Background: Non-steroidal anti-inflammatory drugs (NSAIDs) can reduce postoperative pain, in
both static (i.e., at rest) and dynamic contexts (e.g., during coughing or mobilization), and reduced
doses could improve their efficacy/tolerance balance.
Objectives: To test this hypothesis of efficacy after open heart surgery, in which NSAIDs are
poorly used, particularly for safety concerns.
Study Design: Randomized, double-blind trial.
Setting: Single-center, French university hospital.
Methods: Patients. One hundred patients at low risk of postoperative complications undergoing
scheduled open heart surgery (97 analyzed). Intervention. We tested intravenous ketoprofen, at a
dose of 0.5 mg/kg-1 every 6 hours during the 48 hours following the end of sedation, after surgery.
This standard protocol was compared to a similar one in which half doses were administered, to one
with quarter doses, as well as to a placebo group. Analgesia was supplemented by acetaminophen
plus self- and nurse-administered intravenous morphine. Measurement. The primary outcome was
the intensity of dynamic pain, assessed over 48 hours on an 11-point numerical rating scale (NRS).
Results: Only the full-dose ketoprofen group showed reduced dynamic and static postoperative
pain vs. placebo (P < 0.00001 for both). The evolution of dynamic pain suggested a delayed
and therefore non-significant effect with the low doses. Ketoprofen did not affect either the
postoperative morphine consumption or the tolerance outcomes, such as the volumes of chest
tube drainage and the renal function.
Limitations: This pilot trial was undersized to test major tolerance outcomes.
Conclusions: Although we failed to demonstrate any analgesic effects with low doses of
ketoprofen, we confirmed the good efficacy/tolerance balance with this propionic NSAID of
intermediate COX2
-selectivity. Lower doses of NSAIDs, potentiated by a loading dose, should be
tested in the future.
IRB approval: CPP Sud-Est VI (Clermont-Ferrand, France), on 12/23/2013.
Clinical trial registry: EudraCT (2013-003878-27); ClinicalTrials.gov (NCT02180087)
Effect of Music on Postoperative Pain in Patients Under Open Heart Surgery