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OpenTrials
Completed

NCT Number: NCT03647579

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

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.

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Key information

Conditions

Procedural Sedation and Analgesia During Bone Marrow Aspiration and Biopsy

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Egypt Cancer Institute, Assiut University

Asyut, 171516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  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

    • Nervous, agitated, and/or restless.
    • Cooperative, orientated, quite patient.
    • Only obeying orders.
    • Sleeping, hitting the glabella, and responding to high voice suddenly
    • Sleeping, hitting the glabella, and responding to high voice slowly
    • 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Aug 27, 2018
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.