Sedative effect of ketamine / propofol and ketamine / midazolam on non-cooperating children in pediatric dentistry

Comparison of the IV sedation effect of ketamine/propofol and ketamine/ midazolam in dental treatments of 2-6 years old uncooperative children

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090506001882N10

Enrollment

Registered

2021-03-08

Start date

2021-04-09

Completion date

Unknown

Last updated

2021-04-26

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 2mg/kg Ketamine(50mg/cc, Rotexmedica Co., Germany)+2mg/kg Propofol(10mg/cc Fresenius C.,Austria). Intervention 2: Intervention group: Intra

Eligibility

Sex/Gender

All

Age

2 Years to 6 Years

Inclusion criteria

Inclusion criteria: Be in the negative group be 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 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