Comparison of the efficacy of midazolam nasal spray compared to intranasal midazolam ampoules as part of the pre-operative sedation regimen in children undergoing unilateral inguinal hernia surgery

Comparison of the efficacy of midazolam nasal spray compared to intranasal midazolam ampoules as part of the pre-operative sedation regimen in children undergoing unilateral inguinal hernia surgery , an open-label randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120731010453N6

Enrollment

Registered

2024-12-15

Start date

2024-11-30

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

Unilateral inguinal hernia. Unilateral inguinal hernia, without obstruction or gangrene

Interventions

Intervention 1: Intervention group: Midazolam is administered as a nasal spray at a dose of 0.2-0.3 mg per kilogram. Intervention 2: Control group: The ampoule form of midazolam is administered intran

Eligibility

Sex/Gender

All

Age

1 Years to 8 Years

Inclusion criteria

Inclusion criteria: All children between 1 year and 8 years of age who require intranasal midazolam as sedation prior to unilateral inguinal hernia surgery.

Exclusion criteria

Exclusion criteria: Child with a history of seizures Child with a history of trauma to the head and neck area Drug allergy Parental disapproval

Design outcomes

Primary

Measure	Time frame
Sedation level. Timepoint: Up to 30 minutes after drug administration. Method of measurement: Ramsey sedation scale.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojtaba Shafiekhani

Shiraz University of Medical Sciences

mojtabashafiekhani@gmail.com+98 71 3242 4255

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026