The Sedation Effect of Anxiolytic drugs on uncooperative children's behavior during dental treatment

Conscious sedation effect of oral chloral hydrate-hydroxyzine versus midazolam-hydroxyzine in uncooperative 2-6 year old children undergoing dental treatment

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT138903071882N2

Enrollment

Registered

2011-05-02

Start date

2010-04-30

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: Midazolm 0.5mg/kg + Hydroxyzine 1mg/kg Expected time for sedation: 20-30 minutes Treatment time: 30 minutes. Intervention 2: Chloral Hydrate 50mg/kg + hydroxyzine 1mg/kg Expected time

Treatment - Drugs

Midazolm 0.5mg/kg + Hydroxyzine 1mg/kg Expected time for sedation: 20-30 minutes Treatment time: 30 minutes

Chloral Hydrate 50mg/kg + hydroxyzine 1mg/kg Expected time for sedation: 30-45 minutes Treatment time: 30 minutes

Eligibility

Sex/Gender

All

Age

2 Years to 6 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Healthy child (ASA I-II), uncooperative child, at least 2sessions similar treatment Exclusion criteria: severe obesity, Tonsilar hypertrophy (more than 50%), presence of common cold

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Conscious Sedation. Timepoint: Every 15 minutes. Method of measurement: Houpt criteria.	—

Secondary

Measure	Time frame
Arterial blood saturation. Timepoint: Every 15 minutes. Method of measurement: Pulse Oxymeter.;Pulse Rate. Timepoint: Every 15 minutes. Method of measurement: Pulse Oxymeter.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Vahid Golpayegani M

Shahid Beheshti Dental School

mvahidg@yahoo.com+98 21 2240 3010

Outcome results

None listed

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