Oncological Children
Conditions
Brief summary
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
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.
Interventions
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.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the degree of sedation when the child was first seen in the OR | 30 minutes after sedation | measure the degree of sedation using using a 5 point sedation scale. Sedation level: Agitated =1, alert= 2, calm= 3, drowsy = 4, asleep=5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| parental separation | 30 min after sedation | The parental separation anxiety scale (PSAS) |
| Emergecy agitation | 30 min after induction | 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. |
Countries
Egypt
Outcome results
None listed