NCT06994273

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 4 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Analgesic
• Sedative
• Fentanyl
• Dexmedetomidine
• Infusion
• Postoperative
• Mechanical Ventilation
• Children
• Open Abdominal Surgeries

Interventions

Type	Name	Description
DRUG	Fentanyl	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.
DRUG	Dexmedetomidine	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.

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2025-05-29
• Last updated: 2025-05-29

Locations

1 site across 1 country: Egypt