Clinical Trial of Oral Midazolam in Pediatric Endoscopy

Phase 4

Completed

• Conditions: Endoscopy
• Interventions: Drug: Midazolam

• Registration Number: NCT00636428
• Lead Sponsor: Tabriz University

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.

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2008-03-07
• Study First Submitted QC: 2008-03-13
• Study First Posted: 2008-03-14
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-08
• Last Update Posted: 2008-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All of patients scheduled for endoscopy participated in the study.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Midazolam	Oral midazolam
2	Midazolam	IV Midazolam

Primary Outcome Measures

Name	Time	Method
efficacy and safety of endoscopy in children with used midazolam

Secondary Outcome Measures

Name	Time	Method
The level of sedation
patient complications, ease of performing the procedure, time of preparation, time for recovery

Trial Locations

Locations (1)

Liver &Gastrointestinal Research center of tabriz medical university; 🇮🇷 Tabriz, East Azarbijan, Iran, Islamic Republic of