sedative effect of intranasal ketamine/midazolam on 3-6 year old children behavior in pediatric dentistry

Intranasal midazolam/ketamine sedation of 3-6 year old uncooperative dental patients

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT201305101882N3

Enrollment

Registered

2014-06-26

Start date

2012-03-19

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Anxiety. F13

Interventions

Intervention 1: First visit Case group: Intranasal 10mg/kg ketamine+ 0.5mg/kg midazolam Control group: Oral 10mg/kg ketamine+ 0.5mg/kg midazolam. Intervention 2: Second visit Control group: Intran

Treatment - Drugs

First visit Case group: Intranasal 10mg/kg ketamine+ 0.5mg/kg midazolam Control group: Oral 10mg/kg ketamine+ 0.5mg/kg midazolam

Second visit Control group: Intranasal 10mg/kg ketamine+ 0.5mg/kg midazolam Case group: Oral 10mg/kg ketamine+ 0.5mg/kg midazolam

Eligibility

Sex/Gender

All

Age

3 Years to 6 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1-Frankle 1,2 uncooperative child 2-ASA 1,2 healthy child 3-Needs to at least 2 treatment session Exclusion criteria: 1- Nasal obturation 2- Respratory infection 3-Tonsile hypertrophy 4-Macroglosia

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sleeping. Timepoint: After effect of drug, 15 and 30 minutes. Method of measurement: Observation and Houpt Scale.;Crying. Timepoint: After effect of drug, 15 and 30 minutes. Method of measurement: Observation and Houpt Scale.;Movement. Timepoint: After effect of drug, 15 and 30 minutes. Method of measurement: Observation and Houpt Scale.;Overall Behavior. Timepoint: After effect of drug, 15 and 30 minutes. Method of measurement: Observation and Houpt Scale.	—

Measure

Time frame

Sleeping. Timepoint: After effect of drug, 15 and 30 minutes. Method of measurement: Observation and Houpt Scale.;Crying. Timepoint: After effect of drug, 15 and 30 minutes. Method of measurement: Observation and Houpt Scale.;Movement. Timepoint: After effect of drug, 15 and 30 minutes. Method of measurement: Observation and Houpt Scale.;Overall Behavior. Timepoint: After effect of drug, 15 and 30 minutes. Method of measurement: Observation and Houpt Scale.

—

Secondary

Measure	Time frame
Heart Rate. Timepoint: Befor treatment, after effect of drug, 15and 30 minutes. Method of measurement: Pulse oxymeter.;Spo2. Timepoint: Befor treatment, after effect of drug, 15and 30 minutes. Method of measurement: Pulse oxymeter.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.AA Soleymani

Research Dental Center

asoleimani@gmail.com+98 21 2241 3897

Outcome results

None listed

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