Preoperative Inhalation of Budesonide and Salbutamol in Children Undergoing Tonsillectomy
Conditions
Brief summary
Comparison of preoperative inhaled Budesonide with Salbutamol on the incidence of respiratory adverse effects in children undergoing tonsillectomy
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.
Interventions
DRUGSalbutamol
inhalation anaesthesia
DRUGBudesonide
inhalation anaesthesia
OTHERSaline
saline
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of preoperative respiratory adverse events. | 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| frequency of the individual PRAEs | 1 year | 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) |
Contacts
Primary ContactZiad SR Helal
Outcome results
None listed