Heart Defects, CongenitalPhase 4MorphPedNCT07839273
Morphine Versus Fentanyl for Myocardial Protection in Acyanotic Children Undergoing Congenital Open-Heart Surgery
A Phase 4 study testing Fentanyl (IV) and morphine in people with Heart Defects, Congenital and Myocardial Reperfusion Injury, run by Baskent University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Heart Defects, Congenital, Myocardial Reperfusion Injury
- What is being tested?
- Fentanyl (IV) and morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2022to 20 Sep 2023
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Acyanotic children
- aged 1-6 years
- scheduled for elective congenital open-heart surgery requiring cardiopulmonary bypass
Who cannot join
- reoperative surgery,
- preoperative hemodynamic instability or inotropic support
- history of myocarditis, renal failure, congestive heart failure, hypertrophic cardiomyopathy, severe pulmonary disease requiring mechanical ventilation, pulmonary embolism, hypothyroidism, familial muscle disease
- known allergy to morphine or fentanyl
- prior cardioversion or cardiopulmonary resuscitation
- cyanotic heart disease
- age outside the 1-6 year range.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Refocusing On Morphine: Myocardial Protection Versus Fentanyl Via Pharmacological Conditioning In Acyanotic Pediatric Cardiac Surgery - A Randomized Controlled Trial
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.
Read more
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.
- Being tested
- Fentanyl (IV), morphine
- Keywords
- Congenital open heart surgery, acyanotic, anesthetic preconditioning, opioid, myocardial protection
- Medical subject headings
- Heart Defects, Congenital, Myocardial Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl (IV)Drug
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.
morphineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group fentanyl | Active comparator | 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. Receives: Drug: Fentanyl (IV) |
| Group morphine | Experimental | 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. Receives: Drug: morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of myocardial protection
-plasma malondialdehyde (ng/ml) levels
Measured: -Venous blood samples were collected at three time points: before skin incision (malondialdehyde1), at the end of surgery (malondialdehyde2), 6 hour postoperatively (malondialdehyde3)
comparison of myocardial protection
plasma glutathione (ng/ml) levels
Measured: Venous blood samples were collected at three time points: before skin incision (glutathione1), at the end of surgery (glutathione2), and 6 h postoperatively (glutathione3)
comparison of myocardial protection
echocardiographic parameters (left ventricular end-diastolic and end-systolic Z scores and EF (%))
Measured: Transthoracic echocardiography (TTE) was performed before skin incision and at 6 hours postoperatively
Secondary outcomes (8)
secondary outcome
-inotrope and vasopressor requirements (mcg/kg/min)
Measured: perioperatively
secondary outcome
mechanical ventilation duration (h)
Measured: from end of the surgery up to extubation
Secondary Outcome
opioid and sedative requirements (mcg, mg)
Measured: periprocedurally
Secondary Outcome
need for defibrillation (+/-)
Measured: perioperatively
Secondary Outcome
protamine-related hypersensitivity reactions (+/-)
Measured: perioperatively
Secondary Outcome
intensive care unit length of stay (day)
Measured: periprocedurally
Secondary Outcome
hospital length of stay (day)
Measured: periprocedurally
Secondary Outcome
30-day mortality rates (+/-)
Measured: from surgery up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start2 Sep 2022
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University Ankara Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839273
- Sponsor's protocol ID
- KA21/308
- Other IDs
- KA21/308
- Acronym
- MorphPed
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang R, Shen L, Xie Y, Gen L, Li X, Ji Q. Effect of morphine-induced postconditioning in corrections of tetralogy of fallot. J Cardiothorac Surg. 2013 Apr 11;8:76. doi: 10.1186/1749-8090-8-76.
PubMed 23577699Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Sherwani SS, Nisman M, Doroski V. Morphine-based cardiac anesthesia provides superior early recovery compared with fentanyl in elective cardiac surgery patients. Anesth Analg. 2009 Aug;109(2):311-9. doi: 10.1213/ane.0b013e3181a90adc.
PubMed 19608797Groban L, Butterworth J. Fentanyl: destiny or devil? Anesth Analg. 2009 Aug;109(2):301-2. doi: 10.1213/ane.0b013e3181a91944. No abstract available.
PubMed 19608795