Status:
UNKNOWN
Tapentadol Versus Tramadol Analgesia Post Cardiac Surgery
Lead Sponsor:
Aretaieion University Hospital
Conditions:
Postoperative Pain
Surgery
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of this randomized one-blinded study will be to evaluate the efficacy and tolerability of two different oral doses of tapentadol and compare it to tramadol (an opioid commonly used to treat po...
Detailed Description
Management of post-surgical pain is a daily challenge for every anaesthetist. Undertreated post-surgical pain can result in cardiovascular, pulmonary and gastrointestinal complications, as well as chr...
Eligibility Criteria
Inclusion
- age \<75 years old
- patients discharged from Intensive Care Unit (ICU) in less than 30 hours
- elective cardiac surgery
Exclusion
- hepatic failure (increased transaminase levels
- renal failure (creatinine\> 2 mg/dL)
- ileus
- emergency surgery (hemorrhage, tamponade, aortic dissection)
- readmission in ICU
- treatment with monoaminoxidase inhibitors, selective serotonine reuptake inhibitors or antiepileptics
- age\>75 years old
- communication or language barriers
- Lack of informed consent
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04718116
Start Date
November 1 2022
End Date
December 31 2024
Last Update
February 8 2023
Active Locations (2)
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1
Onassis Cardiac Surgery Centre
Athens, Greece, 17674
2
Ygeia General Hospital of Athens
Athens, Greece