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

Ketamine

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.

Intervention / Treatment

  • midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine (DRUG)
    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
  • Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine (DRUG)
    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

Condition or Disease

  • Procedural Sedation and Analgesia During Bone Marrow Aspiration and Biopsy

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 3 Years to 12 Years
    Enrollment: 100 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Care Provider

    Clinical Trial Dates

    Start date: Aug 30, 2018 ACTUAL
    Primary Completion: Dec 15, 2018 ACTUAL
    Completion Date: Apr 20, 2019 ACTUAL
    Study First Posted: Aug 27, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 01, 2019

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    Location

    Asyut, Egypt

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 3
    Maximum Age: 12
    Age Groups: Child
    Healthy Volunteers: Yes

    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.

    Primary Outcomes

    • 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.

    More Details

    NCT Number: NCT03647579
    Other IDs: 17100208
    Study URL: https://clinicaltrials.gov/study/NCT03647579
    Last updated: Sep 29, 2023