BACKGROUND: Inadequate pain management after cardiac surgery may result 10 in increased morbidity and length of hospital stay. Although opioids are the mainstay of postoperative analgesia, nonsteroidal anti-inflammatory drugs (NSAIDs) may be used instead to avoid the adverse effects (AEs) associated with opioids. Lornoxicam is a newly developed NSAID, the use of which is increasing. However, lornoxicam has not been studied for use in pain management after cardiac surgery. OBJECTIVE: The objective of this study was to compare the efficacy and tolerability 10 of lornoxicam and diclofenac sodium, an NSAID well established for use in pain management after major surgery, in pain management after coronary artery bypass grafting (CABG). METHODS: This single-blind, randomized, active-controlled study was conducted 10 at the Gaziantep University Hospital, Gaziantep, Turkey. Adult patients scheduled to undergo valve or CABG surgery for the first time were included. Patients were premedicated with diazepam 10 mg PO at 10 PM on the evening before surgery. General anesthesia was induced using fentanyl, midazolam, and propofol, and maintained using fentanyl and isoflurane in pure oxygen. After extubation and when they stated that they felt pain, patients were randomly assigned to 1 of 2 treatment groups: lornoxicam 8 mg IM q8h or diclofenac 75 mg IM q12h, for 48 hours. Meperidine 1 mg/kg IM was given for additional analgesia when needed (rescue medication). Pain relief was assessed using an I1-point visual analog scale (0 = no pain to 10 = worst pain imaginable) immediately before the first injection (baseline), and at 15 and 30 minutes and 1, 2, 3, 4, 6, 12, 18, 24, and 48 hours after the first injection. Sedation was assessed using a 5-point scale (0 = awake and alert to 4 = deep sedation) at the same time points. Tolerability was assessed by monitoring of AEs using patient interview and laboratory analyses. RESULTS:Forty patients were enrolled in the study (30 men, 10 women; 10 mean [SD] age, 54.4 [11.1 ] years; 20 patients per treatment group). The demographic and clinical characteristics and mean baseline pain relief scores were statistically similar between the 2 treatment groups. The mean pain relief scores at 15 and 30 minutes were statistically similar to baseline values in the 2 treatment groups. However, the mean pain relief scores at ≥1 hour after the first injection were significantly lower compared with baseline values (both groups, P < 0.05 at time points ≥1 hour). No significant between-group differences in mean pain relief scores were found at any time point. The overall mean pain relief scores were statistically similar between the 2 treatment groups. The mean sedation scores were significantly higher at 30 minutes, 1 hour, and 2 hours after the first injection in the diclofenac group compared with the lornoxicam group (all, P < 0.05). No AEs were observed. The need for rescue medication was statistically similar between the 2 treatment groups (lornoxicam, 2 patients; diclofenac, 3 patients). CONCLUSIONS: In this study of adult patients who underwentCABG, the efficacy 10 of lornoxicam and diclofenac were similar in postoperative pain management. Both study drugs were well tolerated.
RCT Entities:
BACKGROUND: Inadequate pain management after cardiac surgery may result 10 in increased morbidity and length of hospital stay. Although opioids are the mainstay of postoperative analgesia, nonsteroidal anti-inflammatory drugs (NSAIDs) may be used instead to avoid the adverse effects (AEs) associated with opioids. Lornoxicam is a newly developed NSAID, the use of which is increasing. However, lornoxicam has not been studied for use in pain management after cardiac surgery. OBJECTIVE: The objective of this study was to compare the efficacy and tolerability 10 of lornoxicam and diclofenac sodium, an NSAID well established for use in pain management after major surgery, in pain management after coronary artery bypass grafting (CABG). METHODS: This single-blind, randomized, active-controlled study was conducted 10 at the Gaziantep University Hospital, Gaziantep, Turkey. Adult patients scheduled to undergo valve or CABG surgery for the first time were included. Patients were premedicated with diazepam 10 mg PO at 10 PM on the evening before surgery. General anesthesia was induced using fentanyl, midazolam, and propofol, and maintained using fentanyl and isoflurane in pure oxygen. After extubation and when they stated that they felt pain, patients were randomly assigned to 1 of 2 treatment groups: lornoxicam 8 mg IM q8h or diclofenac 75 mg IM q12h, for 48 hours. Meperidine 1 mg/kg IM was given for additional analgesia when needed (rescue medication). Pain relief was assessed using an I1-point visual analog scale (0 = no pain to 10 = worst pain imaginable) immediately before the first injection (baseline), and at 15 and 30 minutes and 1, 2, 3, 4, 6, 12, 18, 24, and 48 hours after the first injection. Sedation was assessed using a 5-point scale (0 = awake and alert to 4 = deep sedation) at the same time points. Tolerability was assessed by monitoring of AEs using patient interview and laboratory analyses. RESULTS: Forty patients were enrolled in the study (30 men, 10 women; 10 mean [SD] age, 54.4 [11.1 ] years; 20 patients per treatment group). The demographic and clinical characteristics and mean baseline pain relief scores were statistically similar between the 2 treatment groups. The mean pain relief scores at 15 and 30 minutes were statistically similar to baseline values in the 2 treatment groups. However, the mean pain relief scores at ≥1 hour after the first injection were significantly lower compared with baseline values (both groups, P < 0.05 at time points ≥1 hour). No significant between-group differences in mean pain relief scores were found at any time point. The overall mean pain relief scores were statistically similar between the 2 treatment groups. The mean sedation scores were significantly higher at 30 minutes, 1 hour, and 2 hours after the first injection in the diclofenac group compared with the lornoxicam group (all, P < 0.05). No AEs were observed. The need for rescue medication was statistically similar between the 2 treatment groups (lornoxicam, 2 patients; diclofenac, 3 patients). CONCLUSIONS: In this study of adult patients who underwent CABG, the efficacy 10 of lornoxicam and diclofenac were similar in postoperative pain management. Both study drugs were well tolerated.