The effectiveness of adenotonsillectomy in childre

Completed

Conditions: Throat infections, Adenotonsillectomy, Adenotonsillar hypertrophy
Infections and Infestations
Acute upper respiratory infections of multiple and unspecified sites

Registration Number: ISRCTN04973569

Lead Sponsor: niversity Medical Centre Utrecht (UMCU) (Netherlands)

Brief Summary: Not available

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 (three 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 seven or more throat infections in the preceding year, or five or more in each of the two preceding years, or three or more in each of the three preceding years (Paradise criteria)
2. High suspicion of obstructive sleep apnoea, i.e. Brouillette's Obstructive Sleep Apnoea (OSA) score of more than 3.5
3. Down's syndrome
4. Craniofacial malformation, such as cleft palate
5. Documented immunodeficiency, other than Immunoglobulin A (IgA) or Immunoglobulin G subclass two (IgG2) deficiencies

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of fever (a temperature of 38.0°C or higher) for at least one day, measured in number of episodes and days. An episode was considered finished when at least one day was without fever. New episodes were those occurring after a fever-free interval of at least seven days.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures were:<br>1. Throat infections<br>2. Sore throat days and episodes<br>3. Upper respiratory infections<br>4. Otitis media<br>5. Sleeping and eating pattern<br>6. Length and weight<br>7. Absence from day-care or school due to upper respiratory infections<br>8. Health-related quality of life<br>9. Costs<br>10. Immunological parameters<br>11. Oropharyngeal microbial flora<br><br>Secondary outcomes were measured during follow-up visits at 3, 6, 12, 18 and 24 months.