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Comparison of preoperative inhaled Budesonide with Salbutamol on the incidence of respiratory adverse effects in children undergoing tonsillectomy
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| salbutamol | Experimental | 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 |
|
| budesonide | Active Comparator | 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 |
|
| normal saline | Placebo Comparator | children will receive 0.4 ml of normal saline 0.9 by inhalation 20 minutes preoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salbutamol | Drug | inhalation anaesthesia |
| |
| Budesonide |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of preoperative respiratory adverse events. | 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| frequency of the individual PRAEs | 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) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziad SR Helal | Contact | 01099483963 | 002 | elhelal2007@gmail.com |
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| Drug |
inhalation anaesthesia |
|
| Saline | Other | saline |
|
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D019819 | Budesonide |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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