Post-operative discomforts in children after extraction of primary teeth.

OBJECTIVES: This prospective observational study aimed to evaluate discomfort after extraction of deciduous teeth under local anesthesia. The primary objective was to describe the prevalence of post-extraction pain (PEP), post-extraction bleeding (PEB), post-extraction biting injury (PEBI), and analgesic usage in children. The secondary objective was to define whether it is possible to determine a profile of patients or a type of extraction procedure predictive to PEP, administration of analgesics, PEB, or PEBI. METHODS: One hundred and twenty-five children, aged 3-13 years, with indications of at least one deciduous tooth extraction, were included. Immediately after extraction, information concerning the patient and the extraction were collected. Eighteen to 32 hr after extraction, parents were called by phone to request reports concerning the onset and intensity of PEP assessed using the Wong-Baker Faces (WBF) scale, the administration of paracetamol (acetaminophen) to their children, and the appearance of PEB and/or PEBI. RESULTS: Of the children, 37.3% reported PEP (WBF ≥2), but 23.3% of these children did not receive any analgesic drugs to help relieve pain. Pain appeared before 3 hr after extraction in 69% of the children. Higher incidences of PEP and usage of analgesics were found both in the group of children with unfavorable socioeconomic level compared to favorable level and in the group with pre-operative pain compared to no pre-operative pain (p < .05). CONCLUSIONS: About a third of the children reported pain after extraction, but the instructions for pain relief were not followed by all parents. The socioeconomic level of the young patient and the pain felt during the extraction were important predictors of discomfort. Therefore, our study could help the dentist to provide information on predicted post-operative discomfort and to allow suitable care depending on the patient's profile or procedure.

Early point-of-care focused echocardiographic asystole as a predictive factor for absence of return of spontaneous circulatory in out-of-hospital cardiac arrests: a study protocol for a prospective, multicentre observational study.

INTRODUCTION: Management of out-of-hospital cardiac arrests (OHCAs) in France is performed by a particular prehospital system based on medicalisation of mobile intensive care units composed of an emergency physician and a nurse with all the required devices for advanced care. It follows the European recommendations which advocate for the use of early point-of-care focused echocardiography (EPOCE) in the prehospital setting. An ability of EPOCE may be to predict the absence of return of spontaneous circulation (ROSC) in cases of absence of cardiac motion. We thus intended to investigate this predictive value with a prospective multicentre study. This paper describes the study protocol, while the first patients were recruited in December 2018. METHODS: ACE is a prospective multicentre (n=8) prognostic study. Briefly, as soon as OHCA is diagnosed and advanced life support (ALS) is initiated, EPOCE will be performed during the automated external defibrillator' analysis period. The physician will assess detectable motion within the heart and reversible causes of OHCA. However, as the prognostic value of absence of cardiac motion is not currently validated, the results of EPOCE will not be used to withdraw ALS, and the decision to withdraw life support will be done following the European Resuscitation Council recommendations during our study. ANALYSIS: The primary endpoint is the positive predictive value of absence of cardiac motion for the absence of final ROSC. The secondary endpoints are predictive characteristics of EPOCE asystole on morbimortality 30 days after OHCA, description of reversible cause and analysis of the EPOCE technique. ETHICS AND DISSEMINATION: ACE was approved by an ethical committee (2018-AO1491-54). While ACE is adapted to the French prehospital system, its results will be translatable to other organisations if inter-rater variability is not found. TRIAL REGISTRATION NUMBER: NCT03494153.

A Randomized Controlled Trial Comparing Crude Versus Heparin-Bonded PTFE Graft in Below the Knee Bypass Surgery for Critical Limb Ischemia (REPLACE Trial): Design and Protocol.

BACKGROUND: Although autogenous venous grafts are preferable for below-the-knee bypass surgery in patients with critical limb ischemia, some 20% of patients will have no suitable vein for grafting, compelling a resort to artificial graft materials. Retrospective subgroup analyses within published studies comparing heparin-bonded polytetrafluoroethylene (PTFE) with crude PFTE graft in below-the-knee bypass suggest that heparin-bonded graft offers superior long-term patency rates, but this has not been prospectively verified in patients with critical limb ischemia. METHODS: A single-blind randomized controlled trial in 20 French centers has been designed. Patients assessed as having no suitable autologous vein for bypass grafting for critical lower limb ischemia will be randomized to receive either a heparin-bonded PTFE graft or a crude PTFE graft. A literature review suggested expected 1-year patency rates of 53% for the crude ePTFE arm and 74% for the heparin-bonded PTFE arm. On analyzing 1-year patency rate as a binary variable, for a significance level α = 0.05 and a randomization ratio of 1:1, a total of 176 patients (88 in each arm) will be required to obtain approximately 80% power to reject the null hypothesis. Assuming 10% dropout at 1 year and 20% mortality, 228 patients will be randomized (114 patients in each arm). RESULTS: The primary outcome variable will be patency at 1 year assessed by duplex ultrasound color-flow scan. Any intervention to open up or prevent a graft occlusion before 1 year will be classified as loss of patency. Technical success, deaths, complications, major adverse cardiovascular and limb events, length of hospitalization, and quality of life will also be recorded and analyzed as secondary outcome variables. Cost-utility and cost-effectiveness analyses based on standard tariffs in the French health insurance system will be performed. CONCLUSIONS: The REPLACE trial is the first randomized controlled trial designed to determine if heparin-bonded PTFE graft is superior to crude PTFE graft in below-the-knee bypass surgery for critical limb ischemia.