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

NCT ID: NCT02935959

Last Updated: 2018-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-10-31

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.

Conditions

Oncological Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

nebulized ketamine

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

Group Type: ACTIVE_COMPARATOR

nebulized ketamine

Intervention Type: 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.

nebulized dexmedetomidine

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

Group Type: ACTIVE_COMPARATOR

nebulized Dexmedetomidine

Intervention Type: DRUG

nebulized midazolam

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

Group Type: ACTIVE_COMPARATOR

nebulized midazolam

Intervention Type: DRUG

Interventions

nebulized ketamine

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.

Intervention Type: DRUG

nebulized Dexmedetomidine

Intervention Type: DRUG

nebulized midazolam

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Shereen Mamdouh

lecturer of anesthesia,ICU and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

fatma a elsherif, lecturer

Role: STUDY_CHAIR

South Egypt Cancer Institute

Locations

Assiut University

Asyut, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 30032884 (View on PubMed)

Other Identifiers

349

Identifier Type: -

Identifier Source: org_study_id