Clinical Trial of Oral Midazolam in Pediatric Endoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-03-31

Brief Summary

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The objective of our study was to compare the safety and efficacy of oral midazolam during pediatric endoscopy.

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Detailed Description

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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

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Endoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Oral midazolam

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

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.

2

IV Midazolam

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No