Abstract

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). 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. 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).Key words: Non-steroidal anti-inflammatory drugs, ketoprofen, cyclooxygenase, pain, postoperative, sternotomy, postoperative rehabilitation, analgesia, side effects.

MeSH

Morphine, Pain, Postoperative, Heart, Pharmaceutical Preparations, Ketoprofen, Anti-Inflammatory Agents, Non-Steroidal

Cited by

• Effects of peri-operative nonsteroidal anti-inflammatory drugs on post-operative kidney function for adults with normal kidney function. Cochrane Database Syst Rev, 2019
• The Impact of Opioid-Sparing Analgesia on Postoperative Pain and Recovery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Pain Ther, 2025