Clinical Trial of Oral Midazolam in Pediatric Endoscopy

Condition(s) targeted: Endoscopy

Intervention: Midazolam (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Tabriz University

Official(s) and/or principal investigator(s):
mandana Rafeey, Dr, Study Chair, Affiliation: liver &Gastrointestinal Research center of tabriz medical university
Mandana Rafeey, Dr, Study Chair, Affiliation: tabriz medical university

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

Official title: Clinical Trial of Oral Midazolam in Pediatric Endoscopy

Study design: Supportive Care, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: efficacy and safety of endoscopy in children with used midazolam

Secondary outcome:

The level of sedation

patient complications, ease of performing the procedure, time of preparation, time for recovery

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.

Minimum age: 3 Years. Maximum age: 17 Years. Gender(s): Both.

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

Liver &Gastrointestinal Research center of tabriz medical university, tabriz, East Azarbijan 51664, Iran, Islamic Republic of

Starting date: March 2007
Ending date: March 2008
Last updated: April 8, 2008