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

NCT ID: NCT06158893

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-31

Study Completion Date

2025-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Preoperative Inhalation of Budesonide and Salbutamol in Children Undergoing Tonsillectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Salbutamol

Intervention Type DRUG

inhalation anaesthesia

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

Group Type ACTIVE_COMPARATOR

Budesonide

Intervention Type DRUG

inhalation anaesthesia

normal saline

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

saline

Interventions

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Salbutamol

inhalation anaesthesia

Intervention Type DRUG

Budesonide

inhalation anaesthesia

Intervention Type DRUG

Saline

saline

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ziad Shaban Redwan Helal

Resident Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Ziad SR Helal

Role: CONTACT

Phone: 01099483963

Email: [email protected]

Other Identifiers

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children undergo Tonsillectomy

Identifier Type: -

Identifier Source: org_study_id