Comparison of the effect of dexmedetomidine and midazolam on the prevention of agitation before aspiration and bone marrow biopsy

: A Comparative Study of the Effect of Dexmedmotidine and Midazolam on Prevention of Agitation Before Bone Marrow Aspiration and Bone Marrow Biopsy and Intracranial Chemo Therapy in Cancerous Children

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191104045328N9

Enrollment

Registered

2022-03-03

Start date

2022-04-05

Completion date

Unknown

Last updated

2022-03-08

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: 45 children 2 to 15 years of age who receive a 5-minute intravenous infusion of 2 micrograms per kilogram of dexmedetomidine intravenously before performing a biops

Eligibility

Sex/Gender

All

Age

2 Years to 15 Years

Inclusion criteria

Inclusion criteria: All children 2 to 15 years old who are candidates for bone marrow biopsy and aspiration or intrathecal chemotherapy. Obtaining informed consent from the patient (parents)

Exclusion criteria

Exclusion criteria: Contraindication of lumbar puncture History of cardiopulmonary and renal disease Existence of anatomical disorders in the patient's neck and spine

Design outcomes

Primary

Measure	Time frame
4-point sedation scale. Timepoint: 4-point sedation scale measured at 5, 10, 20, 30 minutes after drug injection. Method of measurement: 4-point sedation scale include: Restlessness: 4 Awakening: 3 Sleepy: 2 Sleeping: 1. (Which are desirable in this scale of 1st and 2nd degree.) This scale is measured based on the judgment of the doctor in the examination.;Respiratory rate per minute. Timepoint: measured at 5, 10, 20, 30 minutes after drug injection. Method of measurement: Counting.;Blood pressure. Timepoint: measured at 5, 10, 20, 30 minutes after drug injection. Method of measurement: Barometer cuff.;Oxygen saturation. Timepoint: measured at 5, 10, 20, 30 minutes after drug injection. Method of measurement: Pulse oximetry.;Heart rate per minute. Timepoint: measured at 5, 10, 20, 30 minutes after drug injection. Method of measurement: Counting.	—

Measure

Time frame

4-point sedation scale. Timepoint: 4-point sedation scale measured at 5, 10, 20, 30 minutes after drug injection. Method of measurement: 4-point sedation scale include: Restlessness: 4 Awakening: 3 Sleepy: 2 Sleeping: 1. (Which are desirable in this scale of 1st and 2nd degree.) This scale is measured based on the judgment of the doctor in the examination.;Respiratory rate per minute. Timepoint: measured at 5, 10, 20, 30 minutes after drug injection. Method of measurement: Counting.;Blood pressure. Timepoint: measured at 5, 10, 20, 30 minutes after drug injection. Method of measurement: Barometer cuff.;Oxygen saturation. Timepoint: measured at 5, 10, 20, 30 minutes after drug injection. Method of measurement: Pulse oximetry.;Heart rate per minute. Timepoint: measured at 5, 10, 20, 30 minutes after drug injection. Method of measurement: Counting.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Vahid Falahati

Arak University of Medical Sciences

vahidfalahati@arakmu.ac.ir+98 86 3222 2003

Outcome results

None listed

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