Comparison of effectiveness of dexmedetomidine plus Midazolam and fentanyl plus Midazolam in placement of central venous catheter in PICU

Comparison of effectiveness of dexmedetomidine plus Midazolam and fentanyl plus Midazolam in placement of central venous catheter in Pediatric Intensive Care Unit (PICU)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230701058628N2

Enrollment

Registered

2023-07-27

Start date

2023-03-21

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Condition 1: Viral infection. Condition 2: Acute lower respiratory infection. Condition 3: Virus infections of central nervous system. Condition 4: Immunodeficiency. Condition 5: Renal failure requiring dialysis or plasmaphresis. Viral infection of unspecified site Unspecified acute lower respiratory infection Atypical virus infections of central nervous system Immunodeficiency, unspecified Congenital renal failure

Interventions

Intervention 1: Intervention group: In the intervention group, 1 µg/kg intravenous dexmedetomidine is prescribed for ten minutes along with 0.1 mg/kg injectable midazolam as a loading dose. Dexmedetom

Eligibility

Sex/Gender

All

Age

1 Months to 18 Years

Inclusion criteria

Inclusion criteria: Children needing central venous catheter placement in the pediatric intensive care unit

Exclusion criteria

Exclusion criteria: Presence of bradycardia or hypotension High blood pressure above the 99th percentile Apnea before the study The presence of cardiac conduction disorder in the electrocardiogram before drug administration Patients with American Society of Anaesthesiologists' physical status classification III or higher Known kidney or heart failure History of heart surgery Shock Receiving other anesthetics, sedatives, injectable painkillers

Design outcomes

Primary

Measure	Time frame
Ramsay Sedation Score equal to or more than 3. Timepoint: Every 5 minutes until 5 minutes after sedation. Method of measurement: Ramsay scale.;Mean arterial blood pressure. Timepoint: Every 5 minutes until 5 minutes after sedation. Method of measurement: Blood pressure monitor.;Blood oxygen saturation. Timepoint: Every 5 minutes until 5 minutes after sedation. Method of measurement: Palsoxymeter.;Heart rate and respiratory rate. Timepoint: Every 5 minutes until 5 minutes after sedation. Method of measurement: ????? ?? ?????.	—

Measure

Time frame

Ramsay Sedation Score equal to or more than 3. Timepoint: Every 5 minutes until 5 minutes after sedation. Method of measurement: Ramsay scale.;Mean arterial blood pressure. Timepoint: Every 5 minutes until 5 minutes after sedation. Method of measurement: Blood pressure monitor.;Blood oxygen saturation. Timepoint: Every 5 minutes until 5 minutes after sedation. Method of measurement: Palsoxymeter.;Heart rate and respiratory rate. Timepoint: Every 5 minutes until 5 minutes after sedation. Method of measurement: ????? ?? ?????.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Fahimeh Dianati

Mazandaran University of Medical Sciences

pidrc@mazums.ac.ir+98 11 3334 2334

Outcome results

None listed

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