Endoscopy Clinical Trial
Official title:
Clinical Trial of Oral Midazolam in Pediatric Endoscopy
Verified date | April 2008 |
Source | Tabriz University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ethics Committee |
Study type | Interventional |
The objective of our study was to compare the safety and efficacy of oral midazolam during pediatric endoscopy.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 17 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Liver &Gastrointestinal Research center of tabriz medical university | Tabriz | East Azarbijan |
Lead Sponsor | Collaborator |
---|---|
Tabriz University |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | efficacy and safety of endoscopy in children with used midazolam | Yes | ||
Secondary | The level of sedation | Yes | ||
Secondary | patient complications, ease of performing the procedure, time of preparation, time for recovery | Yes |
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