The Effects of Gabapentin on Post-Operative Pain and Anxiety, Morphine Consumption and Patient Satisfaction in Paediatric Patients Following the Ravitch Procedure-A Randomised, Double-Blind, Placebo-Controlled, Phase 4 Trial.

The aim of the study was to investigate whether the use of pre- and postoperative gabapentin can decrease postoperative pain, morphine consumption, anxiety and side effects, as well as improve patient satisfaction. A total of 56 patients, 9−17 years of age, undergoing a modified Ravitch procedure, were randomised (allocation ratio 1:1) to receive multiple perioperative doses of gabapentin (preoperatively 15 mg/kg, postoperatively 7.5 mg/kg, two times per day for three days) or a placebo. All the patients received intravenous infusion of morphine, paracetamol and non-steroidal anti-inflammatory drugs. Metamizole was given as a "rescue drug". The observation period included the day of surgery and three postoperative days. The primary outcomes were postoperative pain intensity (at rest, during deep breathing and coughing). Additional outcomes included the consumption of morphine, the total number of doses of metamizole, anxiety, postoperative side effects and patient satisfaction. Median average and maximal pain scores (on the day of surgery and on the second postoperative day) were significantly lower only in the gabapentin group at rest (p < 0.05). Compared to the placebo group, gabapentin treatment reduced the demand for morphine on the first postoperative day (median 0.016 vs. 0.019 mg/kg/h; p = 0.03) and the total number of metamizole doses (median 1 vs. 2 p = 0.04). Patient satisfaction was significantly greater in the gabapentin group (median 10 vs. 9; p = 0.018). Anxiety and postoperative side effects were similar in both groups (p > 0.05). Pre- and postoperative gabapentin administration as part of a multimodal analgesic regimen may decrease postoperative pain, opioid consumption and demand for a "rescue drug", as well as improve patient satisfaction.

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

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.

Ropivacaine/Fentanyl vs. Bupivacaine/Fentanyl for Pain Control in Children after Thoracic Surgery: A Randomized Study.

BACKGROUND: Although bupivacaine remains a standard local anesthetic for postoperative epidural infusions in pediatric patients, it is increasingly being replaced with ropivacaine by many anesthesiologists. Ropivacaine is associated with less risk for cardiac and central nervous system toxicity. AIMS: The purpose of this study was to compare analgesic efficacy and adverse events of postoperative epidural analgesia with ropivacaine/fentanyl versus bupivacaine/fentanyl in children after the Ravitch procedure and thoracotomy. DESIGN: This was a prospective randomized controlled study. SETTINGS: This study was conducted at the Department of Thoracic Surgery of the Institute of Tuberculosis and Lung Diseases in Rabka Zdroj, Poland. PARTICIPANTS/SUBJECTS: 94 patients undergoing elective thoracic surgery. METHODS: Patients aged 7-17 years were randomly allocated into a ropivacaine 0.2% (RF, n = 45) or bupivacaine 0.125% (BF, n = 45) group; 1 mL of each analgesic solution contained 5 µg fentanyl. All patients received acetaminophen and nonsteroidal anti-inflammatory drugs. Nurses assessed pain intensity and incidence of adverse events over 72 hours after surgery and modified analgesia if patient pain intensity was greater than 2 out of 10. RESULTS: There was no statistically significant difference in median pain scores and incidence of adverse events between the RF group and the BF group. The analgesia was excellent (median pain intensity scores at rest, during deep breathing, and when coughing was less than 1 out of 10 in all patients). Adverse events included incidents of desaturation (64/90), nausea (18/90), vomiting (31/90), pruritus (12/90), urinary retention (2/90), paresthesia (11/90), anisocoria (2/90), and Horner syndrome (2/90). CONCLUSIONS: Thoracic epidural analgesia using an RF and BF solution resulted in similar pain relief and adverse event profiles.

Comparative efficacy of continuous infusion of bupivacaine/fentanyl and ropivacaine/fentanyl for paediatric pain control after the Ravitch procedure and thoracotomy. A prospective randomized study.

AIMS: (1) To compare the efficacy of bupivacaine/fentanyl and ropivacaine/fentanyl for postoperative pain control (2). To identify the predictors of acute post-operative pain at rest, during deep breathing and coughing. METHODS: The study was performed in patients aged 6-18 years after thoracic surgery. The subjects were randomized to the bupivacaine 0.125%/fentanyl 5.0 µg/mL (n=46) or ropivacaine 0.2%/fentanyl 5.0 µg/mL (n=48) group; analgesic mixtures were administered through epidural catheter. All the patients received paracetamol and non-steroidal anti-inflammatory drugs. The observation period after surgery lasted 72 h. Pain intensity was assessed at rest, during deep breathing and coughing and was based on the Numerical Rating Scale and the FLACC scale (range 0-10). If the pain was above 2/10, the analgesia was modified. RESULTS: Median pain scores at rest (0.4 vs. 0.5), during deep breathing (0.3 vs. 0.3) and coughing (0.6 vs. 0.6) were comparable in BF and RF group. The intensity of pain at rest was associated with the number of drains inserted into the thorax (ß=0.39), the number of pain intensity measurements (ß=0.36) and the number of nursing interventions undertaken to relieve pain (ß=0.16). Pain intensity at rest determined the intensity of pain during deep breathing (ß=0.60), which in turn decided on the severity of pain during coughing (ß=0.80). The intensity of pain was increased by age. CONCLUSIONS: Thoracic epidural bupivacaine/fentanyl provided adequate pain relief and similar analgesia to ropivacaine/fentanyl. The effectiveness of analgesia depended on the number of pain measurements and interventions by nurses to relieve the pain. TRIAL REGISTRATION: ClinicalTrials.gov; Multimodal Analgesia in Children and Adolescents After the Ravitch Procedure and Thoracotomy; NCT03444636; https://clinicaltrials.gov/ct2/show/NCT03444636.