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compare the effectiveness of intranasal dexmedetomidine and midazolam as a premedication in sedation of preschool children in GI endoscopy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine group | Active Comparator | 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. |
|
| midazolam group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Intranasal Dexmedetomidine |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| marwa Salem, MD | Contact | 1003591259 | 020 | marwamostafa@med.asu.edu.eg |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Midazolam | Drug | Intranasal midazolam |
|
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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 |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |