Condition 1: Restlessness of patients being weaned from ventilator in PICU. Condition 2: Dependence on sedative hypnotics. Dependence on respirator [ventilator] status Sedative, hypnotic or anxiolytic dependence, uncomplicated
Conditions
Interventions
Intervention 1: Control group: In 10 patients who have been treated with midazolam and fentanyl for more than 5 days and are being weaned from the ventilator
according to diagnosis of pediatric pulmonologist, dose of midazolam and fentanyl will be reduced 10 to 25% per day based on patient's tolerance
at first dose of midazolam will be stopped and then fentanyl. Intervention 2: Experimental group: In 10 patients who have been treated with midazolam and fentanyl for more than 5 days and are being w
according to the diagnosis of pediatric pulmonologist, 24 hours before tapering midazolam and fentanyl, dexmedetomidine will be started at a dose of 0.2 to 0.5 mcg/kg/hour after 24 hours, midazolam an
then the dose of dexmedetomidine will be reduced 0.1 mcg/kg/hour depending on the patient's tolerance every 12 to 24 hours.
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Months to 18 Years
Inclusion criteria
Inclusion criteria: Receiving midazolam and fentanyl as sedatives hypnotics Children are being weaned from the ventilator
Exclusion criteria
Exclusion criteria: Decreasing blood pressure according to age range Bradycardia according to age range
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Reducing duration of the patient's weaning from the ventilator. Timepoint: Daily. Method of measurement: Demographic data including age, sex, weight, BMI and clinical data including blood pressure, respiration rate, oxygen saturation and body temperature; also data related to patients' blood gases will be recorded and compared in two groups. | — |
Primary
| Measure | Time frame |
|---|---|
| Reducing restlessness signs and symptoms in children; According to the Richmond Agitation-Sedation Scale (RASS), the patient's clinical score should be "zero". Timepoint: Daily. Method of measurement: The Richmond Scale is used to assess the reduction of restlessness symptoms and signs. According to this scale the "zero" clinical score indicates alert and calm patient.;Reducing the restlessness symptoms and signs in children that according to the Ramsay scale the patient's clinical score should be "two". Timepoint: Daily. Method of measurement: Data related to the patients' restlessness will be assessed and recorded using the Ramsay sedation scale and compared between two groups." two" clinical score indicates that the patient is awake, corporative, oriented, and tranquil.;Reducing restlessness symptoms in children, that is considered due to patient's clinical score in the Finnegan Neonatal Abstinence scores scale. Timepoint: Daily. Method of measurement: According to Finnegan Neonatal Abstinence scoring system, the patient's clinical score for autonomic nervous system, metabolic and gastrointestinal disorders will be recorded and assessed. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatemeh Ghafuryan
Tabriz University of Medical Sciences
Outcome results
None listed