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

Not Applicable

Completed

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

• Registration Number: NCT06994273
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-05-28
• Last Update Submitted: 2025-05-28
• Study First Posted: 2025-05-29
• Last Update Posted: 2025-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl group	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
Dexmedetomidine group	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.

Primary Outcome Measures

Name	Time	Method
Weaning eligibility	48 hours postoperatively	The time from ventilator weaning eligibility was monitored until discharge.

Secondary Outcome Measures

Name	Time	Method
Time from eligibility to extubation	60 min postoperatively	Time from eligibility to extubation was monitored until discharge.
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.
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.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt