Skip to content

Comparison of midazolam and dexmedetomidine as oral premedication in dental treatment with sedation

Comparison of midazolam and dexmedetomidine as oral premedication on emergence agitation control in deep intravenous sedation in pediatric dental treatment

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240806062670N1
Enrollment
32
Registered
2025-01-12
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

emergence agitation in recovery in deep dental sedation.

Interventions

Intervention 1: Intervention group: In the first session, half of the samples will receive dexmedetomidine (Iran Elixir Company) at a dose of 4 µg/kg orally as a premedication. The drug will be prescr

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years

Inclusion criteria

Inclusion criteria: 2–6-year-old children uncooperative definitely negative or negative Frankl scores ASA I, according to the American Society of Anesthesiology (ASA) referred to the Pediatric Dentistry Fellowship Clinic at the Dental School of Shahid Beheshti University of Medical Sciences required at least 2 similar dental treatment visits.

Exclusion criteria

Exclusion criteria: History of cold in the last 14 days Patients with large tonsils Any drug sensitivity to sedatives

Design outcomes

Primary

MeasureTime frame
Emergence agitation in recovery using PAED scale. Timepoint: T0 after entering recovery, T1 five minutes after entering recovery, T2 fifteen minutes after recovery, T3 thirty minutes after recovery, T4 sixty minutes after recovery. Method of measurement: agitation measurement index in recovery: pediatric anesthesia emergence delirium scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElmira Niazi

Shahid Beheshti University of Medical Sciences

elmiraniazi90@gmail.com+98 21 2217 5351

Outcome results

None listed

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