Official Title
Clinical Trial of Oral Midazolam in Pediatric Endoscopy
Phase
Phase 4Lead Sponsor
University of TabrizStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
EndoscopyIntervention/Treatment
midazolam ...Study Participants
50The objective of our study was to compare the safety and efficacy of oral midazolam during pediatric endoscopy.
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.
oral midazolam, was prepared into a final solution (2.5 mg/mL) from injectable midazolam hydrochloride and a orange flavored syrup. For preparation, midazolam injection (5 mg/mL) was diluted 1:1 with the flavored syrup.
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