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An increasing number of studies have reported the use of dexmedetomidine in clinical practice. However, few studies have reported on the intranasal use of dexmedetomidine in radiological procedures The aim of this work is to compare the efficacy and safety of intranasal dexmedetomidine and intranasal midazolam in pediatrics undergoing MRI.
This prospective randomized double-blind clinical trial will be carried out on 60 children undergoing elective MRI in Tanta University Hospitals.
Sixty children will be randomly allocated into two equal groups by computer-generated sequence through sealed opaque envelopes:
Group D: 30 children will be sedated with 2 μg/kg intranasal DEX. Group M: 30 children will be sedated with 0.3 mg/kg intranasal midazolam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine Group | Experimental | 30 children will be sedated with 2 μg/kg intranasal dexmedetomidine |
|
| Midazolam Group | Active Comparator | 30 children will be sedated with 0.3 mg/kg intranasal midazolam. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 30 children will be sedated with 2 μg/kg intranasal DEX. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of successful sedation | Successful sedation is defined as the time taken to achieve an MOAA/S score of 4 and is the time when the patients are calm and sedated and allow intravenous cannulation and MRI examination without crying or agitation. | One hour |
| Measure | Description | Time Frame |
|---|---|---|
| The onset time of sedation | The onset time of sedation is defined as the time from drug administration to successful sedation. | One hour |
| The occurrence of Adverse effects | The occurrences of adverse events will be recorded (e.g. bradycardia, a significant oxygen saturation decrease, severe arrhythmia or arrest). |
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Inclusion Criteria:
Aged from 2 to 8 years Both sexes ASA physical status I and II Elective MRI.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospitals | Tanta | ElGharbiaa | 31527 | Egypt |
The data will be provided with a reasonable request from authors
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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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Sixty children will be randomly allocated into two equal groups by computer generated sequence through sealed opaque envelopes:
Group D: 30 children will be sedated with 2 μg/kg intranasal DEX. Group M: 30 children will be sedated with 0.3 mg/kg intranasal midazolam.
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| Midazolam |
| Drug |
30 children will be sedated with 0.3 mg/kg intranasal midazolam. |
|
| One hour |
| The degree of operator satisfaction | MRI operator satisfaction before discharge using a 5- point score, with (0 = very dissatisfied, 1 = dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = very satisfied). | One hour |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |