Comparative study of dexmedetomidine-fentanyl vs. midazolam-ketamine in sedation in children undergoing bone marrow biopsy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160301026866N11

Enrollment

Registered

2020-06-23

Start date

2020-05-21

Completion date

Unknown

Last updated

2020-07-13

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

Conditions

None listed

Interventions

Intervention 1: Intervention group: Sedation with 2 micrograms / kg fentanyl plus 2 micrograms / kg dexmedetomidine intravenously. Intervention 2: Control group: sedation with 0.1 mg / kg midazolam pl

Eligibility

Sex/Gender

All

Age

2 Years to 6 Years

Inclusion criteria

Inclusion criteria: Children 2 to 6 years of age ASA I and ASA II classes , bone marrow biopsy candidates

Exclusion criteria

Exclusion criteria: Congenital heart and respiratory disease productive cough fever wheezing or cracking in the lungs parental withdrawal from the project

Design outcomes

Primary

Measure	Time frame
Sedation Score. Timepoint: Immediately before prescribing the drug, 2,5,10,15 minutes after drug administration. Method of measurement: Ramsay Scale.;Mean Arterial Blood pressure. Timepoint: Immediately before prescribing the drug, 2, 5 ,10,15 minutes after drug administration. Method of measurement: Anesthesia monitoring device.;Heart Rate. Timepoint: Immediately before prescribing the drug, 2, 5,10,15 minutes after drug administration. Method of measurement: Anesthesia monitoring device.	—

Measure

Time frame

Sedation Score. Timepoint: Immediately before prescribing the drug, 2,5,10,15 minutes after drug administration. Method of measurement: Ramsay Scale.;Mean Arterial Blood pressure. Timepoint: Immediately before prescribing the drug, 2, 5 ,10,15 minutes after drug administration. Method of measurement: Anesthesia monitoring device.;Heart Rate. Timepoint: Immediately before prescribing the drug, 2, 5,10,15 minutes after drug administration. Method of measurement: Anesthesia monitoring device.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Shafa

Shahid Beheshti University of Medical Sciences

shafa_amir@yahoo.com+98 21 2222 7021

Outcome results