Analgesic, Children, Dexmedetomidine, Fentanyl, Infusion, Mechanical Ventilation, Open Abdominal Surgeries, Postoperative, Sedative
Conditions
Brief summary
This study aimed to compare the efficacy and safety of fentanyl versus dexmedetomidine infusion in this population.
Detailed description
Appropriate sedation and analgesia are essential components in the post-operative care of critically ill children in the pediatric intensive care unit (PICU), especially those who need mechanical ventilation. Fentanyl is an opioid analgesic that is 50-100 times more potent than morphine. It is used frequently because of its ability to provide rapid analgesia. A single dose of fentanyl significantly reduced pain behaviors and changes in heart rate. It also increased the growth hormone level. Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with significant sedative and analgesic effects. Some studies have investigated its role in adult and pediatric intensive care, as a primary sedative or a second line following failure of benzodiazepines or opioid sedation, as a bridge for extubation, for substance withdrawal, and to decrease intensive care unit (ICU) delirium.
Interventions
DRUGFentanyl
Patients received fentanyl as a 1 μg/kg bolus over 10 min, followed by a 1-5 μg/kg/hr intravenous infusion after 10-15 minutes.
DRUGDexmedetomidine
Patients received dexmedetomidine as a 1 μg/kg bolus over 10 min, followed by a 0.2-0.7 μg/kg/hr intravenous infusion after 10-15 minutes.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Age from 4 to 11 years. * Both sexes. * Children who required a minimum of 24 hrs of mechanical ventilation following open abdominal surgeries
Exclusion criteria
* Patients with significant congenital anomalies. * Chromosomal abnormalities. * Neurologic conditions prohibiting sedation evaluation. * Neuromuscular diseases. * Those receiving neuromuscular blockers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weaning eligibility | 48 hours postoperatively | The time from ventilator weaning eligibility was monitored until discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from eligibility to extubation | 60 min postoperatively | Time from eligibility to extubation was monitored until discharge. |
| Mean arterial pressure | 48 hours post-infusion initiation | Mean arterial pressure was continuously monitored and recorded at baseline and 2, 5, 10, 15, 30 minutes, 2, 6, 12, 24, and 48 hrs post-infusion initiation. |
| Heart rate | 48 hours post-infusion initiation | Heart rate was continuously monitored and recorded at baseline and 2, 5, 10, 15, 30 minutes, 2, 6, 12, 24, and 48 hrs post-infusion initiation. |
Countries
Egypt
Outcome results
None listed