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

NCT ID: NCT03647579

Last Updated: 2019-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-30

Study Completion Date

2019-04-20

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.

Detailed Description

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Conditions

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Procedural Sedation and Analgesia During Bone Marrow Aspiration and Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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midazolam plus ketamine

Group Type ACTIVE_COMPARATOR

midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine

Intervention Type 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 plus ketamine

Group Type ACTIVE_COMPARATOR

Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed H Othman

Assisstant professor of Anesthesia ICU and pain Relief

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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South Egypt Cancer Institute, Assiut University

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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17100208

Identifier Type: -

Identifier Source: org_study_id

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