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Comparative evaluation of the sedative effects of Intra-Venous Propofol / Fentanyl combination Vs. Ketamine / Midazolam combination for uncooperative children undergoing dental procedures.

Comparative evaluation of the sedative effects of Intra-Venous Propofol / Fentanyl combination Vs. Ketamine / Midazolam combination for uncooperative 2-6 year old children undergoing dental procedures.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20211123053154N1
Enrollment
24
Registered
2022-04-03
Start date
2022-01-05
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Dental treatment of uncooperative children under sedation conditions.

Interventions

Intervention 1: In group AB, combination of Fentanyl (dose: 1µgr/kg) and Propofol (dose: 2 mg/kg) will be injected in the intervention phase and the first session of dental treatment for sedation indu

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: Uncooperative 2-6 years old children Patient is in ASA I Patient requires at least two similar dental procedures with local anesthesia

Exclusion criteria

Exclusion criteria: Patient with systemic disorder or allergic/asthmatic history Patient with a cold or airway obstruction during dental procedure Patient with medical advice to stop the sedative drugs

Design outcomes

Primary

MeasureTime frame
The level of child's cooperation. Timepoint: Before dental treatment, during dental treatment and after dental treatment. Method of measurement: Observation and based on Houpt Behavioral Scale.;Heart Rate. Timepoint: Before dental treatment, during dental treatment and after dental treatment. Method of measurement: Pulse oximeter device made by the Alborz company.;Atrial oxygen saturation or Spo2. Timepoint: Before dental treatment, during dental treatment and after dental treatment. Method of measurement: Pulse oximeter device made by the Alborz company.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Esmaeilzadeh

Shahid Beheshti University of Medical Sciences

dr.m.esmaeilzadeh@sbmu.ac.ir+98 21 4496 9962

Outcome results

None listed

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