Continuous infusion versus intermittent bolus doses of fentanyl for analgesia and sedation in neonates: an open-label randomised controlled trial.

OBJECTIVE: Adequate data on fentanyl pharmacokinetics in neonates are lacking. The study was performed to compare serum concentrations and clinical outcome between continuous infusion (CI) and intermittent bolus (IB) doses of fentanyl for analgesia and sedation in neonates. METHODS: In this open-label randomised controlled trial, neonates requiring 24-48 hours of mechanical ventilation and fentanyl administration were recruited. In CI regimen, 1 mcg/kg loading dose was followed by 1 mcg/kg/hour infusion. In IB regimen, 1mcg/kg/dose was administered every 4 hours.Maximum six blood samples were collected in 48 hours from each baby at prespecified time points for estimating serum fentanyl concentration. Secondary outcomes were pain scores (Neonatal Infant Pain Scale and Neonatal Pain, Agitation and Sedation Scale for acute and ongoing pain, respectively) and incidence of adverse effects of fentanyl. RESULTS: 100 neonates were recruited, 53 in CI and 47 in IB group. In CI regimen, median (IQR) serum fentanyl concentration was 0.42 (0.35, 0.46) to 0.61 (0.47, 0.89) ng/mL throughout the infusion period. In IB regimen, median (IQR) peak concentration ranged from 2.21 (1.82, 3.55) to 3.61 (2.91, 4.51) ng/mL and trough concentration 0.41 (0.33, 0.48) to 0.97 (0.56, 1.25) ng/mL for various doses.Median (IQR) peak concentration (Cmax, 3.06 (1.09, 4.50) vs 0.78 (0.49, 1.73) ng/mL; p<0.001) was significantly higher and area under concentration-time curve (AUC0-24, 19.6 (10.4, 33.5) vs 13.2 (10.8, 22.6) µg·hour/L; p=0.12) was higher (though not statistically significant) in IB than CI regimen. Pain scores and adverse effects were comparable between the two regimens. CONCLUSION: CI regimen of fentanyl produces steady serum concentrations, whereas IB regimen produces wide fluctuations in serum concentration with high-peak concentrations. A serum fentanyl concentration of 0.4-0.6 ng/mL produces adequate analgesia and sedation in neonates. TRIAL REGISTRATION NUMBER: CTRI/2014/11/005190.

Standard care with plastic bag or portable thermal nest to prevent hypothermia at birth: a three-armed randomized controlled trial.

OBJECTIVE: To assess the efficacy of adding plastic bag or portable thermal nest (PTN) to standard care in preventing hypothermia soon after birth in 1500-2499 g infants. METHODS: Infants were randomized into standard thermal care alone, plastic bag with standard care or PTN with standard care. Axillary temperature was measured at admission and every 30 min till euthermia. All babies were followed-up till day 7. RESULTS: We recruited 300 infants: plastic bag (101), PTN (99) and standard care group (100). Admission temperature was 36.4 °C (0.52) in plastic bag group, 36.3 °C (0.50) in PTN and 36.1 °C (0.59) in standard care group (p < 0.001). Incidence of hypothermia was lowest in plastic bag group (44.6%), followed by PTN (60%) and standard care (67%). Secondary outcomes were comparable. CONCLUSION: Addition of plastic bag or PTN to standard care significantly reduces incidence and duration of hypothermia soon after birth. Plastic bag is more effective than PTN.

Comparison of Two Low-cost Methods of Cooling Neonates with Hypoxic Ischemic Encephalopathy.

Background: Several low-cost methods are used in resource-limited settings to provide therapeutic hypothermia in asphyxiated neonates. There is inadequate data about their efficacy and safety. This is a retrospective study comparing two low-cost cooling methods-frozen gel packs (FGP) and phase changing material (PCM). Results: There were 23 babies in FGP and 45 babies in the PCM group. Induction time was significantly shorter with FGP than PCM (45 vs. 90 minutes; p -value < 0.001). Proportion of temperature readings outside the target range was significantly higher (9.8% vs. 3.8%; p -value < 0.001) and fluctuation of core body temperature was wider (standard deviation of target temperature 0.4 °C vs. 0.28 °C) in the FGP group, compared with PCM group. Conclusion: Both FGP and PCM are effective and safe, comparable with standard servo-controlled cooling equipment. PCM has the advantage of better maintenance of target temperature with less nursing input, when compared with FGP.

Advantages of being diligent: lessons learnt from umbilical venous catheterisation in neonates.

Umbilical venous catheters (UVCs) are commonly used in neonatal units. Abdominal radiograph, taken soon after the insertion, is used to confirm the correct placement of the catheter. However, as demonstrated by our case series, complacency when an initial UVC is normally positioned can lead to detecting UVC-related complications very late. We describe cases of three neonates where, despite the initial UVC being confirmed to be well positioned, the patients developed life-threatening complications, including liver haematoma, left atrial thrombus and pericardial effusion causing cardiac tamponade. The routine use of point of care echocardiography helped in the early diagnosis of these complications. We suggest repeated echocardiographic screening at regular intervals in all newborn babies requiring UVCs, to ensure that the catheter is maintained in the proper position and for the early detection of catheter-related complications.

Pleural effusion caused by a malpositioned umbilical venous catheter in a neonate.

Umbilical venous catheterisation (UVC) insertion is a common procedure performed in most neonatal units. We report a case of a neonate who developed pleural and pericardial effusions and ascites due to a malpositioned UVC causing diaphragmatic perforation. Timely diagnosis using bedside sonography and prompt removal of the catheter resulted in resolution of the effusions without undue complications.