Informations générales (source: ClinicalTrials.gov)
Reduce Nonsteroidal Antiinflammatory Drugs Doses for Analgesia After Sternotomy (LoDoNSAID)
Interventional
Phase 2
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
février 2014
septembre 2015
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Patrick LACARIN | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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