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Comparison Between the Effect of Nebulized Budesonide and Intranasal Budesonide Spray on Children With Adenotonsillar Hypertrophy: A Randomized Controlled Clinical Trial
Budesonide is one of the most common drugs uesd in children with adenotonsillar hypertrophy. This study aim to evaluate the efficacy of a short course of budesonide inhalation suspension via transnasal nebulization in children with adenotonsillar hypertrophy. The second aim is to compare budesonide inhalation suspension with budesonide aqueous nasal spray in adenotonsillar hypertrophy treatment.
Details
| Lead sponsor | Second Xiangya Hospital of Central South University |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 100 |
| Start date | 2022-04 |
| Completion | 2024-09 |
Conditions
- Snoring
- Mouth Breathing
Interventions
- Nebulized Budesonide
- Intranasal Budesonide Spray
Primary outcomes
- Adenoid Size — 1 month
Children's adenoid size will be estimated from lateral neck X-ray film based on the adenoidal/nasopharyngeal ratio and from nasal endoscopy based on the ratio of adenoid blocking posterior nostril. Lateral neck X-ray film and nasal endoscopy will be performed before and after the 1-month course. - Clinical responses including 9 symptoms (hard to awaken, witnessed apnea, breathing difficulties, snoring, sweating, mouth breathing, awakenings, restless sleep, wetting the bed) — 1 month
Children's parents will be required to complete a questionnaire about 9 symptoms at diagnosis and after 1 month of therapy. Answers were scored are on a scale of 0 = never to 4 = most of the time.
Countries
China