Intranasal Midazolam for Preanasthetic Sedation for Preschool Children Undergoing Adenotonsillectomy.
1 other identifier
interventional
100
1 country
1
Brief Summary
This study aims to evaluate the effectiveness of Intranasal Midazolam as preanasthetic sedation for preschool children (2-6)y undergoing adenotonsillectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 13, 2025
CompletedFirst Submitted
Initial submission to the registry
June 14, 2025
CompletedFirst Posted
Study publicly available on registry
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2025
CompletedJuly 1, 2025
June 1, 2025
7 months
June 14, 2025
June 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
sedative effect of preanesthetic Midazolam
Glasgow coma scale
5 minutes,10 minutes and 15 minutes preoperative
Study Arms (2)
intranasal normal saline for preanasthetic sedation for Adenotonsillectomy
PLACEBO COMPARATORPatient 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
ACTIVE COMPARATORPatient will receive intranasal midazolam by dose 0.2 mg/kg
Interventions
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
preschool children that will undergo adenotonsillectomy will receive intranasal midazolam by dose 0.2 mg/kg
Eligibility Criteria
You may qualify if:
- pediatric patient of age 2-6 y
- ASA I-II children
- child scheduled for elective adenoidectomy , tonsillectomy and adenotonsillectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohag Universitylead
Study Sites (1)
Sohag University Hospital
Sohag, Egypt
Related Publications (3)
Korsch BM. The child and the operating room. Anesthesiology. 1975 Aug;43(2):251-7. doi: 10.1097/00000542-197508000-00010. No abstract available.
PMID: 1098522BACKGROUNDRochette A, Julia JM, Evrard O, Ricard C, Jullien Y, Du Cailar J. [Intramuscular premedication with midazolam in infants and children]. Ann Fr Anesth Reanim. 1984;3(5):346-50. doi: 10.1016/s0750-7658(84)80071-4. French.
PMID: 6497079BACKGROUNDRita L, Seleny FL, Mazurek A, Rabins SY. Intramuscular midazolam for pediatric preanesthetic sedation: a double-blind controlled study with morphine. Anesthesiology. 1985 Nov;63(5):528-31. doi: 10.1097/00000542-198511000-00009. No abstract available.
PMID: 2932039BACKGROUND
Central Study Contacts
Ahmed E Abdelrahman, Professor
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident, Department of Anesthesia, Intensive Care and Pain management, Faculty of Medicine, Sohag University
Study Record Dates
First Submitted
June 14, 2025
First Posted
July 1, 2025
Study Start
March 13, 2025
Primary Completion
October 15, 2025
Study Completion
October 15, 2025
Last Updated
July 1, 2025
Record last verified: 2025-06