Intranasal Midazolam for Preanasthetic Sedation for Preschool Children Undergoing Adenotonsillectomy.
Not Applicable
Recruiting
- Conditions
- Adenotonsillar Hypertrophy
- Interventions
- Drug: intranasal normal saline for preanasthetic sedation for AdenotonsillectomyDrug: intranasal midazolam for preanasthetic sedation for Adenotonsillectomy
- Registration Number
- NCT07045597
- Lead Sponsor
- Sohag University
- Brief Summary
This study aims to evaluate the effectiveness of Intranasal Midazolam as preanasthetic sedation for preschool children (2-6)y undergoing adenotonsillectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- pediatric patient of age 2-6 y
- ASA I-II children
- child scheduled for elective adenoidectomy , tonsillectomy and adenotonsillectomy
Exclusion Criteria
- Parent refusal .
- Allergy to any of the drug included in this study
- Nasal infection , allergy and pathology
- Mentally affected children , neurological disable .
- Blood disesases and any other contraindications of surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intranasal normal saline for preanasthetic sedation for Adenotonsillectomy intranasal normal saline for preanasthetic sedation for Adenotonsillectomy Patient will receive intranasal normal saline equivalent volume who take midazolam intranasal by dose 1 ml saline by insulin syringe as a control group intranasal midazolam for preanasthetic sedation for Adenotonsillectomy intranasal midazolam for preanasthetic sedation for Adenotonsillectomy Patient will receive intranasal midazolam by dose 0.2 mg/kg
- Primary Outcome Measures
Name Time Method sedative effect of preanesthetic Midazolam 5 minutes,10 minutes and 15 minutes preoperative Glasgow coma scale
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of midazolam in preanesthetic sedation for adenotonsillar hypertrophy in children?
How does intranasal midazolam compare to oral midazolam for preanesthetic sedation in preschool children undergoing adenotonsillectomy?
What biomarkers predict optimal sedation response to intranasal midazolam in 2-6 year old patients with obstructive sleep apnea due to adenotonsillar hypertrophy?
What are the potential adverse events associated with intranasal midazolam administration in pediatric populations and how are they managed?
Are there alternative benzodiazepine delivery methods or combination therapies being evaluated for preoperative sedation in children with adenotonsillar hypertrophy?
Trial Locations
- Locations (1)
Sohag University Hospital
🇪🇬Sohag, Egypt
Sohag University Hospital🇪🇬Sohag, EgyptMagdy M Amin, ProfessorContact01090801900