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BACKGROUND: Gastric tube insertion is necessary to support early enteral feeding of newborns during their neonatal intensive care stay. This frequent and invasive procedure is known to be painful. Very few analgesic techniques (sweet solutions, sucking, swaddling, and skin-to-skin contact) are available to reduce the pain caused by orogastric tube insertion procedure. OBJECTIVE: To determine whether a new orogastric tube insertion technique modifies the pain response in newborns, we hypothesize that inserting an orogastric tube through the nipple of a bottle reduces pain caused by this procedure. DESIGN: Prospective, controlled, randomized, multicentered and open label study. SETTINGS: Three neonatal intensive care units in France (2 level 3 units and 1 level 2B). PARTICIPANTS: Full-term or premature newborns at 32 weeks of gestation or more, postnatal age between 48 hours and 21 days, not ventilated and requiring enteral feeding, were randomized into 2 groups: usual technique (n = 36) and experimental technique (n = 35). METHODS: Our experimental technique was to insert the orogastric tube through a modified nipple of a bottle. This method was compared with the usual technique of inserting the tube directly into the newborn's mouth without a support to guide it accompanied by a nipple encouraging sucking with a nonnutritive solution. An association of nonnutritive sucking and orally administered 30% glucose was given to all children for analgesic purposes. Pain during the orogastric tube insertion was assessed on video recordings by 2 independent experts, using a heteroassessment behavioral scale for pain (DAN-Douleur Aiguë du Nouveau-né; APN-Acute Pain in Newborns). The primary outcome was an Acute Pain in Newborns score of less than 3 at the time of the procedure. Comparisons were made using Fisher exact test or Mann-Whitney U test. Factors associated with an Acute Pain in Newborns score of 3 and greater were explored using univariable and multivariable regression models. RESULTS: All but 1 video recording in each group were analyzed. Among the 34 neonates in the experimental group, 71.4% (95% CI: [53.7-85.4]) had an Acute Pain in Newborns score of less than 3 during orogastric tube insertion versus 41% (95% CI: [27.9-61.9]) in the control group (P = .031). Gagging was frequent and nonsignificantly different between the 2 groups (69% in the control group, 51% in the experimental group, P = .13). In multivariable analysis, the experimental technique was an independent factor of pain prevention compared with the usual technique (odds ratio = 0.21 [0.06-0.71], P = .015). CONCLUSIONS: This study suggests that a simple, inexpensive, and feasible technique of orogastric tube insertion through the nipple of a bottle limits pain associated with this procedure in newborns.
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BACKGROUND: Patients in neonatal intensive care units (NICUs) are at high risk of adverse events. The effects of medical and paramedical education programmes to reduce these have not yet been assessed. METHODS: In this multicentre, stepped-wedge, cluster-randomised controlled trial done in France, we randomly assigned 12 NICUs to three clusters of four units. Eligible neonates were inpatients in a participating unit for at least 2 days, with a postmenstrual age of 42 weeks or less on admission. Each cluster followed a 4-month multifaceted programme including education about root-cause analysis and care bundles. The primary outcome was the rate of adverse events per 1000 patient-days, measured with a retrospective trigger-tool based chart review masked to allocation of randomly selected files. Analyses used mixed-effects Poisson modelling that adjusted for time. This trial is registered with ClinicalTrials.gov, NCT02598609. FINDINGS: Between Nov 23, 2015, and Nov 2, 2017, event rates were analysed for 3454 patients of these 12 NICUs for 65â830 patient-days. The event rate per 1000 patient-days reduced significantly from the control to the intervention period (33·9 vs 22·6; incidence rate ratio 0·67; 95% CI 0·50-0·88; p=0·0048). INTERPRETATION: A multiprofessional safety-promoting programme in NICUs reduced the rate of adverse events and severe and preventable adverse events in highly vulnerable patients. This programme could significantly improve care offered to critically ill neonates. FUNDING: Solidarity and Health Ministry, France.
Assuntos
Pessoal de Saúde/educação , Unidades de Terapia Intensiva Neonatal , Educação Interprofissional , Adulto , Feminino , Humanos , Recém-Nascido , MasculinoRESUMO
BACKGROUND: High P2Y12 platelet reactivity (PR) level after primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) affects prognosis and may induce the no-reflow phenomenon. AIM: To investigate the role of PR in the genesis of microvascular obstruction. METHODS: Patients with STEMI undergoing PPCI within 12hours of symptoms onset were included prospectively. All patients received a 600mg clopidogrel-loading dose before PPCI and 250mg aspirin. PR was measured thereafter during PPCI while wiring the culprit lesion and before coronary dilatation, using the P2Y12 VerifyNow® assay. No-reflow was defined as ST-segment regression<50% observed 90minutes after PPCI. RESULTS: Between January 2014 and November 2015, 140 STEMI patients were included, and divided into two groups: a low PR group (LPR) defined as PR<209P2Y12 reaction units (PRU); and a high PR group (HPR) defined as PR≥209PRU. There were no differences in baseline characteristics between LPR and HPR groups, including age (57.8±11.9 vs. 59.4±13.2 years, respectively; P=0.44) and weight (76.1±15.1 vs. 74.8±10.9kg, respectively; P=0.55). Delay to revascularization was 270.1±175.5 vs. 295.6±206.2minutes (P=0.49) and time between clopidogrel-loading and PR measurement was 53±37 vs 65±54minutes (P=0.29) in the LPR and HPR groups, respectively. No-reflow was more frequent in the HPR group (44 [47.3%] vs. 9 [19.1%]; P=0.0012). Mean PR was higher in patients with no-reflow: 268.3±53 vs. 223.8±50.1 PRU (P=0.002). In multivariable analysis, HPR was an independent predictor of no-reflow. Area under the receiver operating characteristic curve was 0.745 (0.654, 0.835); the cut-off value predicting no-reflow was 254PRU. CONCLUSION: High PR level measured at PPCI is independently associated with no-reflow.