Effectiveness of oral and injectable midazolam on children behavior in dentistry

Comparison of sedative effect of syrup of midazolam and injectable midazolam (as oral) on behavior of 3-6 years old uncooperative children in dentistry

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201406171882N5

Enrollment

Registered

2016-02-25

Start date

2013-07-06

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

Fear and anxiety. Organic, including symptomatic, mental disorders

Interventions

Intervention 1: 0.5 mg/kg Syrup of Midazolam(Amsed, England) +1 mg/kg Hydroyzine(Abureyhan, Iran). Waiting time for sedation 20 to 30 minute. Treatment time: 30 minute. Intervention 2: 0.5 mg/kg inje

Treatment - Drugs

0.5 mg/kg Syrup of Midazolam(Amsed, England) +1 mg/kg Hydroyzine(Abureyhan, Iran). Waiting time for sedation 20 to 30 minute. Treatment time: 30 minute

0.5 mg/kg injectable Midazolam as oral (Darupakhsh, Iran) + 1 mg/kg Hydroxyzine(Abureyhan, Iran). Waiting time: 20-30 minutes. Treatment time:30 minutes

Eligibility

Sex/Gender

All

Age

3 Years to 6 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Healthy 3-6 years old children as ASA1 classification? Uncooperative negative and definitely negative according to Frankle scale? Having at least two sessions of dental treatment Exclusion criteria: Cold and allergy? Tonsils hypertrophy more than 50%; Severe obesity

Exclusion criteria

Exclusion criteria:

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 ContactDr. Sarira Zomorodian

Dental Research Center, Shahid Beheshti Dental School

sarira_zomorodian@yahoo.com+98 21 2240 3080

Outcome results

None listed

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