Evaluation of propofol / ketorolac / Apotel sedation with intravenous propofol / fentanyl in dental treatment of uncooperating children

Comparing the effect of propofol/ketorolac/Apotel with propofol / Fentanyl IV sedation in dental treatments of 2-6 years old uncooperative children

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090506001882N11

Enrollment

Registered

2023-01-22

Start date

2023-02-04

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 group: Intravenous injection of 1mg/kg Propofol(10mg/cc Fresenius Co., Austria)/0.5mg/kg Ketorolac( )/20mg/kg APOTEL( ). Intervention 2: Intervention group: Intravenous in

Eligibility

Sex/Gender

All

Age

2 Years to 6 Years

Inclusion criteria

Inclusion criteria: Be in the negative group of Frankel's behavioral classification. Requires at least 2 similar treatment sessions . Be in the ASAI group. Be 2 to 6 years old.

Exclusion criteria

Exclusion criteria: Suffering Systemic Disease. Colds during in treatment session. Non-prescription medication including allergies and treatment needs different from protocol

Design outcomes

Primary

Measure	Time frame
Conscious sedation. Timepoint: Every 15 minutes. Method of measurement: Houpt scale.	—

Secondary

Measure	Time frame
SpO2. Timepoint: Every 15 minutes. Method of measurement: Pulse oximeter.;Heart rate. Timepoint: Every 15 minutes. Method of measurement: Pulse oximeter.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahid Beheshti University of Medical Sciences

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