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 Zdrój 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 + 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 = 20) and the placebo group (N = 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 = 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).

Conclusions: Perioperative administration of gabapentin resulted in a decrease of postoperative anxiety in pediatric patients undergoing the Ravitch procedure.

Trial registration: ClinicalTrials.gov NCT03393702.

Keywords: Anxiety; Gabapentin; Pain; Patient Satisfaction; Placebo; Ravitch Procedure.