Effect of Dexmedomidine in pediatric anesthesia
Phase 3
- Conditions
- Opioid related disorders in pediatric intensive care unit.Opioid related disorders
- Registration Number
- IRCT20230520058235N1
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Age 1 year to 12 years
Admission to pediatric intensive care unit (PICU)
Under mechanical ventilation and sedation
Exclusion Criteria
Children receiving Barbiturates
Persistent bradycardia (less than 5th percentile of normal for age)
Hypotension (less than 5th percentile of normal age)
Cardiac arrhythmia
Involvement of the central nervous system (brain trauma, encephalitis, meningitis...)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determining and comparing the needed total Fentanyl dose in each group. Timepoint: From enrollment up to seven days. Method of measurement: Dose counting.;Determining and comparing the needed total Midazolam dose in each group. Timepoint: From enrollment up to seven days. Method of measurement: Dose counting.
- Secondary Outcome Measures
Name Time Method Determining the need for a second sedative drug in each group. Timepoint: From enrollment up to seven days. Method of measurement: Patient file.;Determining the need for the third sedative drug in each group. Timepoint: From enrollment up to seven days. Method of measurement: Patient file.;Determining the need for the muscle relaxant in each group. Timepoint: From enrollment up to seven days. Method of measurement: Patient file.