Trial | NCT00636428  Report issue

Official Title

Clinical Trial of Oral Midazolam in Pediatric Endoscopy

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    midazolam ...

  • Study Participants

    50
The 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.
Study Started
Mar 31
2007
Primary Completion
Mar 31
2008
Study Completion
Mar 31
2008
Last Update
Apr 11
2008
Estimate

Drug Midazolam

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.

1 Active Comparator

Oral midazolam

2 Active Comparator

IV Midazolam

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
No Results Posted