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Intranasal Midazolam for Preanasthetic Sedation for Preschool Children Undergoing Adenotonsillectomy.

Intranasal Midazolam for Preanasthetic Sedation for Preschool Children Undergoing Adenotonsillectomy.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07045597
Enrollment
100
Registered
2025-07-01
Start date
2025-03-13
Completion date
2025-10-15
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenotonsillar Hypertrophy

Brief summary

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

Interventions

DRUGintranasal normal saline for preanasthetic sedation for Adenotonsillectomy

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

DRUGintranasal midazolam for preanasthetic sedation for Adenotonsillectomy

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

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
sedative effect of preanesthetic Midazolam5 minutes,10 minutes and 15 minutes preoperativeGlasgow coma scale

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026