Premedication With Nebulized Ketamine,Dexmedetomidine Versus Midazolam in Oncologic Preschool Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Premedication With Different Nebulized Ketamine,Dexmedetomidine Versus Midazolam in Oncologic Preschool Children

Conditions
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Oncological Children

Intervention / Treatment
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* Drug: nebulized ketamine
* Drug: nebulized Dexmedetomidine
* Drug: nebulized midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: physical status I and II, scheduled for bone marrow aspirate and biopsy Exclusion Criteria: known allergy to the studied drugs, organ dysfunction, cardiac dysrrhythmia and/or congenital heart disease, psychotropic medication use and mental retardation

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nebulized ketamine<br>patients will be premedicated with nebulized ketamine solution (2 mg/kg) | Drug: nebulized ketamine<br>* 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.<br>|
| Active Comparator: nebulized dexmedetomidine<br>patients will be premedicated with nebulized dexmedetomidine solution (2 μg/kg) | Drug: nebulized Dexmedetomidine<br> <br> |
| Active Comparator: nebulized midazolam<br>patients will be premedicated with midazolam (0.2 mg/kg) nebulized solution | Drug: nebulized midazolam<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 30 min after induction |