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Fifty children undergoing heart catheterization without local anesthesia in the skin will be randomly divided into two groups.
Group DM (Dexmedetomidine + Midazolam) and Group KM (Ketamine + Midazolam)
Fifty children undergoing heart catheterization without local anesthesia in the skin will be randomly divided into two groups.
Group DM (Dexmedetomidine + Midazolam) will receive dexmedetomidine 1 µg/kg IV over 10 minutes and midazolam 0.1 mg/kg IV as a bolus concomitant with induction, followed by a continuous infusion of dexmedetomidine at 0.5 µg/kg/h and midazolam at 0.1 mg/kg/h for maintenance.
Group KM (Ketamine + Midazolam) will receive ketamine 1 mg/kg IV and midazolam 0.1 mg/kg IV as a bolus for induction, followed by a continuous infusion of ketamine at 1 mg/kg/h and midazolam at 0.1 mg/kg/h.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine-Midazolam | Active Comparator | Children will receive Dexmedetomidine + Midazolam |
|
| ketamine-Midazolam | Active Comparator | Children will receive ketamine + Midazolam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine and Midazolam | Drug | Children will receive Dexamedetomedine and Midazolam |
|
| Measure | Description | Time Frame |
|---|---|---|
| Emergence delirium | Incidence of emergence delirium assessed using the Pediatric Anesthesia Emergence Delirium PAED scale. The scale consists of five behavioral items, each rated on a 5-point scale from 0 to 4(Eye contact, Purposefulness, Awareness, Restlessness, Inconsolability),Total scores range from 0 to 20.A PAED score ≥10 will be considered a clinically significant ED. | 30 minutes post-anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Elhaddad, Ass.prof. | Contact | 01224042847 | drblacksmith@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Elhaddad, Ass.prof. | Faculty of medicins,Cairo university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasralainy Hospital | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ketamine and Midazolam | Drug | Children will receive Ketamine and Midazolam |
|
|
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |