Premedication With Nebulized Ketamine,Dexmedetomidine Versus Midazolam in Oncologic Preschool Children
Premedication With Different Nebulized Ketamine,Dexmedetomidine Versus Midazolam in Oncologic Preschool Children
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 12, 2016
CompletedFirst Posted
Study publicly available on registry
October 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedJanuary 12, 2018
January 1, 2018
11 months
October 12, 2016
January 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
parental separation
30 min after sedation
Emergecy agitation
30 min after induction
Study Arms (3)
nebulized ketamine
ACTIVE COMPARATORpatients will be premedicated with nebulized ketamine solution (2 mg/kg)
nebulized dexmedetomidine
ACTIVE COMPARATORpatients will be premedicated with nebulized dexmedetomidine solution (2 μg/kg)
nebulized midazolam
ACTIVE COMPARATORpatients will be premedicated with midazolam (0.2 mg/kg) nebulized solution
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.
Eligibility Criteria
You may qualify if:
- physical status I and II, scheduled for bone marrow aspirate and biopsy
You may not qualify if:
- known allergy to the studied drugs,
- organ dysfunction,
- cardiac dysrrhythmia and/or congenital heart disease,
- psychotropic medication use and mental retardation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University
Asyut, 171516, Egypt
Related Publications (1)
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.
PMID: 30032884DERIVED
Study Officials
- STUDY CHAIR
fatma a elsherif, lecturer
South Egypt Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of anesthesia,ICU and pain management
Study Record Dates
First Submitted
October 12, 2016
First Posted
October 18, 2016
Study Start
October 1, 2016
Primary Completion
September 1, 2017
Study Completion
October 1, 2017
Last Updated
January 12, 2018
Record last verified: 2018-01