Perioperative Gabapentin in Pediatric Thoracic Surgery Patients-Randomized, Placebo-Controlled, Phase 4 Trial.

Abstract

OBJECTIVE\nTo determine whether the use of perioperative gabapentin reduces postoperative pain and anxiety, decreases ropivacaine consumption and side effects, and improves patient satisfaction.\n\n\nDESIGN\nRandomized, placebo-controlled, phase 4 trial.\n\n\nBLINDING\nParticipants, care providers, investigators, data analysts.\n\n\nSETTING\nDepartment of Thoracic Surgery of the Institute of Tuberculosis and Lung Disease, Rabka Zdrój Branch, Poland.\n\n\nSUBJECTS\nForty patients undergoing the Ravitch procedure.\n\n\nMETHODS\nPatients aged nine to 17\u2009years were randomized into a gabapentin (preoperative 15\u2009mg/kg, treatment) or placebo group. Postoperative analgesia included gabapentin (7.5\u2009mg/kg) or placebo two times per day for three days, epidural ropivacaine + fentanyl, paracetamol, nonsteroidal anti-inflammatory drugs, and metamizol as a rescue drug. Pain, anxiety, analgesic consumption, side effects, and patient satisfaction were recorded.\n\n\nRESULTS\nThere was no statistically significant difference in median pain scores (numerical rating scale < 1/10) or incidence of adverse side effects between the gabapentin group (N\u2009=\u200920) and the placebo group (N\u2009=\u200920). Postoperative anxiety scores were significantly lower than before surgery in the gabapentin group (6 [4-8] vs 7 [6-8.5], P < 0.01) and remained unchanged in the placebo group (6 [5-6.5] vs 6 [5-7], P = 0.07). Gabapentin-treated patients received a lower number of doses of ondansetron when compared with the placebo group (6 [5-6] vs 7 [6-9], P = 0.02). A significant negative association was found between patient satisfaction and postoperative state anxiety in the gabapentin group (R = -0.51, P = 0.02).\n\n\nCONCLUSIONS\nPerioperative administration of gabapentin resulted in a decrease of postoperative anxiety in pediatric patients undergoing the Ravitch procedure.