Efficacy of Moderate Sedation for Pain Control in Patients Undergoing Extracorporeal Shock Wave Lithotripsy: a Randomized Clinical Trial

Abstract

Introduction: Extracorporeal shock wave lithotripsy (ESWL) is a painful procedure. Effective analgesia is mandatory to achieve patient comfort and in cooperating according to the treatment plan. The objective of the study is to evaluate pain relief from moderate to severe (pain score, PS ≥4) to mild pain (PS 0-3) with parenteral propofol-fentanyl (moderate sedation) and preemptive etoricoxib combined with acetaminophen (conventional treatment) during ESWL. Methods: Seventy patients scheduled for ESWL were randomized by a computer program and sealed envelope. Thirty-five samples were assigned to propofol-fentanyl (PF) as the experimental group, and thirty-five samples were assigned to etoricoxib-acetaminophen (EA) as the control group. The primary outcome was to evaluate the efficacy of moderate sedation for pain control. Pain was assessed using an 11-point numeric rating scale (NRS) and ≤3 was considered adequate analgesia. Secondary outcomes included complications, recovery time, health care and patient satisfaction using the Modified Aldrete score, Modified Post-anesthesia Discharge Scoring System (PADSS) and visual analog scale (VAS) for satisfaction Results: Sixty-eight patients completed the present study, with no differences in demo- graphics data or baseline vital signs. Group PF reported less PS than group EA (P<0.001). After ranging the severity of pain, moderate to severe pain was 2 (5.9%) and 29 (85.3%), respectively (P<0.001). All patients underwent a planned ESWL without major complications. Most patients achieved a Modified Aldrete score ≥9 within 5 min of the end of ESWL. Although the recovery time of group PF was slower than group EA, it was not clinically significant. The median time for patients to achieve PADSS ≥10 was 10 and 0 min, and the median time for patients to feel full recovery was 40 and 5 min, respectively (P<0.001). Furthermore, group PF had better overall satisfaction than group EA. Conclusion: A combination of propofol and fentanyl for moderate sedation can provide effective anesthesia during ESWL. Furthermore, it facilitates ESWL to be established plan, safely and increases overall satisfaction.