COMPARATIVE RANDOMIZED CONTROLLED STUDY OF ANALGESIC EFFECT BETWEEN ORAL COMBINATION ANALGESIA AND INTRAVENOUS ANALGESIA IN PATIENTS UNDERGOING EXTRACORPOREAL SHOCKWAVE LITHOTRIPSY AT PHRAMONGKUTKLAO HOSPITAL
DOI:
https://doi.org/10.55374/jseamed.v9.232Keywords:
ESWL, oral analgesia, KUB stone, Extracorporeal shockwave lithotripsy, Paracetamol, Ibuprofen, Tramadol, Fentanyl, Pain controlAbstract
Background: Extracorporeal Shockwave Lithotripsy (ESWL) is a widely used, noninvasive treatment for upper urinary tract stones. Despite its routine use, patients often experience significant pain during the procedure, and opioid-based analgesia such as intravenous fentanyl may lead to adverse effects. Optimizing pain control while minimizing opioid exposure remains a clinical challenge.
Objectives: To compare the analgesic efficacy and side effect profiles of three analgesic regimens during ESWL: intravenous fentanyl alone, a combination of oral and intravenous analgesics, and oral analgesics alone.
Methods: This randomized clinical trial included 78 ESWL sessions from 72 patients with renal or ureteric stones. Patients were randomized into three groups: Group A received intravenous fentanyl (50 µg); Group B received oral paracetamol (500 mg) and ibuprofen (400 mg) plus intravenous fentanyl (50 µg); Group C received oral tramadol (50 mg), paracetamol (500 mg), and ibuprofen (400 mg). A rescue dose of intravenous fentanyl 50 µg was offered when a patient reported an NRS score > 8 or was unable to tolerate the pain. The primary outcome was pain intensity, measured using the 11-point Numeric Rating Scale (NRS; 0 = no pain, 10 = worst possible pain), administered every 15 minutes during the procedure. Patients verbally rated their pain by choosing a number between 0 and 10. The secondary outcomes were the occurrence of adverse effects and the need for a rescue dose of intravenous fentanyl (50 µg, if NRS > 8 or intolerable pain). The stone-free rate was assessed at 2–4 weeks.
Results: Baseline characteristics were comparable between groups, except for body mass index. The mean pain scores were 6.39 ± 1.26 in Group A, 5.38 ± 1.85 in Group B, and 5.88 ± 1.34 in Group C. Group B reported significantly lower pain scores than Group A at 15 minutes (2.5 ± 1.96 vs. 3.77 ± 1.95, p = 0.018) and 30 minutes (4.73 ± 2.24 vs. 6.08 ± 1.81, p = 0.016). Group C had significantly lower pain scores at 60 minutes (6.73 ± 1.59 vs. 7.88 ± 1.99, p = 0.034) and 75 minutes (7 ± 1.39 vs. 7.94 ± 1.3, p = 0.040) compared to Group A. The incidence of adverse effects was lowest in Group C (dizziness: 23.1%). A rescue intravenous fentanyl dose was required among 6 (23.1%) of Group A, 6 (23.1%) of Group B, and 11 (42.3%) of Group C; these differences were not statistically significant.
Conclusion: Combining oral and intravenous analgesics offers superior early pain control during ESWL compared to intravenous fentanyl alone. Oral-only multimodal analgesia, with provision for a rescue intravenous fentanyl dose, administered when needed, provided comparable pain relief with fewer side effects and may reduce routine opioid use during ESWL. The inclusion and reporting of the rescue dose are essential for a consistent and practical analgesic strategy.
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