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Evaluate the efficacy of nebulized dexmedetomidine, nebulized ketamine, and nebulized midazolam a premedication prior to general anesthesia (GA) in oncologic preschool children undergo bone marrow aspirate and biopsy.
The preoperative period can be a traumatic time for young children undergoing surgery. Pediatric anesthesiologists strive to minimize distress for children in the operating room (OR) environment and to provide a smooth induction of anesthesia. Preoperative anxiety stimulates the sympathetic, parasympathetic, and endocrine systems, leading to an increase in heart rate (HR), blood pressure, and cardiac excitability. Various drugs have been advocated as premedication to allay anxiety and facilitate the smooth separation of children from parents. The ideal premedicant in children should be readily acceptable and should have a rapid and reliable onset with minimal side effects. Dexmedetomidine is a tasteless, colorless, and odorless drug that acts as a selective α-2 adrenergic agonist with both sedative and analgesic effects via actions in the central nervous system. Ketamine is an N-methyl-d-aspartate receptor antagonist that produces a state of sedation, anesthesia, immobility, analgesia, amnesia, and dissociation from the environment. Midazolam is a water-soluble benzodiazepine known to have a rapid onset and short duration of action, as well as properties of amnesia and anxiolysis. Administered intranasally, midazolam is an effective option for conscious sedation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nebulized ketamine | Active Comparator | patients will be premedicated with nebulized ketamine solution (2 mg/kg) |
|
| nebulized dexmedetomidine | Active Comparator | patients will be premedicated with nebulized dexmedetomidine solution (2 μg/kg) |
|
| nebulized midazolam | Active Comparator | patients will be premedicated with midazolam (0.2 mg/kg) nebulized solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nebulized ketamine | Drug | Drugs will be prepared in 3 mL of saline 0.9% before administration by a standard hospital jet nebulizer via a mouthpiece, with a continuous flow of 100% oxygen at 6 L/min for 10 to 15 minutes (30 minutes before GA). Treatment will be stopped when the nebulizer began to sputter. |
| Measure | Description | Time Frame |
|---|---|---|
| the degree of sedation when the child was first seen in the OR | measure the degree of sedation using using a 5 point sedation scale. Sedation level: Agitated =1, alert= 2, calm= 3, drowsy = 4, asleep=5. | 30 minutes after sedation |
| Measure | Description | Time Frame |
|---|---|---|
| parental separation | The parental separation anxiety scale (PSAS) | 30 min after sedation |
| Emergecy agitation | Emergence agitation will be assessed according to a 3-point scale: 1 = calm; 2 = restless but calms to verbal instructions; and 3 = combative and disoriented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| fatma a elsherif, lecturer | South Egypt Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University | Asyut | 171516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30032884 | Derived | Abdel-Ghaffar HS, Kamal SM, El Sherif FA, Mohamed SA. Comparison of nebulised dexmedetomidine, ketamine, or midazolam for premedication in preschool children undergoing bone marrow biopsy. Br J Anaesth. 2018 Aug;121(2):445-452. doi: 10.1016/j.bja.2018.03.039. Epub 2018 Jun 22. |
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|
| nebulized Dexmedetomidine | Drug |
|
| nebulized midazolam | Drug |
|
| 30 min after induction |