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COMPLETED
NCT07839273
PHASE4

Morphine Versus Fentanyl for Myocardial Protection in Acyanotic Children Undergoing Congenital Open-Heart Surgery

Sponsor: Baskent University

View on ClinicalTrials.gov

Summary

This study compared two opioid pain medications - morphine and fentanyl - used during open-heart surgery in young children born with heart defects (congenital heart disease). During open-heart surgery, the heart is temporarily stopped to allow surgeons to repair the defect. This process can cause damage to the heart muscle due to reduced blood flow and its restoration, known as ischemia-reperfusion injury, which is one of the leading causes of complications in children undergoing heart surgery. Morphine is known to activate specific receptors in the heart that may help protect it against this type of injury - a process called pharmacological preconditioning. While fentanyl has largely replaced morphine in pediatric cardiac anesthesia over the years, emerging evidence suggests that morphine may have unique heart-protective properties that fentanyl lacks. The purpose of this study was to investigate whether morphine provides better heart muscle protection than fentanyl in children with non-cyanotic congenital heart disease undergoing elective open-heart surgery. The study also aimed to compare postoperative recovery, need for heart-supporting medications, and other clinical outcomes between the two groups.

Official title: Refocusing On Morphine: Myocardial Protection Versus Fentanyl Via Pharmacological Conditioning In Acyanotic Pediatric Cardiac Surgery - A Randomized Controlled Trial

Key Details

Gender

All

Age Range

1 Year - 6 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2022-09-02

Completion Date

2023-09-20

Last Updated

2026-09-24

Healthy Volunteers

No

Interventions

DRUG

Fentanyl (IV)

Patients received fentanyl 1.5 µg/kg intravenously at anesthesia induction, followed by 1.5 µg/kg before skin incision, with maintenance via continuous infusion at 1 µg/kg/h throughout surgery.

DRUG

morphine

Patients received morphine 0.15 mg/kg intravenously at anesthesia induction, followed by 0.15 mg/kg before skin incision, with maintenance via continuous infusion at 0.1 mg/kg/h throughout surgery.

Locations (1)

Baskent Universityy Ankara Hospital

Ankara, Turkey (Türkiye)