evaluation and comparison the effectiveness of oral melatonin and midazolam as premedication on sedation and post operative complications of candidate children for dental treatment under general anesthesia with contral group
Phase 2
- Conditions
- anxiety.Psychotropic drugs, not elsewhere classified
- Registration Number
- IRCT201602074224N36
- Lead Sponsor
- Vice chancellor for research- Esfahan university of medical sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 132
Inclusion Criteria
Inclusion criteria include:Children should be ASA1 or ASA2 (Systemic disease is confinder); Children cooperation should be in grade 1 or 2 of Frankl classification ; children should not use benzodiazepin, barbitorate or analgesics.(usage of these drugs can interfere with true effect od melatonin and midazolam); children should not have bodily or mentally disabilities; children should not have contraindication for anesthesia with propofol.6.children should not have history of convulsion
exclusion criteria include:lf complications was found during operation ; If oeration takes less than 30 minutes or more than 120 minutes ; If parents are not cooperative and consont is not assigned
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Agitation. Timepoint: 20 minutes. Method of measurement: agitation scale.
- Secondary Outcome Measures
Name Time Method ausea. Timepoint: 24 hours. Method of measurement: nausea scale.