Abstract
BACKGROUND: Tramadol is widely employed as part of multimodal perioperative analgesia protocols. Despite its extensive clinical use, no existing literature has specifically investigated the effect of intravenous tramadol on postoperative sore throat (POST) following endotracheal intubation. To address this knowledge gap, we conducted a clinical study evaluating the efficacy of intravenous tramadol in reducing the incidence of POST among patients undergoing tracheal intubation for thyroid surgery. METHODS: We randomized 171 American Society of Anesthesiologists (ASA) physical status I-II female patients scheduled for thyroidectomy into three groups: Control: Standard care without tramadol; Pre-tramadol: Received intravenous tramadol (1 mg/kg) 15 min preoperatively; Post-tramadol: Received intravenous tramadol (1 mg/kg) at the initiation of surgical wound irrigation. The primary outcome was the incidence of POST at 24 h after extubation. Secondary outcomes included the incidence of POST in the post-anesthesia care unit (PACU) and at 4 h after extubation. RESULTS: The incidence of POST at rest was 7.1% for Control group, 7.0% for Pre-tramadol group and 1.8% for Post-tramadol group at rest (p = 0.342) at 24 h after extubation; The incidence of POST on movement were 48.2%, 63.2% and 49.1% (p = 0.201) at 24 h after extubation, respectively. Similar results also appeared at PACU and 4 h after extubation. CONCLUSIONS: Intravenous tramadol (1 mg/kg) did not significantly reduce the incidence of POST following tracheal intubation in patients undergoing scheduled thyroidectomy. TRIAL REGISTRATION: Date of registration: 05/08/2021. ClinicalTrials.gov; Identifer: NCT04991493. URL: https://clinicaltrials.gov/study/NCT04991493.