NCT00636428
Completed
Phase 4
Clinical Trial of Oral Midazolam in Pediatric Endoscopy
Tabriz University1 site in 1 country50 target enrollmentMarch 2007
Overview
- Phase
- Phase 4
- Intervention
- Midazolam
- Conditions
- Endoscopy
- Sponsor
- Tabriz University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- efficacy and safety of endoscopy in children with used midazolam
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
The objective of our study was to compare the safety and efficacy of oral midazolam during pediatric endoscopy.
Detailed Description
Although gastrointestinal endoscopy is widely accepted as fundamental to the diagnosis and treatment of digestive disorders in children, considerable controversy and practice differences persist with respect to the methods and agents used to achieve optimal endoscopic sedation. Comparison:oral midazolam vs midazolam IV in sedation and comfort scale of pediatric endoscopy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All of patients scheduled for endoscopy participated in the study.
Exclusion Criteria
- •Exclusion criteria were as follows:
- •Children younger than 3 years;
- •Children with significant neurological disability;
- •Children with a history of allergies to benzodiazepines, or to their components;
- •Children with metabolic, cardiac or renal disease; children with previous - Complications to IV sedation;
- •Children with respiratory distress
- •Age under 1 mo and bigger than 17y
- •History of erythromycin used in 4 week ago
Arms & Interventions
1
Oral midazolam
Intervention: Midazolam
2
IV Midazolam
Intervention: Midazolam
Outcomes
Primary Outcomes
efficacy and safety of endoscopy in children with used midazolam
Secondary Outcomes
- The level of sedation
- patient complications, ease of performing the procedure, time of preparation, time for recovery
Study Sites (1)
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