Clinical Trial of Oral Midazolam in Pediatric Endoscopy

Tabriz University50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Endoscopy

Interventions

MidazolamDRUG

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.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Liver &Gastrointestinal Research center of tabriz medical university

Tabriz, East Azarbijan, Iran

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

Data from ClinicalTrials.gov

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