effects of propofol/apotel and propofol/fentanyl on dental sedation of 2-6 years old uncooperative children

Comparison of the effects of propofol/fentanyl and propofol/apotel for IV sedation during the dental treatment of 2-6 years old precooperative pediatric patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20221203056700N1

Enrollment

Registered

2023-01-28

Start date

2023-02-09

Completion date

Unknown

Last updated

2023-02-07

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: Intervention group1: intravenous administration of 15 mg/kg apotel ( 1g/6.7ml ) + 2 mg/kg propofol (10mg/cc Fresenius C.,Austria). Intervention 2: Intervention group2: intravenous admi

Eligibility

Sex/Gender

All

Age

2 Years to 6 Years

Inclusion criteria

Inclusion criteria: 2-6 years old children Uncooperative Need to at least two same and symmetric treatment session ASA 1 health status

Exclusion criteria

Exclusion criteria: The age under 2 and above 6 years Cooperative Lack of similar treatment needs ASA 2 and more

Design outcomes

Primary

Measure	Time frame
Conscious sedation. Timepoint: Venipuncture, local anesthesia and Every 15 minutes. Method of measurement: Houpt scale.	—

Secondary

Measure	Time frame
SPO2. Timepoint: Venipuncture, local anesthesia and every 15 minutes. Method of measurement: Pulse oximeter.;Heart rate. Timepoint: Venipuncture, local anesthesia and every 15 minutes. Method of measurement: Pulse oximeter.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoud Fallahinejad Ghajari

Shahid Beheshti University of Medical Sciences

masfalnegh@sbmu.ac.ir+98 21 2240 3080

Outcome results

None listed

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