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

Procedural Sedation and Analgesia During Bone Marrow Aspiration and Biopsy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03647579
• Other study ID #: 17100208
• Status: Completed
• Phase: N/A
• Start date: August 30, 2018
• Est. completion date: April 20, 2019

Study information

• Verified date: October 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 20, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Procedural Sedation and Analgesia During Bone Marrow Aspiration and Biopsy

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	South Egypt Cancer Institute, Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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