Nefopam for Analgesia Following Cardiac Surgery: A Randomized Placebo-Controlled Double-Blind Clinical Trial
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Issued Date
2025-01-01
Resource Type
ISSN
10530770
eISSN
15328422
Scopus ID
2-s2.0-105011254443
Journal Title
Journal of Cardiothoracic and Vascular Anesthesia
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SCOPUS
Bibliographic Citation
Journal of Cardiothoracic and Vascular Anesthesia (2025)
Suggested Citation
Vacharaksa K., Kongkanond T., Taechawattananan N., Weinberg L., Lertkovit S., Subtaweesin T., Saraphang S., Kitisin N., Raykateeraroj N. Nefopam for Analgesia Following Cardiac Surgery: A Randomized Placebo-Controlled Double-Blind Clinical Trial. Journal of Cardiothoracic and Vascular Anesthesia (2025). doi:10.1053/j.jvca.2025.06.037 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/111429
Title
Nefopam for Analgesia Following Cardiac Surgery: A Randomized Placebo-Controlled Double-Blind Clinical Trial
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Corresponding Author(s)
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Abstract
Objective: To evaluate the analgesic efficacy, opioid-sparing effects, and safety profile of nefopam compared with placebo following elective cardiac surgery. Design: Randomized, double-blind, placebo-controlled trial at a tertiary care center. Setting: Perioperative care. Participants: A total of 103 adults (mean age, 57.9 ± 11.3 years) undergoing elective cardiac surgery via median sternotomy were randomized to receive nefopam (n = 50) or placebo (n = 53). Interventions: Patients were randomized to receive nefopam (20 mg intravenous [IV] bolus, followed by an 80 mg continuous infusion over 24 hours) or placebo, with both groups receiving standardized IV fentanyl via patient-controlled analgesia. Measurements and Main Results: The primary outcome was cumulative fentanyl consumption over 48 hours. Secondary outcomes included pain scores (NRS 0-10), intubation duration, intensive care unit (ICU)/hospital length of stay, and adverse events. Both fentanyl consumption and pain scores were assessed at 3, 6, 12, 24, and 48 hours postoperatively. The nefopam group consumed 25% less fentanyl over 48 hours (mean, 16.3 ± 1.6 µg/kg vs 21.9 ± 1.6 µg/kg; p = 0.014), with significant reductions from 6 hours to 48 hours. Pain scores were lower in the nefopam group at rest at 48 hours (p = 0.03) and during movement at 24 and 48 hours (p = 0.04 and 0.01), although overall pain remained mild. Adverse events (eg, sinus tachycardia, agitation/delirium) were comparable in the 2 groups. Duration of intubation and ICU/hospital length of stay did not differ between the 2 groups. Conclusions: Nefopam was well tolerated and associated with statistically significant but clinically modest reductions in fentanyl use and pain scores after cardiac surgery, supporting its role as a safe adjunct in multimodal analgesia.