Perioperative gabapentin in pediatric thoracic surgery patients-randomized, placebo-controlled, phase 4 trial

Abstract

Objective. To determine whether the use of perioperative gabapentin reduces postoperative pain and anxiety, decreases ropivacaine consumption and side effects, and improves patient satisfaction. Design. Randomized, placebo-controlled, phase 4 trial. Blinding. Participants, care providers, investigators, data analysts. Setting. Department of Thoracic Surgery of the Institute of Tuberculosis and Lung Disease, Rabka Zdroj Branch, Poland. Subjects. Forty patients undergoing the Ravitch procedure. Methods. Patients aged nine to 17 years were randomized into a gabapentin (preoperative 15 mg/kg, treatment) or placebo group. Postoperative analgesia included gabapentin (7.5 mg/kg) or placebo two times per day for three days, epidural ropivacaine þ fentanyl, paracetamol, nonsteroidal anti-inflammatory drugs, and metamizol as a “rescue drug.” Pain, anxiety, analgesic consumption, side effects, and patient satisfaction were recorded. Results. There 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 ¼ 20) and the placebo group (N ¼ 20). 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 ¼ 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 ¼ 0.02). A significant negative association was found between patient satisfaction and postoperative state anxiety in the gabapentin group (R ¼ -0.51, P ¼ 0.02). Conclusions. Perioperative administration of gabapentin resulted in a decrease of postoperative anxiety in pediatric patients undergoing the Ravitch procedure.