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Oral Sedation in children

Comparing the sedative effect of oral Midazolam/Hydroxyzine vs Chloral hydrate/Hydroxizine in behavior control of 6-10 year old uncooperative children.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014010616106N1
Enrollment
60
Registered
2014-02-05
Start date
2010-10-11
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

Condition 1: Behavior Control at the Dental Clinics. Condition 2: Uncooperative behavior in dental clinic. Behavioural syndromes associated with physiological disturbances and physical factors

Interventions

Intervention 1: Chloral Hydrate (50 mg/kg) /Hydroxyzine (1 mg/kg) both suspension form were given to children of the case group (oral mode), 1/2 hour before treatment start along with full monitoring
Treatment - Drugs
Chloral Hydrate (50 mg/kg) /Hydroxyzine (1 mg/kg) both suspension form were given to children of the case group (oral mode), 1/2 hour before treatment start along with full monitoring the vital signs
Oral suspension of Midazolam(0.5 mg/kg) along side Hydroxyzine elexir (1mg/kg)was administered in Control session 30 minutes prior to the starting point of the dental treatment in one dose. All vital

Sponsors

Iran Center for Dental Research, Shahid Beheshti Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 10 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: cases with a behavioral score of 2 in Frankel scale system (Uncooperative); those with at least two similar dental needs; ages of 6-10 years old; able to attend two visits scheduled for dental treatments; able to keep 4 hours NPO prior to sedation. Exclusion criteria: clear from any medical condition (out of the ASA I & II); taking any sedative, narcotic or CNS depressant drug; those who have cold or other respiratory obstruction; those having fever of known or unknown origin; unable to observe 4 hours of NPO; unable to accept the drugs administered due to taste or volume.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Assessing the success rate in child management. Timepoint: Exactly after the operation ends. Method of measurement: Behavior Assessment indices.;Child cooperation for Dental treatment delivery. Timepoint: Immidiately after the treatment end. Method of measurement: Judged by independent pediatric dentist and the operator.

Secondary

MeasureTime frame
Potential side effects of the drugs. Timepoint: End of1st year of the study. Method of measurement: Questionnaire and behavioral scales.;Assessing the success rate in each group. Timepoint: Half way assessments of the collected data. Method of measurement: Employing behavioral rating scales available.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGhassem Ansari

Shahid Beheshti Medical University

drgansari@yahoo.com+98 21 2225 5958

Outcome results

None listed

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