Clinical Trial of Oral Midazolam in Pediatric Endoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00636428
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : April 11, 2008
Information provided by:
Tabriz University

March 7, 2008
March 14, 2008
April 11, 2008
March 2007
March 2008   (Final data collection date for primary outcome measure)
efficacy and safety of endoscopy in children with used midazolam
Same as current
Complete list of historical versions of study NCT00636428 on Archive Site
  • The level of sedation
  • patient complications, ease of performing the procedure, time of preparation, time for recovery
Same as current
Not Provided
Not Provided
Clinical Trial of Oral Midazolam in Pediatric Endoscopy
Clinical Trial of Oral Midazolam in Pediatric Endoscopy
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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
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.
  • Active Comparator: 1
    Oral midazolam
    Intervention: Drug: Midazolam
  • Active Comparator: 2
    IV Midazolam
    Intervention: Drug: Midazolam
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2008
March 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
3 Years to 17 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
Not Provided
Not Provided
Alireza Javadzadeh, Tabriz University of Medical Sciences
Tabriz University
Not Provided
Study Chair: mandana Rafeey, Dr liver &Gastrointestinal Research center of tabriz medical university
Study Chair: Mandana Rafeey, Dr tabriz medical university
Tabriz University
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP