Intranasal Midazolam for Preanasthetic Sedation for Preschool Children Undergoing Adenotonsillectomy.

Sohag University

Status: Enrolling

Conditions: Adenotonsillar Hypertrophy

Treatments: Drug: intranasal normal saline for preanasthetic sedation for Adenotonsillectomy; Drug: intranasal midazolam for preanasthetic sedation for Adenotonsillectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07045597

Soh-Med--25-3-08MS

Details and patient eligibility

About

This study aims to evaluate the effectiveness of Intranasal Midazolam as preanasthetic sedation for preschool children (2-6)y undergoing adenotonsillectomy.

Enrollment: 100 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

intranasal normal saline for preanasthetic sedation for Adenotonsillectomy

Placebo Comparator group

Description:

Patient will receive intranasal normal saline equivalent volume who take midazolam intranasal by dose 1 ml saline by insulin syringe as a control group

Treatment:

Drug: intranasal normal saline for preanasthetic sedation for Adenotonsillectomy

intranasal midazolam for preanasthetic sedation for Adenotonsillectomy

Active Comparator group

Description:

Patient will receive intranasal midazolam by dose 0.2 mg/kg

Treatment:

Drug: intranasal midazolam for preanasthetic sedation for Adenotonsillectomy