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The effectiveness of adenotonsillectomy in children.

The effectiveness of adenotonsillectomy in children NATAN project: Nederlands AdenoTonsillectomie project, Tonsillectomy & Adenoidectomy in the Netherlands.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26888
Enrollment
300
Registered
2007-03-26
Start date
2000-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Throat infections

Interventions

Adenotonsillectomy within 6 weeks versus watchful waiting. During the study, the child's temperature was measured daily with a validated infrared tympanic membrane thermometer with an electronic devic
i.e. sore throat, pain/difficulty at swallowing, cough, rhinorrhea, earache and otorrhea. They also noted absence from day-care or school due to upper respiratory infections, and resource use such as

Sponsors

University Medical Center Utrecht PO box 85500 3508 GA Utrecht The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

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

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); 2. High suspicion of obstructive sleep apnoea, i.e. Brouillette¡¦s OSA-score of more than 3.5; 3. Down¡¦s syndrome; 4. Craniofacial malformation, such as cleft palate; 5. Documented immunodeficiency, other than IgA or IgG2 deficiencies.

Design outcomes

Primary

MeasureTime frame
Incidence of fever episodes defined as a body-temperature of 38.0 C or higher for at least one day.

Secondary

MeasureTime frame
Secondary outcome measures were: 1. Throat infections; 2. Sore throat days and episodes; 3. Upper respiratory infections; 4. Otitis media; 5. Sleeping and eating pattern; 6. Length and weight; 7. Absence from day-care or school due to upper respiratory infections; 8. Health-related quality of life; 9. Costs; 10. Immunological parameters; 11. Oropharyngeal microbial flora.

Contacts

Public ContactAnne G.M. Schilder

University Medical Center Utrecht Wilhelmina Children's Hospital Department of Otorhinolaryngology PO Box 85090

A.Schilder@umcutrecht.nl+31 (0)30 2504004

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)