Clinical Trial of Oral Midazolam in Pediatric Endoscopy

This study has been completed.
Sponsor:
Information provided by:
Tabriz University
ClinicalTrials.gov Identifier:
NCT00636428
First received: March 7, 2008
Last updated: April 8, 2008
Last verified: April 2008

March 7, 2008
April 8, 2008
March 2007
March 2008   (final data collection date for primary outcome measure)
efficacy and safety of endoscopy in children with used midazolam [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00636428 on ClinicalTrials.gov Archive Site
  • The level of sedation [ Designated as safety issue: Yes ]
  • patient complications, ease of performing the procedure, time of preparation, time for recovery [ Designated as safety issue: Yes ]
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Endoscopy
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.
Other Name: Midazolam
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
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
Both
3 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00636428
85-24
Yes
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