Effect of Midazolam and Hydroxyzine premedication on reduction of side effects of Ketamine sedatio
Phase 2
- Conditions
- Anxiety.Organic anxiety disorder
- Registration Number
- IRCT201602291882N8
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
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
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.