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

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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

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.


Condition or disease Intervention/treatment Phase
Procedural Sedation and Analgesia During Bone Marrow Aspiration and Biopsy Drug: midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine Drug: Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 30, 2018
Actual Primary Completion Date : December 15, 2018
Actual Study Completion Date : April 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: midazolam plus ketamine 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

Active Comparator: dexmedetomidine plus 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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647579


Locations
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Egypt
South Egypt Cancer Institute, Assiut University
Assiut, Egypt, 171516
Sponsors and Collaborators
Assiut University

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Responsible Party: Ahmed H Othman, Assisstant professor of Anesthesia ICU and pain Relief, Assiut University
ClinicalTrials.gov Identifier: NCT03647579     History of Changes
Other Study ID Numbers: 17100208
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Midazolam
Dexmedetomidine
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents