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

Phase 1

Completed

• Conditions: Oncological Children
• Interventions: Drug: nebulized ketamine; Drug: nebulized Dexmedetomidine; Drug: nebulized midazolam

• Registration Number: NCT02935959
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-18
• Primary Completion: 2017-09
• Study Completion: 2017-10
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-10
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nebulized ketamine	nebulized ketamine	patients will be premedicated with nebulized ketamine solution (2 mg/kg)
nebulized dexmedetomidine	nebulized Dexmedetomidine	patients will be premedicated with nebulized dexmedetomidine solution (2 μg/kg)
nebulized midazolam	nebulized midazolam	patients will be premedicated with midazolam (0.2 mg/kg) nebulized solution

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt