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NCT06158893 | NOT YET RECRUITING | Preoperative Inhalation of Budesonide and Salbutamol in Children Undergoing Tonsillectomy

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

Assiut University

Information provided by (Responsible Party):

Ziad Shaban Radwan Hilal

Brief Summary:

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

Condition or disease

Preoperative Inhalation of Budesonide and Salbutamol in Children Undergoing Tonsillectomy

Intervention/treatment

Salbutamol

Budesonide

Saline

Phase

PHASE4

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
Estimated Enrollment : 87 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Comparison of Preoperative Inhaled Budesonide With Salbutamol on the Respiratory Adverse Effects in Children Undergoing Tonsillectomy
Actual Study Start Date : 2024-08
Estimated Primary Completion Date : 2025-08
Estimated Study Completion Date : 2025-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 5 Years to 12 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Comparison of Preoperative Inhaled Budesonide With Salbutamol on the Respiratory Adverse Effects in Children Undergoing Tonsillectomy

Location Details

NCT06158893

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