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Comparison of the Effect of Intranasal Dexmedetomidine and Midazolam on Child’s Sedation and Cooperation

Evaluation and Comparison of the Effect of Intranasal Dexmedetomidine and Midazolam on Child’s Sedation and Cooperation During IV Cannulation Prior to Dental Anesthesia and Heart Rate Changes During Laryngoscopy: A Randomized Controlled Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100621004224N39
Enrollment
60
Registered
2026-05-12
Start date
2026-05-20
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Anxiety. Anxiety disorder due to known physiological condition

Interventions

Intervention 1: The first intervention group will receive intranasal dexmedetomidine (Exir Company, Iran) at a dose of 1.5 µg/kg body weight, administered 20 minutes before the induction of anesthesia

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 5 Years

Inclusion criteria

Inclusion criteria: Informed Consent Healthy children 3–5 years of age Need for general anesthesia for dental treatments

Exclusion criteria

Exclusion criteria: Having contraindications for general anesthesia and nasotracheal intubation on the day of procedure/surgery History of hypersensitivity to midazolam or dexmedetomidine Use of sedative or anxiolytic medications within 24 hours prior to the study Severe obesity or severe underweight

Design outcomes

Primary

MeasureTime frame
Anxiety. Timepoint: The beginning of the study and the end of the study. Method of measurement: Base on Modified Yale Preoperative Anxiety Scale.;Sedation during venipuncture. Timepoint: 20 minutes after drug administration, at the same time as venipuncture. Method of measurement: Base on University of Michigan Sedation Scale.;Heartbeat. Timepoint: Before and after laryngoscopy. Method of measurement: Using monitoring.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNastaran Kaviani

Esfahan University of Medical Sciences

n.kaviani@yahoo.com+98 31 3792 3071

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026