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Dexmedetomidine Versus Midazolam Added to Ketamine in Pediatric Patients Undergoing Bone Marrow Aspiration and Biopsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03647579
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed H Othman, Assiut University

Tracking Information
First Submitted Date  ICMJE August 23, 2018
First Posted Date  ICMJE August 27, 2018
Last Update Posted Date October 3, 2019
Actual Study Start Date  ICMJE August 30, 2018
Actual Primary Completion Date December 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2018)
efficacy of drug mixture on procedural sedation and analgesia: Ramsay sedation score [ Time Frame: within the time of the procedure of bone marrow aspirate and biopsy ]
to assess efficacy of procedural sedation and analgesia with drug mixture;using Ramsay sedation score. Ramsay score
  1. Nervous, agitated, and/or restless.
  2. Cooperative, orientated, quite patient.
  3. Only obeying orders.
  4. Sleeping, hitting the glabella, and responding to high voice suddenly
  5. Sleeping, hitting the glabella, and responding to high voice slowly
  6. No response to any of these stimulations Dexemeditomidine and midazolam will be started 2 minutes before procedure through a peripheral venous cannula and continued as maintainance, then ketamine will be administered over 10-20 s aiming to achieve a sedation level of 3 or 4 on Ramsay scale to start the procedure.
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
efficacy of drug mixture on procedural sedation and analgesia: Ramsay sedation score [ Time Frame: within the time of the procedure of bone marrow aspirate and biopsy ]
to assess efficacy of procedural sedation and analgesia with drug mixture;using Ramsay sedation score.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine Versus Midazolam Added to Ketamine in Pediatric Patients Undergoing Bone Marrow Aspiration and Biopsy
Official Title  ICMJE Effect of Single Dose Dexmedetomidine Versus Midazolam on Emergence Agitation and Recovery Profile When Added to Ketamine for Procedural Sedation and Analgesia in Pediatric Patients Undergoing Bone Marrow Aspiration and Biopsy
Brief Summary

Group I :The patients will receive midazolam intravenously (i.v.) in a dose of 0.05 mg/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine (iv).

Group II : The patients will receive Dexmedetomidine intravenously (i.v.) in a dose of 2mic/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine (iv).

The objective of this study to evaluate the clinical effects, adverse effects and recovery time of two different sedative agents (midazolam and Dexmedetomidine) combined with ketamine during conscious sedation for child patient with haematological cancer undergoing BMA &biopsy.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Procedural Sedation and Analgesia During Bone Marrow Aspiration and Biopsy
Intervention  ICMJE
  • Drug: midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine
    midazolam intravenously (i.v.) in a dose of 0.05 mg/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine
  • Drug: Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine
    Dexmedetomidine intravenously (i.v.) in a dose of 2mic/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine
Study Arms  ICMJE
  • Active Comparator: midazolam plus ketamine
    Intervention: Drug: midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine
  • Active Comparator: dexmedetomidine plus ketamine
    Intervention: Drug: Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine
Publications * Not Provided

*   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: August 24, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 20, 2019
Actual Primary Completion Date December 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All consecutive children with acute lymphoblastic leukemia undergoing bone marrow aspiration and biopsy.

Exclusion criteria:

  • previous sensitization or anaphylactic reaction to Dexmedetomidine, ketamine,and midazolam;
  • evidence of head injury,
  • raised intracranial or intraocular tension;
  • use of drugs known to interact with either study agent;
  • an American Society of Anesthesiologists (ASA) physical status score greater than 2.
  • Also Patients with cardiovascular, respiratory, hepatic diseases and epilepsy will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 12 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 NCT03647579
Other Study ID Numbers  ICMJE 17100208
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ahmed H Othman, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date October 2019

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