Effect of pregabalin versus midazolam premedication on the anesthetic and analgesic requirements in pediatric day-case surgery: A randomized controlled trial

Abstract

ABSTRACT Background: This study aimed to compare pregabalin and midazolam premedication in pediatric day-case surgery regarding anesthetic and analgesic requirements.Methods: Sixty patients scheduled for day-case surgery were randomly premedicated orally with either pregabalin (Group P) or midazolam (Group M). Intraoperative anesthetic and analgesic requirements were assessed as primary outcomes. Modified Ramsay Sedation Score (RSS), hemodynamic variables, time to eye opening and time to extubation after discontinuation of general anesthesia were measured. Post-anesthesia care unit (PACU) duration of stay, postoperative Pediatric Anesthesia Emergence Delirium (PAED) scale, and Faces Legs Activity Cry Consolability (FLACC) scale, and post-operative analgesic requirements were assessed as secondary outcomes. The study was pre-registered at the Pan African Clinical Trials Registry (registration number: PACTR201907535888819; date of registration: 22/07/2019).Results: We found no significant differences between the studied groups regarding types and duration of surgery, preoperative modified RSS, and postoperative PAED. The mean ranks of sevoflurane and fentanyl consumptions were significantly lower in group P (p < 0.001). Patients in group P showed significantly lower means of heart rate and arterial blood pressure after induction of anesthesia. Postoperative FLACC pain score showed a significantly lower mean rank in group P. The need for rescue analgesics and the mean ranks of rectal diclofenac and meperidine consumption was significantly lower in group P (p < 0.001). The mean ranks of total paracetamol doses were comparable in both groups (p = 0.090). Group P showed a significantly lower duration of stay in PACU and time to open the eye and to extubate, but significantly higher time to first analgesic requirement.Conclusion: Pregabalin significantly reduced the perioperative anesthetic and analgesic requirements, the PACU duration of stay, and the time to open the eye and to extubate, in comparison to midazolam; therefore, its use as a premedication in pediatric day-case surgery is recommended.