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Clinical Trials/NCT00636428
NCT00636428
Completed
Phase 4

Clinical Trial of Oral Midazolam in Pediatric Endoscopy

Tabriz University1 site in 1 country50 target enrollmentMarch 2007
ConditionsEndoscopy
InterventionsMidazolam

Overview

Phase
Phase 4
Intervention
Midazolam
Conditions
Endoscopy
Sponsor
Tabriz University
Enrollment
50
Locations
1
Primary Endpoint
efficacy and safety of endoscopy in children with used midazolam
Status
Completed
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2007
End Date
March 2008
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Tabriz University

Eligibility 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

Arms & Interventions

1

Oral midazolam

Intervention: Midazolam

2

IV Midazolam

Intervention: Midazolam

Outcomes

Primary Outcomes

efficacy and safety of endoscopy in children with used midazolam

Secondary Outcomes

  • The level of sedation
  • patient complications, ease of performing the procedure, time of preparation, time for recovery

Study Sites (1)

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