OBJECTIVE(S): To assess the effectiveness and side effects of a patient-controlled sublingual sufentanil tablet system for postoperative analgesia after cardiac surgery and to compare it to a nurse-controlled continuous morphine infusion.
DESIGN: Prospective, open-label, randomized controlled trial.
SETTING: Single university academic center.
PARTICIPANTS: Adult patients undergoing cardiac surgery, which included a sternotomy.
INTERVENTIONS: Sublingual sufentanil tablet system versus nurse-controlled continuous morphine infusion.
MEASUREMENTS AND MAIN RESULTS: A total of 483 cardiac surgery patients were screened for eligibility, of whom 64 patients completed the study. No statistically significant differences were found for baseline characteristics between both groups. All mean numeric rating scale (NRS) pain scores from after extubation until intensive care unit discharge were ≤3 in both groups. The cumulative mean NRS pain score from 24 hours after extubation (primary outcome) (t = hours after extubation) was significantly different in favor of the morphine group: (t = 0-24) (0.8 [0.7] v 1.3 [0.8]; p = 0.006). Later cumulative mean pain scores were also in favor of the morphine group: (t = 24-48) (0.2 [0.3] v 0.6 [0.5]; p = 0.001) and (t = 48-63) (0.0 [0.0] v 0.1 [0.2]; p = 0.013). The cumulative opioid dose (in milligrams intravenous morphine equivalents) was significantly higher in the morphine group compared with the sublingual sufentanil group (241.94 [218.73] v 39.84 [21.96]; p = 0.0001). No differences were found for the incidences of postoperative nausea and vomiting, sedation, hypoventilation, bradycardia, or hypotension between both groups (secondary outcomes).
CONCLUSIONS: Despite resulting in statistically significantly higher pain scores, a patient-controlled sublingual sufentanil tablet system offers adequate analgesia after cardiac surgery and reduces opioid consumption when compared with continuous morphine infusion.