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

Assiut University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Oncological Children

Treatments: Drug: nebulized midazolam; Drug: nebulized Dexmedetomidine; Drug: nebulized ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02935959

349

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

nebulized ketamine

Active Comparator group

Description:

patients will be premedicated with nebulized ketamine solution (2 mg/kg)

Treatment:

Drug: nebulized ketamine

nebulized dexmedetomidine

Active Comparator group

Description:

patients will be premedicated with nebulized dexmedetomidine solution (2 μg/kg)

Treatment:

Drug: nebulized Dexmedetomidine

nebulized midazolam

Active Comparator group

Description:

patients will be premedicated with midazolam (0.2 mg/kg) nebulized solution

Treatment:

Drug: nebulized midazolam