Difference between the sedative effect of midazolam syrup 0.3 and 0.5 mg/kg in pediatric dentistry

Comparison of 0.3 and 0.5 mg/kg oral midazolam sedation in 3-6 years old uncooperative children undergoing dental treatment

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201406171882N6

Enrollment

Registered

2016-02-21

Start date

2013-07-01

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: 0.3 mg/kg Midazolam + 1 mg/kg Hydroxyzine. Intervention 2: 0.5 mg/kg Midazolam + 1mg/kg Hydroxyzine.

Treatment - Drugs

0.5 mg/kg Midazolam + 1mg/kg Hydroxyzine

0.3 mg/kg Midazolam + 1 mg/kg Hydroxyzine

Eligibility

Sex/Gender

All

Age

3 Years to 6 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: healthy 3-6 years old children? Uncooperative negative or definitely ranked as Frankel scale? have at least two sessions of the same therapy Exclusion criteria: Cold and allergy?Tonsils hypertrophy? 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 ooxymeter.;Heart Rate. Timepoint: Every 15 minutes. Method of measurement: Houpt scale.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Leila Hasanbeigy

Dental Research Center, Shahid Beheshti Dental School

leilahasanbeygi@yahoo.com+98 21 2240 3080

Outcome results

None listed

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