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| Name | Class |
|---|---|
| SipNose | UNKNOWN |
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A Three-arm, Randomized Controlled Trial for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety: Intranasal Midazolam by SipNose versus MAD Versus oral administration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Midazolam by SipNose device | Experimental |
| |
| Intranasal Midazolam by MAD (Mucosal Atomization Device) | Active Comparator |
| |
| oral administration of midazolam | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sipnose device | Device | SipNose's intranasal drug delivery platform uses an innovative mechanism that is suposed to improves efficacy, patient compliance and safety |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anexiety level | measured by modified PREOPERATIVE ANXIETY SCALE (YALE) | within 60 minute |
| Sedation level | measured by RAMSAY SEDATION SCALE | within 60 minute |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Children's Medical Center of Israel | Petah Tikva | 49202 | Israel |
Because of commercial confidentially the study database will not become public within the first 3 years since the begining of the study
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| MAD (Mucosal Atomization Device) | Device | MAD (Mucosal Atomization Device) |
|
| midazolam | Drug | oral administration of midazolam |
|
| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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