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

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

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.

Study Overview

• Status: Completed
• Conditions: Procedural Sedation and Analgesia During Bone Marrow Aspiration and Biopsy
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 171516
    • South Egypt Cancer Institute, Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy of drug mixture on procedural sedation and analgesia: Ramsay sedation score	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.	within the time of the procedure of bone marrow aspirate and biopsy

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2018
• Primary Completion (Actual): December 15, 2018
• Study Completion (Actual): April 20, 2019

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Ketamine; Midazolam; Dexmedetomidine
• Other Study ID Numbers: 17100208

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No