 3. adenotonsillectomy.
Registration Number
NL-OMON26888
Lead Sponsor
niversity Medical Center UtrechtPO box 855003508 GA UtrechtThe Netherlands
Brief Summary

1. van Staaij BK, van den Akker EH, Rovers MM, Hordijk GJ, Hoes AW, Schilder AG. Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial. BMJ. 2004 Sep 18;329(7467):651. <br> 2. Arch Otolaryngol Head Neck Surg. 2007 Nov;133(11):1083-8.<br>

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
300
Inclusion Criteria

Children aged 2 to 8 years indicated for adenotonsillectomy according to current medical practice. These included children with recurrent throat infections (3 or more episodes per year) or other indications such as obstructive complaints or recurrent upper respiratory infections.

Exclusion Criteria

Children with:

1. A history of 7 or more throat infections in the preceding year, or 5 or more in each of the two preceding years, or 3 or more in each of the 3 preceding years (Paradise criteria);

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of fever episodes defined as a body-temperature of 38.0 C or higher for at least one day. <br>
Secondary Outcome Measures
NameTimeMethod
Secondary outcome measures were:<br /><br>1. Throat infections;<br /><br>2. Sore throat days and episodes;<br /><br>3. Upper respiratory infections; <br /><br>4. Otitis media;<br /><br>5. Sleeping and eating pattern;<br /><br>6. Length and weight;<br /><br>7. Absence from day-care or school due to upper respiratory infections;<br /><br>8. Health-related quality of life;<br /><br>9. Costs;<br /><br>10. Immunological parameters;<br /><br>11. Oropharyngeal microbial flora.<br>
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