NCT00636428

Clinical Trial of Oral Midazolam in Pediatric Endoscopy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Tabriz University · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endoscopy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2008-03-14
• Last updated: 2008-04-11

Locations

1 site across 1 country: Iran