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

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ClinicalTrials.gov Identifier: NCT02935959
Recruitment Status : Completed
First Posted : October 18, 2016
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Shereen Mamdouh, Assiut University

Tracking Information
First Submitted Date  ICMJE October 12, 2016
First Posted Date  ICMJE October 18, 2016
Last Update Posted Date January 12, 2018
Study Start Date  ICMJE October 2016
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2017)
the degree of sedation when the child was first seen in the OR [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
the degree of sedation when the child was first seen in the OR [ Time Frame: 30 minutes after sedation ]
measure the degree of sedation using using a 4 point sedation scale. Sedation level: Agitated =4, awake= 3, Drowsy= 2, Asleep = 1.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2017)
  • parental separation [ Time Frame: 30 min after sedation ]
    The parental separation anxiety scale (PSAS)
  • Emergecy agitation [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
  • heamodynamic changes [ Time Frame: 0 (preoperative), 5 min, 10 min,15 min,20 min, 30 min ]
    HR, mean arterial blood pressure [MAP], arterial oxygen saturation [Spo2%], and respiratory rate
  • Emergecy agitation [ Time Frame: 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Premedication With Nebulized Ketamine,Dexmedetomidine Versus Midazolam in Oncologic Preschool Children
Official Title  ICMJE Premedication With Different Nebulized Ketamine,Dexmedetomidine Versus Midazolam in Oncologic Preschool Children
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Oncological Children
Intervention  ICMJE
  • Drug: 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.
  • Drug: nebulized Dexmedetomidine
  • Drug: nebulized midazolam
Study Arms  ICMJE
  • Active Comparator: nebulized ketamine
    patients will be premedicated with nebulized ketamine solution (2 mg/kg)
    Intervention: Drug: nebulized ketamine
  • Active Comparator: nebulized dexmedetomidine
    patients will be premedicated with nebulized dexmedetomidine solution (2 μg/kg)
    Intervention: Drug: nebulized Dexmedetomidine
  • Active Comparator: nebulized midazolam
    patients will be premedicated with midazolam (0.2 mg/kg) nebulized solution
    Intervention: Drug: nebulized midazolam
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2018)
90
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2016)
60
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02935959
Other Study ID Numbers  ICMJE 349
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Shereen Mamdouh, Assiut University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Assiut University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: fatma a elsherif, lecturer South Egypt Cancer Institute
PRS Account Assiut University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP