Intranasal Dexmedetomidine Versus Intranasal Midazolam as a Premedication in Pediatrics Undergoing Upper GI Endoscopy
NCT ID: NCT06181682
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
70 participants
INTERVENTIONAL
2024-01-31
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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dexmedetomidine group
patients will receive intranasal dexmedetomidine (1 microgram/kg) -Intranasal dexmedetomidine will be prepared from the 100 mcg/ml parenteral preparation in a 1-ml syringe, and 0.9% saline will be added to make a final volume of 1 ml- (0.5 ml will be administrated in each nostril) before starting the anesthesia with monitoring of sedation level and oxygen saturation.
Dexmedetomidine
Intranasal Dexmedetomidine
midazolam group
patients will receive intranasal midazolam (0.2 mg/kg) up to 5 mg - Intranasal midazolam will be prepared from a 5 mg/ml parenteral preparation, and 0.9% saline will be added to make a final volume of one ml in a 1-ml syringe- (0.5 ml will be administrated in each nostril) before starting the anesthesia with monitoring of sedation level and oxygen saturation.
Midazolam
Intranasal midazolam
Interventions
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Dexmedetomidine
Intranasal Dexmedetomidine
Midazolam
Intranasal midazolam
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American scocity of anaesthesiology (ASA) I - II children.
* Expected duration of the procedure is less than 50 minutes.
Exclusion Criteria
* Behavioral, mental or developmental abnormality (example: mental retardation, Attention Deficit Hyperactivity Disorder "ADHD", Autism, Down syndrome).
* Regular intake of either brain stimulant or depressive drugs (example: Methylphenidate, amphetamine-dextroamphetamine and diazepam respectively).
* Parent's refusal.
* Emergency case.
* Allergy to any of the used drugs
2 Years
6 Years
ALL
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Marwa Mostafa Hasan Salem
Principal Investigator
Central Contacts
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Other Identifiers
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ASU MS
Identifier Type: -
Identifier Source: org_study_id