Oral Pregabalin versus Oral Midazolam as Sedative Premedication for Pediatric Tonsillectomy: A Randomized Controlled Trial

Background: Premedication in pediatric cases plays a critical role in achieving anxiolysis, which facilitates a smoother separation from parents and simplifies the induction of anesthesia. This research assessed the efficacy of pregabalin as a premedication agent in pediatric anesthesia relative to the commonly used midazolam. Methods: This randomized, double-blind controlled study involved 90 children aged 1 to 7 years undergoing tonsillectomy. Participants were randomly allocated into three equal groups receiving pregabalin syrup at 3.5 mg/kg (Group P), midazolam at 0.5 mg/kg (Group M), or a placebo solution (Group C). The primary outcome was assessed using the postoperative pediatric agitation scale (Watcha), while secondary outcomes included parental separation anxiety, acceptance of the anesthesia mask, FLACC (Face, Legs, Activity, Cry, Consolability) pain scores, and extubation time. Results: Postoperative Watcha scale were significantly reduced in Groups P and M in comparison with the controls (p<0.05), with scores in the two intervention groups being similar. Groups P and M demonstrated significantly improved parental separation anxiety and mask acceptance relative to controls. The intervention groups exhibited significantly diminished FLACC scores at the post-anesthesia care unit (PACU) and at 2, 4, and 6h postoperatively. Extubation time following cessation of general anesthesia was significantly prolonged in group M as opposed to both P and control groups (p<0.001). Conclusions: Pregabalin and midazolam showed similar effects on emergency agitation, parental separation anxiety, mask acceptance, and time of first analgesia requirements. However, pregabalin demonstrated greater efficacy in postoperative pain reduction and didn’t prolong the extubation time in comparison to midazolam.