Intranasal Midazolam for Preanasthetic Sedation for Preschool Children Undergoing Adenotonsillectomy.

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

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Key information

Conditions

Adenotonsillar Hypertrophy

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University Hospital

Sohag, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intranasal normal saline for preanasthetic sedation for Adenotonsillectomy

Drug

preschool children that will undergo adenotonsillectomy 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

Drug

preschool children that will undergo adenotonsillectomy will receive intranasal midazolam by dose 0.2 mg/kg

Primary outcomes

sedative effect of preanesthetic Midazolam

Time frame: 5 minutes,10 minutes and 15 minutes preoperative

Glasgow coma scale

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jul 1, 2025
Registry last updated: May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed