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A Comparative Study of The Efficacy of Ketamine and Intravenous Dexmedetomidine in Preventing Agitation in Children with Cancer Before Biopsy and Bone Marrow Aspiration

A Comparative Study of The Efficacy of Ketamine and Intravenous Dexmedetomidine in Preventing Agitation in Children with Cancer Before Biopsy and Bone Marrow Aspiration

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240416061503N1
Enrollment
72
Registered
2024-04-19
Start date
2024-04-29
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation before aspiration and bone marrow biopsy. Restlessness and agitation

Interventions

Intervention 1: Intervention group: The Dexmedetomidine group received 2 µg/kg intravenously within 10 minutes before the biopsy procedure and bone marrow aspiration or intrathecal chemotherapy. The v

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1. All children aged 2 to 15 who are candidates for bone marrow biopsy and aspiration or intrathecal chemotherapy. 2.Obtaining informed consent from the patient (parents) 3. Absence of anatomical disorders in the patient's neck and spine 4. No history of heart, lung and kidney disease 5. No contraindications to LP

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
4-point scale of sedation. Timepoint: which is measured in 5, 10, 20, 30 minutes after drug injection. Method of measurement: 4-point degree of sedation is: restlessness: 4 awake: 3 drowsy: 2 asleep: 1. (In this scale, grades 1 and 2 are desirable.) This scale is measured based on the doctor's judgment during the examination.

Secondary

MeasureTime frame
Respiratory Rate. Timepoint: It is measured in 5, 10, 20, 30 minutes after drug injection. Method of measurement: Counting.;Blood pressure. Timepoint: It is measured in 5, 10, 20, 30 minutes after drug injection. Method of measurement: Pressure cuff.;Oxygen saturation. Timepoint: It is measured in 5, 10, 20, 30 minutes after drug injection. Method of measurement: Pulse oximetry.;Heart Rate. Timepoint: It is measured in 5, 10, 20, 30 minutes after drug injection. Method of measurement: Counting.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAtbin Latifi

Arak University of Medical Sciences

it@arakmu.ac.ir+98 86 3313 4715

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026