A Phase 2 interventional study of Ketoprofen in Cardiac Surgery and Post-operative Pain, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-07-02.
Sponsored by University Hospital, Clermont-Ferrand · Phase 2, Interventional, and Treatment
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.
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.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's planned enrollment of 100 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University Hospital, Clermont-Ferrand is the lead sponsor of 854 studies on the registry; 180 are open to participants now.
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Exclusion Criteria:
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
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
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
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
Pain at the mobilization
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)
Time frame: At the first 48 hours postoperatively
Demographic criteria
Time frame: at day 1
Quantity of sufentanil administered intraoperatively
Time frame: at day 1
Pain at rest measured by Visual Analogue Scale
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)
Time frame: at day 1
Total morphine consumption
Time frame: from H0 to H0+48 hours
Blood gas monitoring 3 times a day
Time frame: from H0 to H0+48 hours
Time of removal of drains after surgery
Time frame: at day 1
Resumption of transit characterized by the first gas time after surgery.
Time frame: at day 1
Nausea occurrence (number of episodes) assessed every 4 hours
Time frame: from H0 to H0 +48 hours
Vomiting occurrence (number of episodes) assessed every 4 hours
Time frame: from H0 to H0 +48 hours
Effective Duration of stay in the Intensive Care Unit
Time frame: at day 1
Patient satisfaction for its first mobilization assessed by simple scale Likert
Time frame: at H0+ 48 hours
Occurrence of the following complications: Renal respiratory cardiac Neurological infectious Hemorrhagic
Time frame: From H0 to H0+48 hours
Any readmission to the intensive care unit in the two weeks following the surgery
Time frame: at day 7
The record gives a start of Feb 2014, a primary completion of Aug 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ketoprofen
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