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Effect of Midazolam and Hydroxyzine premedication on reduction of side effects of Ketamine sedation

Comparison of the Effects of Midazolam and Hydroxyzine premedication on side effects of Ketamine Intravenous Sedation in Pediatric Dentistry

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201602291882N8
Enrollment
20
Registered
2016-10-24
Start date
2014-10-02
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. Organic anxiety disorder

Interventions

Intervention 1: Syrup of Hydroxyzine( Kharazmi Phrmaceutic Co., Iran) 1mg/kg as oral and premedication. Intervention 2: Midazolam syrup(Dales Pharmaceutic, England) 0.5 mg/kg+ Atropine(Caspian Pharma
Treatment - Drugs
Syrup of Hydroxyzine( Kharazmi Phrmaceutic Co., Iran) 1mg/kg as oral and premedication.
Midazolam syrup(Dales Pharmaceutic, England) 0.5 mg/kg+ Atropine(Caspian Pharmaceutic,Iran) 0.25 mg/kg, as oral and premedication.

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Healthy 2-6 years old children? Uncooperative negative and definitely ranked as Frankel scale? having at least two sessions dental treatment Exclusion criteria: Cold and allergy?Tonsils hypertrophy more than 50%? severe obesity

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Drowsiness. Timepoint: 1 hour, 2 hours after sedation and 6 hours after discharge. Method of measurement: Parents observation and report.;Nausea. Timepoint: 1 hour, 2 hours after sedation and 6 hours after discharge. Method of measurement: Parents observation and report.;Dizziness. Timepoint: 1 hour, 2 hours after sedation and 6 hours after discharge. Method of measurement: Parents observation and report.;Vomit. Timepoint: 1 hour, 2 hours after sedation and 6 hours after discharge. Method of measurement: Parents observation and report.

Secondary

MeasureTime frame
Conscious sedation. Timepoint: Every 15 minutes. Method of measurement: Houpt scale.;SpO2. Timepoint: Every 15 minutes. Method of measurement: pulse oxymeter.;Heart Rate. Timepoint: Every 15 minutes. Method of measurement: pulse oxymeter.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Anahita Bozorgmanesh

Dental Research Center, Shahid Beheshti Dental School

ab516983@yahoo,com+98 21 2240 3075

Outcome results

None listed

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