Comparison of Preoperative Inhaled Budesonide With Salbutamol on the Respiratory Adverse Effects in Children Undergoing Tonsillectomy
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 87
- Primary Endpoint
- incidence of preoperative respiratory adverse events.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
normal saline
children will receive 0.4 ml of normal saline 0.9 by inhalation 20 minutes preoperatively
Intervention: Saline (Other)
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
Intervention: Salbutamol (Drug)
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
Intervention: Budesonide (Drug)
Outcomes
Primary Outcomes
incidence of preoperative respiratory adverse events.
Time Frame: 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 Outcomes
- frequency of the individual PRAEs(1 year)
Investigators
Ziad Shaban Redwan Helal
Resident Doctor
Assiut University