- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00636428
Clinical Trial of Oral Midazolam in Pediatric Endoscopy
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
East Azarbijan
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Tabriz, East Azarbijan, Iran, Islamic Republic of, 51664
- Liver &Gastrointestinal Research center of tabriz medical university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Oral 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: 2
IV 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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efficacy and safety of endoscopy in children with used midazolam
|
Secondary Outcome Measures
Outcome Measure |
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The level of sedation
|
patient complications, ease of performing the procedure, time of preparation, time for recovery
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: mandana Rafeey, Dr, Liver &Gastrointestinal Research center of tabriz medical university
- Study Chair: Mandana Rafeey, Dr, tabriz medical university
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Midazolam
Other Study ID Numbers
- 85-24
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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