Reduce Nonsteroidal Antiinflammatory Drugs Doses for Analgesia After Sternotomy
Cardiac Surgery · Post-operative Pain
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 2
- Age range
- 18 years - 75 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 100 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
Currently, the management of pain after cardiac surgery is based on the concept of multimodal analgesia: Combined use of non-opioid analgesics associated with morphine intravenous analgesia by a system controlled by the patient (patient-controlled analgesia-PCA).
The combination of paracetamol and morphine PCA is very effective on pain at rest, but is limited on pain mobilization and causes the problem of side effects associated with opioid (overdose, sedation, respiratory depression, gastrointestinal intolerance, urinary retention ...) which are contributing factors to increase the length of stay in Intensive Care Unit, an additional cost of care and an increase postoperative morbidity and mortality.
Methods that have proved their effectiveness on pain and mobilization used in postoperative cardiac surgery are: anti-inflammatory drugs (NSAIDs) and / or loco-regional analgesia techniques. NSAIDs enhance analgesia produced by PCA Morphine and allow a reduction in morphine consumption, improved postoperative pain, decreased sedation and decreased postoperative morbidity and mortality.
Adverse effects of NSAIDs are commensurate with their time and exposure dose. Consequently, NSAIDs, in the absence of against-indications, should always be prescribed and used at the lowest effective dose and for the shortest possible time.
Some studies have suggested that lower doses of NSAIDs didn't appear to affect their effectiveness. At present, the investigators have no studies that address the hypothesis from which minimum dose of ketoprofen analgesic effect is obtained.
The investigators hypothesis is that lower dose ketoprofen may have efficacy on pain in the postoperative mobilization of cardiac surgery. The investigators want to find, in their study, this "optimal" ketoprofen dose which would be the minimum dose for clinical efficacy demonstrated dose.
This optimal dose could reduce the number of adverse effects of NSAIDs, but their study will probably not have enough power to prove it. NSAID use at these low doses, in postoperative cardiac surgery, could be extended to patient populations most at risk or for a duration longer than 48 hours.
Read the full description
To answer this hypothesis the investigators will consider starting a study of four groups of patients where appropriate doses to patient weight gradually increasing ketoprofen will be used in seeking the minimum effective dose.
Four groups will be determined by randomization. In all these groups, analgesia will be supplemented by a systematic standard self-administered treatment with morphine and paracetamol.
- Group 1 : Placebo group (P). 0 mg/kg ketoprofen IV every 6 hours for 48 hours (or 0 mg/kg every 24 hours) for 48 hours.
- Group 2 : "Ketoprofen quarter dose" (K ¼). 0,125 mg/kg ketoprofen IV every 6 hours (0,5 mg/kg every 24 hours) for 48 hours.
- Group 3 : "Ketoprofen half-dose" (K ½). 0,25 mg/kg ketoprofen IV every 6 hours (1 mg/kg every 24 hours) for 48 hours.
- Group 4 : "Ketoprofen full dose" (KPD). 0,5 mg/kg ketoprofen IV every 6 hours (or 2 mg/kg every 24 hours) for 48 hours.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Patients scheduled for a cardiac surgery (Coronary artery bypass graft, valve replacement)
- Age over 18 years
- Weight between 60 and 100 kg
- Absence of criteria for non-inclusion
Exclusion Criteria:
- Age over 75 years
- Renal insufficiency (MDRD \<60 ml / min)
- Hepatic Insufficiency
- Congestive heart failure (EF \<40%)
- Insulin-requiring diabetes
- Preoperative coagulation trouble
- History of peptic ulcer or gastrointestinal bleeding
- Allergy to NSAIDs
- Surgery in emergency, aorta surgery, heart transplantation
- Peptic ulcer scalable, history of peptic ulcer or recurrent bleeding (2 or more distinct episodes of bleeding or ulceration objectified)
- Pregnant or lactating women
- Major protected
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Double masked
placebo group
Group 1 : Placebo group (P). 0 mg/kg ketoprofen IV every 6 hours for 48 hours (or 0 mg/kg every 24 hours) for 48 hours
Drug: Ketoprofen
ketopofen quarter dose
Group 2 : "Ketoprofen quarter dose" (K ¼). 0,125 mg/kg ketoprofen IV every 6 hours (0,5 mg/kg every 24 hours) for 48 hours.
Drug: Ketoprofen
ketoprofen half-dose
Group 3 : "Ketoprofen half-dose" (K ½). 0,25 mg/kg ketoprofen IV every 6 hours (1 mg/kg every 24 hours) for 48 hours.
Drug: Ketoprofen
Ketoprofen full dose
Group 4 : "Ketoprofen full dose" (KPD). 0,5 mg/kg ketoprofen IV every 6 hours (or 2 mg/kg every 24 hours) for 48 hours
Drug: Ketoprofen
Ketoprofen DRUG
Not reported in this registry record.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Pain at the mobilization
Time frame: At the first 48 hours postoperatively
Pain at the mobilization of the first 48 hours postoperatively, measured every 4 hours by simple numerical scale or VAS (0: no pain to 10: unbearable pain)
Secondary measures
Demographic criteria
Time frame: at day 1
Not reported in this registry record.
Quantity of sufentanil administered intraoperatively
Time frame: at day 1
Not reported in this registry record.
Pain at rest measured by Visual Analogue Scale
Time frame: at day 1
Pain at rest measured every 4 hours from H0+4 hours to H+48 hours by Visual Analogue Scale (H0 : sedation stop time, 1 hour before waking)
Total morphine consumption
Time frame: from H0 to H0+48 hours
Not reported in this registry record.
Blood gas monitoring 3 times a day
Time frame: from H0 to H0+48 hours
Not reported in this registry record.
Time of removal of drains after surgery
Time frame: at day 1
Not reported in this registry record.
Resumption of transit characterized by the first gas time after surgery.
Time frame: at day 1
Not reported in this registry record.
Nausea occurrence (number of episodes) assessed every 4 hours
Time frame: from H0 to H0 +48 hours
Not reported in this registry record.
Vomiting occurrence (number of episodes) assessed every 4 hours
Time frame: from H0 to H0 +48 hours
Not reported in this registry record.
Effective Duration of stay in the Intensive Care Unit
Time frame: at day 1
Not reported in this registry record.
Patient satisfaction for its first mobilization assessed by simple scale Likert
Time frame: at H0+ 48 hours
Not reported in this registry record.
Occurrence of the following complications: Renal respiratory cardiac Neurological infectious Hemorrhagic
Time frame: From H0 to H0+48 hours
Not reported in this registry record.
Any readmission to the intensive care unit in the two weeks following the surgery
Time frame: at day 7
Not reported in this registry record.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
CHU de Clermont-FerrandClermont-Ferrand, FranceStatus unknown
Study team and timeline
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Study start
- Feb 1, 2014 Actual
- Primary completion
- Sep 1, 2016 Actual
- Study completion
- Sep 1, 2016 Actual
- First posted
- Jul 2, 2014 Estimated
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Reduce Nonsteroidal Antiinflammatory Drugs Doses for Analgesia After Sternotomy
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026