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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Procedural Sedation and Analgesia During Bone Marrow Aspiration and Biopsy

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: midazolam plus ketamine<br> | Drug: midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine<br>* 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<br>|
| Active Comparator: dexmedetomidine plus ketamine<br> | Drug: Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine<br>* 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<br>|

What is the study measuring?
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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 |