Intravenous Paracetamol for Perioperative Shivering Prophylaxis in Patients Undergoing Spinal Anesthesia: A Prospective, Randomized, Double-Blind Controlled Trial.
Ruenhunsa Thitinuch T, Nonphiaraj Saranyoo S, Srikajonkiat Donlaya D, Panichakul Kanya K et al.
Perioperative shivering (POS) is a common, distressing complication of spinal anesthesia (SA), but a standard prevention has not been identified. This study aimed to determine whether intravenous (IV) paracetamol prevents POS in patients undergoing surgery under SA. In this prospective, randomized, double-blind controlled trial, 92 patients scheduled for surgery under SA received IV paracetamol 15 mg/kg (n = 46) or an equal volume of saline (n = 46) over 15 min before SA. The primary outcome was the overall incidence of POS. The primary analysis was per-protocol (PP) (n = 86; paracetamol 42; control 44) after exclusion of 6 patients postrandomization. Post hoc best-case and worst-case sensitivity analyses including all 92 patients were also performed. Secondary outcomes included shivering score, shivering duration, rescue pethidine requirements, temperature changes, and adverse events. Baseline and intraoperative characteristics were comparable between groups. In the PP analysis, POS incidence was lower with paracetamol than control (26.2% vs. 50.0%; p = 0.023). This was not robust to missing-data assumptions: the best-case analysis remained significant (23.9% vs. 52.2%; p = 0.005), but the worst-case analysis did not (32.6% vs. 47.8%; p = 0.137), and the fragility index was 2. Intraoperative shivering occurred in 4.8% vs. 22.7% (p = 0.016). Paracetamol also demonstrated lower highest shivering score (p = 0.039), shorter duration of shivering (p = 0.031), and less rescue pethidine use (p = 0.019). There were no statistically significant differences in temperature changes, hypothermia, or nausea and vomiting between groups. In the PP analysis, prophylactic IV paracetamol was associated with a lower incidence, severity, and duration of POS and a lower need for rescue pethidine use. However, the primary finding was not robust under worst-case assumptions (fragility index 2); larger confirmatory trials are warranted. Trial Registration: Thai Clinical Trials Registry: TCTR20210209004.