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Perioperative Gabapentin in Pediatric Thoracic Surgery Patients-Randomized, Placebo-Controlled, Phase 4 Trial
Lucyna Tomaszek1, Dariusz Fenikowski1, Piotr Maciejewski1
1Department of Thoracic Surgery, Institute of Tuberculosis and Lung Diseases, Rabka-Zdrój Branch, Rabka-Zdrój, Poland.
Insights
Perioperative gabapentin did not significantly reduce pain or side effects in pediatric patients undergoing the Ravitch procedure. However, it did lower postoperative anxiety and decrease the need for antiemetic medication.
Area of Science:
- Pediatric surgery
- Anesthesiology
- Pharmacology
Background:
- The Ravitch procedure is a surgical intervention for pectus deformities.
- Effective pain management and anxiety reduction are crucial for pediatric surgical recovery.
- Gabapentin is an anticonvulsant with potential analgesic and anxiolytic properties.
Purpose of the Study:
- To evaluate the efficacy of perioperative gabapentin in reducing postoperative pain and anxiety.
- To assess the impact of gabapentin on ropivacaine consumption and side effects.
- To determine if gabapentin improves patient satisfaction in pediatric patients undergoing the Ravitch procedure.
Main Methods:
- A randomized, placebo-controlled, phase 4 trial was conducted with 40 pediatric patients (9-17 years) undergoing the Ravitch procedure.
- Patients received either gabapentin (preoperative and postoperative) or a placebo.
- Pain, anxiety, analgesic use, side effects, and patient satisfaction were recorded.
Main Results:
- No significant difference in pain scores or adverse side effects was observed between the gabapentin and placebo groups.
- Postoperative anxiety scores were significantly lower in the gabapentin group compared to the placebo group.
- Gabapentin-treated patients required fewer doses of ondansetron (antiemetic).
Conclusions:
- Perioperative gabapentin administration effectively decreased postoperative anxiety in pediatric patients undergoing the Ravitch procedure.
- Gabapentin did not significantly impact pain scores or reduce the incidence of adverse effects.
- A negative association was noted between patient satisfaction and postoperative anxiety in the gabapentin group.
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.
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