Comparison of Preoperative Inhaled Budesonide With Salbutamol on the Respiratory Adverse Effects in Children Undergoing Tonsillectomy

Assiut University87 enrolled

Overview

Comparison of preoperative inhaled Budesonide with Salbutamol on the incidence of respiratory adverse effects in children undergoing tonsillectomy

Comparison of preoperative inhaled Budesonide with Salbutamol on the incidence of respiratory adverse effects in children undergoing tonsillectomy Adenotosillectomy is routinely performed for children with sleep disordered breathing or recurrent infectious tonsillitis. Although the safety of the pediatric anesthesia is constantly improving, a substantial proportion of children undergoing tonsillectomies experience pre operative respiratory adverse events with a prevalence up to 50% in children with at least one risk factor. Both minor adverse effects such as oxygen desaturation airway, obstruction coughing or wheezing and the major events such as laryngospasm and/ or bronchospasm occur more commonly undergoing tonsillectomy compared with other non airway surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Preoperative Inhalation of Budesonide and Salbutamol in Children Undergoing Tonsillectomy

Interventions

SalbutamolDRUG

inhalation anaesthesia

BudesonideDRUG

inhalation anaesthesia

SalineOTHER

saline

Eligibility

Sex: ALLMin age: 5 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. children scheduled for elective tonsillectomy with or without adenoidectomy, grommets cautery of inferior turbinates. 2. Age more than or equal 5 years and less than or equal to 12 years. 3. Both genders 4. No obvious abnormalities in preoperative ECG, blood routine electrolytes and other tests. 5. ASA class 1 Exclusion Criteria: 1. Patients with Known hypersensitivity to any of the drugs that would be used in the study 2. Patients that are immunologically compromised 3. Sleep apnea syndrome or difficult airway 4. Pre-existing hypoxemia is SpO2 \< 90% 5. History of adverse events with prior sedation or patients who had taken any sedative drugs within the last 24 hours. 6. Parents refusal

Outcomes

Primary Outcomes

incidence of preoperative respiratory adverse events.

Will be the incidence of preoperative respiratory adverse events. events will be reported by the attending an anesthetist or PACU nurse on a dedicated data collection sheet and will be recorded against the phase of anesthesia (induction, maintenance, emergency, or recovery) during which the event occurred

Time frame: 1 year

Secondary Outcomes

frequency of the individual PRAEs

Will be the frequency of the individual PRAEs, incidence of PRAEs during the induction and recovery periods, recovery time (the time from the end of surgery to discharge from PACU)

Time frame: 1 year

Central Contacts

Ziad SR Helal

CONTACT

01099483963 elhelal2007@gmail.com

Data from ClinicalTrials.gov

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