Evaluation of the combined effect of nasal midazolam/ketamine on sedation of 3-6 years non-cooperative pediatric dentistry

Title Comparison of Nasal Midazolam and Ketamine Effects in Different Doses on Relaxation of Non-Cooperative pediatric Dental patient 3-6 Years Old

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090506001882N9

Enrollment

Registered

2020-10-10

Start date

2020-03-10

Completion date

Unknown

Last updated

2020-11-09

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: The combination of 0.4 mg/kg midazolam (5 mg/cc , Darupakhsh Co., Iran) + 4 mg/kg ketamine (50 mg/ccThe combination of 4 mg / kg midazolam (5 mg/cc, Darupakhsh Co., Iran) + 4 mg/kg ket

Eligibility

Sex/Gender

All

Age

3 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 3 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 oxymeter.	—

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