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.

[Terminology concerning intravenous ports]. / Próba usystematyzowania terminologii dotyczacej portów dozylnych.

Ports are more and more often applied with patients requiring the permanent intravenous access, not only in the cancer treatment. Very devices, as well as procedures associated with applying them are determined in the heterogeneous way. Therefore during the last conference "Intravenous Port--implantation, care, complications" an attempt to systematize the applied terminology was made.

Maximum Pain at Rest in Pediatric Patients Undergoing Elective Thoracic Surgery and the Predictors of Moderate-to-Severe Pain-Secondary Data Analysis.

INTRODUCTION: Pain management among children following thoracic surgery is an area of significant practice variability. Understanding the risk factors of moderate-to-severe pain intensity will allow for adequate pain relief. The aim of the study was to assess the maximum intensity of pain at rest in pediatric patients within 24 h of thoracic surgery and to investigate the prevalence and predictors of moderate-to-severe pain. METHODS AND FINDINGS: This is a prospective cohort study of patients in observational and randomized controlled trials following thoracic surgery. A secondary analysis of data was conducted using data collected from 446 patients aged 7-18 years undergoing thoracic surgery. The primary endpoint was maximum pain intensity (Numerical Rating Scale; NRS; range: 0-10) and the secondary endpoint was the prevalence and predictors of moderate-to-severe pain (NRS > 2/10). The median maximum pain in the cohort was 3 [0; 4]. During the immediate postoperative period, 54% of patients reported a maximum NRS > 2/10. The infusion of morphine by an intravenous route (vs. epidural route) was a protective factor against moderate-to-severe pain. Taking into account the findings related to the type of epidural analgesia (vs. intravenous morphine), it was found that only the administration of 0.25% bupivacaine combined with morphine or fentanyl was a protective factor against moderate-to-severe postoperative pain. Patients aged 14-18 years (vs. aged 7-13 years) had an increased risk of reporting pain as moderate-to-severe. CONCLUSIONS: The route of analgesic administration, type of multimodal analgesia, and patients' age predict moderate-to-severe pain in pediatric patients after thoracic surgery.

Factors Related to Anxiety in Paediatric Patients and Their Parents before and after a Modified Ravitch Procedure-A Single-Centre Cohort Study.

OBJECTIVE: To assess the factors related to perioperative state anxiety in paediatric patients and their parents. METHODS: A cohort study was conducted on paediatric patients 9-17 years of age, who underwent the modified Ravitch procedure (n = 96), and their parents (n = 96). The level of anxiety was measured using the State-Trait Anxiety Inventory questionnaire. Multivariable linear regression models were calculated to find the relationships between the pre- and postoperative state anxiety of the patients/parents and the independent variables, both demographic (age, gender) and clinical (e.g., postoperative pain, trait anxiety). RESULTS: Preoperative anxiety in the paediatric patients was positively correlated with their trait anxiety (ß = 0.47; 95% CI: 0.29 to 0.64) and preoperative parental anxiety (ß = 0.24; 95% CI: 0.07 to 0.42). The high level of preoperative anxiety (vs. low and moderate) (ß = 0.40; 95% CI: 0.22 to 0.58), trait anxiety (ß = 0.22; 95% CI: 0.04 to 0.40) and average postoperative pain at rest (ß = 0.18; 95% CI: 0.01 to 0.34) had a positive impact on the postoperative anxiety in patients. However, the patients' age was negatively correlated with postoperative anxiety (ß = -0.19; 95% CI: -0.35 to -0.02). Three variables were found to predict preoperative parental anxiety: their trait anxiety (ß = 0.41; 95% CI: 0.23 to 0.59), female gender (ß = 0.18; 95% CI: 0.002 to 0.36) and the intravenous route for the postoperative pain management in the patients (ß = -0.18; 95% CI: -0.36 to -0.001). The parental postoperative anxiety was influenced by their trait anxiety (ß = 0.24; 95% CI: 0.04 to 0.43), preoperative anxiety in patients (ß = 0.21; 95% CI: 0.02 to 0.40) and female gender of children (ß = 0.19; 95% CI: 0.001 to 0.39). CONCLUSIONS: Trait anxiety was a strong factor positively affecting the perioperative state anxiety. In addition, paediatric patient anxiety before surgery was related to their parents' anxiety, and, after surgery, this was associated with high preoperative anxiety, pain and age. The parents' anxiety before surgery was influenced by gender and the type of postoperative analgesia in the patients, while, after surgery, this was influenced by the patients' preoperative anxiety/gender.

