New painkiller could rival morphine after heart surgery
NCT ID NCT07451522
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new pain medicine called tafalgin against morphine in 100 adults recovering from coronary artery bypass grafting (CABG). Participants receive either a single shot of morphine or tafalgin when their pain level is high. The goal is to see if tafalgin controls pain just as well, while causing fewer side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * ASA score less then 3, Signed inform consent, Absence of preoperative drugs administration that affects patient's perception of pain, No active infection process, BMI index \>18,5 kg\\m2 and \< 35 kg/m2, CABG, Age 18-75 years Exclusion Criteria (the presence of at least one is sufficient): * Failure to meet the inclusion criteria. * High severity according to ASA (class IV or higher), which is associated with a high probability of prolonged mechanical ventilation, hemodynamic instability, and inability to use drugs affecting cardiac output and/or total peripheral vascular resistance. * Contraindications to the use of tafalgin and/or morphine in accordance with the approved Summary of Product Characteristics (hypersensitivity to tafalgin, morphine, other opioids, or any excipients). * Pregnancy or lactation. * Acute or prolonged chronic intoxication with drugs or substances depressing the central nervous system (alcohol, barbiturates, opioid drugs, benzodiazepines). * Use of monoamine oxidase inhibitors (MAOIs) or less than 14 days since their discontinuation. * Liver cirrhosis, Child-Pugh class C. * Acute renal failure requiring renal replacement therapy. * Unresected malignant neoplasm. * Mesenteric thrombosis or another severe abdominal pain syndrome of unclear etiology at the time of inclusion. * Simultaneous participation in another clinical study. * Marked CNS depression due to any cause, except for acute poisoning. * COPD stage III and/or bronchial asthma in the exacerbation phase. * Any clinically significant condition, disease, or circumstance in the medical history that, in the opinion of the investigator, precludes participation in the study. * Psychiatric, physical, or other conditions preventing adequate assessment of the patient's behavior or proper compliance with the study protocol. * Postoperative hemodynamic instability requiring high-dose inotropic and/or vasopressor support (epinephrine \> 0.1 μg/kg/min, dopamine \> 10 μg/kg/min, norepinephrine \> 0.2 μg/kg/min) and/or mechanical circulatory support. * Refusal to participate in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Primorsky Regional General Hospital #1
RECRUITINGVladivostok, Outside US, 690091, Russia
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