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

Not Applicable

Completed

• Conditions: Procedural Sedation and Analgesia During Bone Marrow Aspiration and Biopsy
• Interventions: Drug: Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine; Drug: midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine

• Registration Number: NCT03647579
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-24
• Study First Posted: 2018-08-27
• Study Start: 2018-08-30
• Primary Completion: 2018-12-15
• Study Completion: 2019-04-20
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine plus ketamine	Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine	-
midazolam plus ketamine	midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine	-

Primary Outcome Measures

Name	Time	Method
efficacy of drug mixture on procedural sedation and analgesia: Ramsay sedation score	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.

Trial Locations

Locations (1)

South Egypt Cancer Institute, Assiut University; 🇪🇬 Assiut, Egypt