Status:
COMPLETED
Effect of Intranasal Midazolam Versus Ketamine Midazolam Combination as a Premedication on the Occurrence of Postoperative Respiratory Adverse Events
Lead Sponsor:
Kasr El Aini Hospital
Conditions:
Tonsillectomy
Adenoidectomy
Eligibility:
All Genders
3-12 years
Phase:
PHASE3
Brief Summary
The aim of this study is to investigate the effect of addition of intranasal ketamine to midazolam compared to midazolam alone as a premedication on the occurrence of PRAEs
Detailed Description
Perioperative respiratory adverse events (PRAEs) are the most common complication during pediatric anesthesia furthermore, most children presenting for AT have sleep-disordered breathing and obstructi...
Eligibility Criteria
Inclusion
- Children both sexes male and female.
- Age from 3 to 12 years old.
- ASA grade I, II.
- undergoing elective AT procedures.
Exclusion
- Congenital heart diseases (cyanotic and a cyanotic).
- Congenital syndromes affecting airway anatomy such as Pierre-Robin syndrome and Down syndrome.
- Severe lung diseases affecting either lung tissue such as pulmonary cystic fibrosis and idiopathic pulmonary fibrosis or affecting lung circulation such as pulmonary hypertension with marked limitation of Physical activity or inability to carry out any physical activity according to NHYA classification.
- Recent upper respiratory tract infection (less than two weeks).
- Neuromuscular diseases including cerebral palsy and epilepsy.
Key Trial Info
Start Date :
November 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06122948
Start Date
November 4 2023
End Date
October 10 2024
Last Update
October 15 2024
Active Locations (1)
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1
Cairo university hospitals, kasralainy
Cairo, Egypt, 11559