Comparing the effects of intranasal administration of midazolam and dexmedetomidine As premedication in reducing anxiety and sedation in children

Comparing of the effects of intranasal administration of midazolam and dexmedetomidine premeditations in reducing anxiety and sedation of children candidates for inguinal hernia surgery

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240713062419N1

Enrollment

Registered

2024-11-28

Start date

2024-09-22

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

Condition 1: Hernia Surgery. Condition 2: Inguinal Hernia. Unilateral inguinal hernia, without obstruction or gangrene Bilateral inguinal hernia, without obstruction or gangrene

Interventions

Intervention 1: Intervention group: Intranasal dexmedetomidine 1 microgram per kilogram. Intervention 2: Control group: Intranasal Midazolam 0.2 milligram per kilogram.

Eligibility

Sex/Gender

All

Age

2 Years to 10 Years

Inclusion criteria

Inclusion criteria: Children aged 2 to 10 Candidate for Inguinal Hernia surgery American Society of Anesthesiologists (ASA) Classification of Patient's I and II class

Exclusion criteria

Exclusion criteria: Dissatisfaction Allergy to drugs used for study Nasal Pathologies (like tumors, polyps, epistaxis,...) Upper respiratory tract infections Any mental disorder Any Neurologic disorder Heart Rate below 80

Design outcomes

Primary

Measure	Time frame
Anxiety Score. Timepoint: At the time of drug administration and then every 5 minutes until 30 minutes. Method of measurement: Anxiety Score based on Akin et al Anxiety Score.;Sedation Score. Timepoint: At the time of drug administration and then every 5 minutes until 30 minutes. Method of measurement: Sedation Score by using Modified Observers Assessment of Alertness/Sedation Scale (MOAA/S).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Sabzevari

Mashhad University of Medical Sciences

SabzevariA@mums.ac.ir+98 51 3871 3801

Outcome results

None listed

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