A Multi-Center Evaluation of the Pharmacokinetics and Safety of Intravenous Ibuprofen in Infants 1-6 Months of Age.

BACKGROUND: Enteral ibuprofen was first approved as a prescription drug in 1974 for the US market. An intravenous (IV) ibuprofen formulation is approved for use in children older than 6 months of age, but there are limited studies specifically evaluating the pharmacokinetics and safety in children 1-6 months of age. AIMS: The primary purpose of this study was to evaluate the pharmacokinetics of IV ibuprofen in infants younger than 6 months of age. The secondary objective was to evaluate the safety of single and repeated doses of IV ibuprofen in infants younger than 6 months of age. METHODS: This was an industry-sponsored multi-center study. Institutional Review Board approval and informed parental consent were obtained prior to enrollment. Hospitalized neonates and infants younger than 6 months of age with fever or expected postoperative pain were eligible. Enrolled patients received 10 mg/kg of IV ibuprofen every 6 h, with up to four doses per day. Patients were randomized to two sparse sampling technique pharmacokinetic sample time groups. Group 1 samples were drawn at 0, 30 min, and 2 h, while group 2 samples were drawn at 0 min, 1, and 4 h after administration. RESULTS: A total of 24 children were enrolled in the study, with 15 male patients and 9 female patients. The median age of the cohort was 4.4 months (range 1.1-5.9 months), and the median weight was 5.9 kg (range 2.3-8.8 kg). The arithmetic mean and standard error for peak plasma ibuprofen concentration was 56.28 ± 2.77 µg/mL. Plasma levels declined rapidly with a mean elimination half-life of 1.30 h. Time to peak ibuprofen effect and concentration were similar when compared with older pediatric patients. Clearance and volume of distribution were also similar to those reported in older pediatric patients. No drug-related adverse events were reported. CONCLUSIONS: The pharmacokinetic and short-term safety profiles of IV ibuprofen in pediatric patients 1-6 months of age are comparable to those in children older than 6 months of age. TRIAL REGISTRATION: Clinicaltrials.gov Trial Registration number and date: NCT02583399-Registered July 2017.

Subcutaneous analgesic system versus epidural for post-operative pain control in surgical pediatric oncology patients.

BACKGROUND/PURPOSE: Pediatric oncology patients often undergo open operations for tumor resection, and epidural catheters are commonly utilized for pain control. Our purpose was to evaluate whether a subcutaneous analgesic system (SAS) provides equivalent post-operative pain control. METHODS: An IRB approved, retrospective chart review of children age <18 undergoing open abdominal, pelvic or thoracic surgery for tumor resection between 2017 and 2019 who received either epidural or SAS for post-operative pain control was performed. Comparisons of morphine milligram equivalents (MME), pain scores, and post-operative course were made using parametric and non-parametric analyses. RESULTS: Of 101 patients, median age was 7 years (2 months-17.9 years). There were 65 epidural and 36 SAS patients. Transverse laparotomy was the most common incision (41%), followed by thoracotomy (29%). Pain scores, MME, urinary catheter days, and post-operative length of stay (LOS) were similar between the two groups. Urinary catheter use was more common in epidural patients (70% vs 30%, p = <0.001). SAS patients had faster time to ambulation and time to regular diet by 1 day (p = 0.02). Epidural patients more commonly had a complication with the pain device (20% vs 3%, p = 0.02) and were more likely to be discharged with narcotics (60% vs. 40%, p = 0.04). Charges associated with the hospital stay were similar between the two groups. CONCLUSION: In pediatric oncology patients undergoing open abdominal, pelvic, and thoracic surgery, SAS may provide similar pain control to epidural, but with faster post-operative recovery, fewer complications, and less discharge narcotic use. A prospective study is needed to validate these results. TYPE OF STUDY: Retrospective Comparative LEVEL OF EVIDENCE: Level III.

Real-Time Ultrasound Improves Accuracy of Caudal Block in Children.

BACKGROUND: Caudal block, the most common regional anesthetic in children, is predominantly performed using palpation to determine placement. The efficacy of the palpation technique is unknown with respect to block success. While ultrasound has been suggested for use during caudal block, its use is infrequent. METHODS: A single-blinded prospective observational trial was performed evaluating provider success rate of caudal blocks placed by palpation alone. After needle insertion and partial local anesthetic injection, an ultrasound was performed to confirm correct location. RESULTS: A total of 109 caudal blocks were performed during the prospective observational study. Success rate for caudal blocks done by palpation alone was 78.9% as confirmed by ultrasound. In 21.1% of caudal blocks, the provider incorrectly judged the needle to be in the caudal space as confirmed with ultrasound. CONCLUSIONS: Real-time ultrasound visualization of local anesthetic injection provides reliable and immediate confirmation during caudal block in children.

Erector Spinae Plane Catheter for Postoperative Analgesia After Thoracotomy in a Pediatric Patient: A Case Report.

Thoracotomy is associated with significant postoperative pain. While postoperative pain control after thoracotomy is most commonly managed with a thoracic epidural or paravertebral catheter, both are fraught with significant risks and are technically challenging to perform in pediatric patients. The erector spinae plane block is a relatively novel, easy-to-perform block used to provide thoracic wall analgesia. We present a case of a pediatric patient undergoing thoracotomy whose postoperative pain was managed with an erector spinae plane catheter.

Chronic obstructive pulmonary disease and cardiac comorbidities: A cross-sectional study.

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is a global health issue with cigarette smoking being an important risk factor. COPD affects pulmonary blood vessels, right ventricle, as well as left ventricle leading to the development of pulmonary hypertension (PH), cor-pulmonale (COR-P), right and left ventricular dysfunction. Echocardiography provides a rapid, noninvasive, portable, and accurate method to evaluate cardiac functions. Early diagnoses and intervention for cardiac comorbidities would reduce mortalities. MATERIALS AND METHODS: A cross-sectional study. Total 50 patients of moderate to severe COPD according to GOLD guidelines were taken from Department of Respiratory Medicine, Smt. B. K. Shah Medical Institute and Research Centre, Vadodara. All patients underwent investigations such as chest X-ray PA view, ECG, and spirometry followed by two-dimensional echocardiography. RESULTS: We investigated 49 males and 1 female patients ranging from 35 to 80 years of age. Twenty-nine individuals were of moderate COPD and twenty-one of severe COPD. Of these cases 29 had left ventricular diastolic dysfunction (LVDD) changes, 24 were diagnosed with PH and 16 had changes of COR-P. The study showed the linear relation between the severity of LVDD, PH, and COR-P with the severity of COPD. CONCLUSION: Our study put emphasis on early cardiac screening of all COPD patients which will be helpful in the assessment of the prognosis and will further assist in identifying the individuals likely to suffer increase morbidity and mortality.