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

NCT06158893 | Unknown Phase 4 FDA Drug

• 1 other identifier: children undergo Tonsillectomy
• Study Type: interventional
• Target: 87
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Preoperative Inhalation of Budesonide and Salbutamol in Children Undergoing Tonsillectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• frequency of the individual PRAEs

  1 year

Study Arms (3)

salbutamol

EXPERIMENTAL

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

budesonide

ACTIVE COMPARATOR

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

normal saline

PLACEBO COMPARATOR

children will receive 0.4 ml of normal saline 0.9 by inhalation 20 minutes preoperatively

Other: Saline

Interventions

Salbutamol DRUG

inhalation anaesthesia

salbutamol

Budesonide DRUG

inhalation anaesthesia

budesonide

Saline OTHER

saline

normal saline

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children scheduled for elective tonsillectomy with or without adenoidectomy, grommets cautery of inferior turbinates.
• Age more than or equal 5 years and less than or equal to 12 years.
• Both genders
• No obvious abnormalities in preoperative ECG, blood routine electrolytes and other tests.
• ASA class 1

You may not qualify if:

• Patients with Known hypersensitivity to any of the drugs that would be used in the study
• Patients that are immunologically compromised
• Sleep apnea syndrome or difficult airway
• Pre-existing hypoxemia is SpO2 \< 90%
• History of adverse events with prior sedation or patients who had taken any sedative drugs within the last 24 hours.
• Parents refusal

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Albuterol; Budesonide; Sodium Chloride

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Ziad SR Helal

CONTACT

01099483963; elhelal2007@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 6, 2023

Record last verified: 2023-11