Comparison of Preoperative Inhaled Budesonide With Salbutamol on the 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

Study Overview

• Status: Not yet recruiting
• Conditions: Preoperative Inhalation of Budesonide and Salbutamol in Children Undergoing Tonsillectomy
• Intervention / Treatment: Drug: Salbutamol; Drug: Budesonide; Other: Saline

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 Type: Interventional
• Enrollment (Estimated): 87
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ziad SR Helal; Phone Number: 002 01099483963; Email: elhelal2007@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Salbutamol; inhalation anaesthesia
Active Comparator: 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	Drug: Budesonide; inhalation anaesthesia
Placebo Comparator: normal saline; children will receive 0.4 ml of normal saline 0.9 by inhalation 20 minutes preoperatively	Other: Saline; saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Budesonide; Albuterol
• Other Study ID Numbers: children undergo Tonsillectomy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes