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

Assiut University

Status and phase: Not yet enrolling; Phase 4

Conditions: Preoperative Inhalation of Budesonide and Salbutamol in Children Undergoing Tonsillectomy

Treatments: Other: Saline; Drug: Salbutamol; Drug: Budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT06158893

children undergo Tonsillectomy

Details and patient eligibility

About

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

Full 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.

Enrollment: 87 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 3 patient groups, including a placebo group

salbutamol

Experimental group

Description:

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

Treatment:

Drug: Salbutamol

budesonide

Active Comparator group

Description:

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

Treatment:

Drug: Budesonide

normal saline

Placebo Comparator group

Description:

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

Treatment:

Other: Saline