Analgesic and Sedative Effect of Fentanyl Versus Dexmedetomidine Infusion in Post-Operative Mechanically Ventilated Children After Open Abdominal Surgeries

Tanta University

Status: Completed

Conditions: Analgesic; Open Abdominal Surgeries; Fentanyl; Dexmedetomidine; Infusion; Sedative; Children; Mechanical Ventilation; Postoperative

Treatments: Drug: Fentanyl; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06994273

36264PR315/8/23

Details and patient eligibility

About

This study aimed to compare the efficacy and safety of fentanyl versus dexmedetomidine infusion in this population.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

Fentanyl group

Experimental group

Description:

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

Treatment:

Drug: Fentanyl

Dexmedetomidine group

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine