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

Phase 4

Not yet recruiting

• Conditions: Preoperative Inhalation of Budesonide and Salbutamol in Children Undergoing Tonsillectomy
• Interventions: Other: Saline; Drug: Salbutamol; Drug: Budesonide

• Registration Number: NCT06158893
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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 Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-11-28
• Last Update Submitted: 2023-11-28
• Study First Posted: 2023-12-06
• Last Update Posted: 2023-12-06
• Study Start: 2024-08
• Primary Completion: 2025-08
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline	Saline	children will receive 0.4 ml of normal saline 0.9 by inhalation 20 minutes preoperatively
salbutamol	Salbutamol	children will receive 0.15 milligram per kilogram of salbutamol diluted with normal saline to a total volume of 4 ml by inhalation 20 minutes preoperatively
budesonide	Budesonide	children will receive 0.5 milligram per kilogram of budesonide diluted with normal saline to a total volume of 4 ml by inhalation 20 minutes preoperatively

Primary Outcome Measures

Name	Time	Method
incidence of preoperative respiratory adverse events.	1 year	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

Secondary Outcome Measures

Name	Time	Method
frequency of the individual PRAEs	1 year	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)