Intravenous Morphine Infusion versus Thoracic Epidural Infusion of Ropivacaine with Fentanyl after the Ravitch Procedure-A Single-Center Cohort Study.

OBJECTIVE: To compare the efficacy of analgesia with intravenous infusion of morphine and thoracic epidural infusion of ropivacaine with fentanyl in pediatric patients after the Ravitch procedure. METHODS: Postoperative analgesia was achieved by intravenous morphine infusion with a dose of 0.02-0.06 mg/kg per hour (intravenous group, n = 56) or thoracic epidural infusion of 0.2% ropivacaine and fentanyl 5 µg/mL with a flow rate of 0.1 mL/kg per hour (epidural group, n = 40). Furthermore, the multimodal pain management protocol included paracetamol, non-steroidal anti-inflammatory drugs, and metamizole as a rescue drug. The primary outcomes included pain scores (according to the Numerical Rating Scale, range 0-10), while the secondary outcomes included consumption of the rescue drug, anxiety, postoperative side effects, and patient satisfaction. The observation period lasted from postoperative day 0 to postoperative day 3. RESULTS: Median average and maximal pain scores at rest, during deep breathing, and coughing were significantly lower in the intravenous group compared to the epidural group (p < 0.05). The effect size was medium (Cohen's d ranged from 0.5 to 0.7). Patients receiving morphine required significantly lower numbers of metamizole doses than in the epidural group (median 1 vs. 3; p = 0.003; Cohen's d = 0.6). Anxiety, postoperative side effects, and patient satisfaction were similar in both groups (p > 0.05). CONCLUSIONS: An intravenous infusion of morphine may offer better postoperative analgesia than a thoracic epidural infusion of ropivacaine with fentanyl.

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.

Influence of preoperative information support on anxiety, pain and satisfaction with postoperative analgesia in children and adolescents after thoracic surgery: A randomized double blind study.

AIMS/BACKGROUND: The proportion of patients who experience anxiety prior to planned surgery, even a minimally invasive one, is estimated at 50-70%. Thoracic surgery, causes significant preoperative anxiety, especially in children. The aim of this study was to determine the effect of an important component of psychological preparation for a surgery as information support on levels of anxiety, pain and satisfaction with postoperative analgesia. METHODS: The randomized double blind study including patients aged 9-18 years qualified for lateral thoracotomy or Ravitch procedure. The subjects were randomized to the control group (n=56) provided with a routine preoperative information by a nurse, and the experimental group (n=56) offered additional psychological consultation. Data were collected via the State-Trait Anxiety Inventory. RESULTS: In the experimental group, the level of state anxiety at 48 h post-surgery was significantly lower than prior to the procedure, but only in subjects with preoperative trait anxiety Conclusion: Information support from a psychologist offered prior to a thoracic surgery decrease the level of postoperative state anxiety solely in children with lower levels of trait anxiety. Higher level of postoperative state anxiety negatively affect patients' satisfaction with post-surgical analgesia. TRIAL REGISTRATION: ClinicalTrials.gov; Influence of Preoperative Support on Anxiety, Pain and Satisfaction With Postoperative Analgesia; NCT03488459, https://clinicaltrials.gov/ct2/show/record/NCT03488459?cntry=PL&city=Rabka-Zdr%C3%B3j&rank=1.

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.

[The use of activated recombinant factor VII in the treatment of nasopharyngeal hemorrhage in a patient with extensive fronto-basal injuries. Case report]. / Zastosowanie rekombinowanego aktywowanego czynnika VII w leczeniu krwotoku z czesci nosowej gardla u chorego z rozleglym urazem czolowo-podstawnym. Opis Przypadku.

The main indication for recombinant activated factor VII (rFVIIa) is the treatment of patients with hemophilia or other hemostatic disturbances. Additionally, rFVIIa has been considered as a universal hemostatic agent prompting its use in the management of severe uncontrolled bleeding in patients without pre-existing coagulopathies. Authors report their own experience in the beneficial effect of rFVIIa (NovoSeven, NovoNordisk, Denmark) administration in a patient with severe bleeding from the nasopharyngeal region after extensive fronto-basal injuries. After one dose of NovoSeven (2.4 mg - 40 microg/kg of body weight) reduction in bleeding, normalization of hemostasis parameters and hemodynamic stabilization of the patient were achieved.