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

A

Assiut University

Status

Completed

Conditions

Procedural Sedation and Analgesia During Bone Marrow Aspiration and Biopsy

Treatments

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

Funder types

Other

Identifiers

NCT03647579
17100208

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

3 to 12 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

midazolam plus ketamine
Active Comparator group
Treatment:
Drug: midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine
dexmedetomidine plus ketamine
Active Comparator group
Treatment:
Drug: Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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