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Comparison of the effect of midazolam, fentanyl, and combination of them on the frequency of self-extubation

Comparrison of the effect of midazolam, fentanyl and their combination on the frequency of self-extubation among children admitted to the intensive care unit

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201611159475N2
Enrollment
200
Registered
2017-02-12
Start date
2015-10-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

weaning from mechanical ventilation. Other specified medical care

Interventions

Intervention 1: Control group: Intravenous Midazolam alone at the dose of 0.15 mg/kg/hour in order to keep the Ramsay score between 2 and 3 during the mechanical ventilation. Intervention 2: Intervent
Treatment - Drugs
Control group: Intravenous Midazolam alone at the dose of 0.15 mg/kg/hour in order to keep the Ramsay score between 2 and 3 during the mechanical ventilation.
Intervention group 1: Intravenous fentanyl alone at the dose of 1-3 mcg/kg/hour in order to keep the Ramsay score between 2 and 3 during the mechanical ventilation.
Intervention group 2: this group receives Midazolam at the dose of 0.15 mg/kg/hour and intravenous fentanyl at the dose of 1-3 mcg/kg/hour in order to keep the Ramsay score between 2 and 3 during the

Sponsors

Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Months to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: pediatric ICU patients who are under mechanical ventilation who have normal consciousness level. Exclusion criteria: difficult airway management defined as the airway with a structural abnormality including cleft palate and Pierre Robin syndrome; systemic disorders that affect intubation (Mucopolysaccharidosis); Mallampati score over 2; Patients with unstable hemodynamics.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Number of self extubation. Timepoint: during mechanical ventilation. Method of measurement: report.

Secondary

MeasureTime frame
The number of days under mechanical ventilation. Timepoint: during hospitalization in intensive care unit. Method of measurement: report.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Sajad Razavi

Shahid Beheshti University of medical sciences

sajadrazavi@yahoo.com+98 21 2293 1924

Outcome results

None listed

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