The effect of esketamine combined with sufentanil based patient-controlled intravenous analgesia for postoperative pain in patients undergoing third molar surgery and maxillofacial trauma: a randomized clinical trial

Abstract

Abstract Purpose This study aims to investigate the effects of combining esketamine with sufentanil for postoperative patient-controlled intravenous analgesia (PCIA) in patients undergoing elective impacted tooth surgery or open reduction and internal fixation. Methods In this single-center, prospective, double-blinded, randomized, parallel-controlled trial, 91 patients were randomly divided into two groups. The experimental group (group ES, n = 46) received a combination of sufentanil 1.5 µg/kg and esketamine 1.0 mg/kg, while the control group (group S, n = 45) received sufentanil 2 µg/kg alone for PCIA after surgery. Primary outcome was assessed using the Visual Analogue Scale (VAS) for patients at rest and during mouth opening at 6 h, 12 h, 24 h, and 48 h post-surgery. Secondary outcomes included the Ramsay Sedation Scale (RSS) scores, the Quality of Recovery-15 (QoR-15) scores, patient satisfaction with analgesia, and the occurrence of adverse events within 48 h post-surgery. The frequency of PCIA button presses and the number of patients requiring rescue analgesia were also recorded. Results The resting VAS scores and the mouth-opening VAS scores at 6 h, 12 h, 24 h, and 48 h post-surgery were significantly lower in Group ES than in Group S (P < 0.05). Additionally, the RSS scores were significantly higher at 6 h (P = 0.032) and 12 h (P = 0.021) post-surgery in Group ES. The frequency of PCIA postoperative use within 48 h post-surgery decreased (P = 0.021) in Group ES, while satisfaction with analgesia and QoR-15 scores increased (P = 0.001 and P < 0.001, respectively). The incidences of postoperative dizziness and nausea/vomiting reduced (P = 0.045 and P = 0.036, respectively) in Group ES, but one adverse event of nightmare was observed. There was no significant difference in rescue analgesia between the two groups. Conclusion The use of esketamine combined with sufentanil in patients undergoing third molar surgery and maxillofacial trauma can alleviate short-term postoperative pain, and improve the quality of postoperative recovery. Esketamine is worth promoting in the clinical application of oral and maxillofacial surgery. Trial registration The study was retrospectively registered in chictr.org.cn with the identifier: ChiCTR2400086662 on 08/07/2024.

Keywords

• Esketamine
• Sufentanil
• Third molar surgery and maxillofacial trauma
• Postoperative Pain
• Patient-Controlled Intravenous Analgesia