Clinical Trial of Oral Midazolam in Pediatric Endoscopy - Full Text View

Sponsor:	Tabriz University
Information provided by:	Tabriz University
ClinicalTrials.gov Identifier:	NCT00636428

Purpose

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

Condition	Intervention	Phase
Endoscopy	Drug: Midazolam	Phase IV

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Trial of Oral Midazolam in Pediatric Endoscopy

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy

Drug Information available for: Midazolam Midazolam maleate Midazolam hydrochloride

U.S. FDA Resources

Further study details as provided by Tabriz University:

Primary Outcome Measures:

efficacy and safety of endoscopy in children with used midazolam [ Time Frame: no ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The level of sedation [ Time Frame: no ] [ Designated as safety issue: Yes ]
patient complications, ease of performing the procedure, time of preparation, time for recovery [ Time Frame: no ] [ Designated as safety issue: Yes ]

Enrollment:	50
Study Start Date:	March 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Oral midazolam	Drug: 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.
2: Active Comparator IV Midazolam	Drug: 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.

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.

Eligibility

Ages Eligible for Study:	3 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636428

Locations

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

Sponsors and Collaborators

Tabriz University

Investigators

Study Chair:	mandana Rafeey, Dr	liver &Gastrointestinal Research center of tabriz medical university
Study Chair:	Mandana Rafeey, Dr	tabriz medical university

More Information

No publications provided

Responsible Party:	Tabriz University of Medical Sciences ( Alireza Javadzadeh )
Study ID Numbers:	85-24
Study First Received:	March 7, 2008
Last Updated:	April 8, 2008
ClinicalTrials.gov Identifier:	NCT00636428 History of Changes
Health Authority:	Iran: Ethics Committee

Keywords provided by Tabriz University:

endoscopy
Midazolam
pediatric
sedation
comfort

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Central Nervous System Depressants

Midazolam
Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010