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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
use 0.5mg/2ml Pulmicort Respules BIS QD and oral montelukast sodium chewable tablets 4mg QD
nasal spray 100μg QD and oral montelukast sodium chewable tablets 4mg QD
Department of Otolaryngology, Second Xiangya Hospital, Central South University
Changsha, Hunan, China
Adenoid Size
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.
Time frame: 1 month
Clinical responses including 9 symptoms (hard to awaken, witnessed apnea, breathing difficulties, snoring, sweating, mouth breathing, awakenings, restless sleep, wetting the bed)
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.
Time frame: 1 month
Tonsillar Size
estimation of oropharyngeal examination before and after the therapy.
Time frame: 1 month
Pediatric Sleep Questionnaire(PSQ) Score
Children's parents will be required to complete the PSQ questionnaire at diagnosis and after 1 month of therapy.
Time frame: 1 month
Obstructive Sleep Apnea Questionnaire(OSA-18) Score
Children's parents will be required to complete the OSA-18 questionnaire at diagnosis and after 1 month of therapy.
Time frame: 1 month
Polysomnography
Children's sleep will be estimated from polysomnography based on the apnea-hypopnea index, obstructive apnea index, time with oxygen saturation below 90% and minimum oxygen saturation value.
Time frame: 1 month
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Lung function
Children's airway ventilation function will be estimated from lung function examination based on the FEV1/FVC value.
Time frame: 1 month
Nasal nitric oxide
Children's nasopharyngeal inflammation will be estimated based on the nasal nitric oxide value.
Time frame: 1 month