Intranasal Dexmedetomidine Versus Intranasal Midazolam as a Premedication in Pediatrics Undergoing Upper GI Endoscopy

Study Overview
=================
Brief Summary
-----------------
compare the effectiveness of intranasal dexmedetomidine and midazolam as a premedication in sedation of preschool children in GI endoscopy

Official Title
-----------------
Intranasal Dexmedetomidine Versus Intranasal Midazolam as a Premedication in Pediatrics Undergoing Upper GI Endoscopy

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children of preschool age (2-6 years old). American scocity of anaesthesiology (ASA) I - II children. Expected duration of the procedure is less than 50 minutes. Exclusion Criteria: Cardiac arrhythmia, congenital heart disease, or hemodynamic or respiratory instability; children at risk for airway obstruction. 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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexmedetomidine group<br>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. | Drug: Dexmedetomidine<br>* Intranasal Dexmedetomidine<br>* Other names: Precedex;|
| Active Comparator: midazolam group<br>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. | Drug: Midazolam<br>* Intranasal midazolam<br>* Other names: Dormicum;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation status at separation from the parent | Parental separation anxiety scale (PSAS) ,A score of 1-2 was considered satisfactory separation and a score of 3-4 was considered unsatisfactory separation. | within 30 minutes after drugs administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of sedation | Onset of sedation will be recorded according to Modified RAMSAY Sedation Scale when the score reaches 3 points, patient is then ready to be transferred. | within 30 minutes after drugs administration | 
| awakening time | recovery time (defined as return of consciousness, recovery of protective air way reflexes and resumption of motor activity) | within 15 minutes after end of anaesthesia | 
| post-operative emergence delirium and agitation. | (PAED) scale: Pediatric Anesthesia Emergence Delirium (PAED) scales. scale from 0 to 20. higher scores mean a worse outcome | within 30 minutes from recovery |