Background: Surgery can generate significant stress and anxiety in up to 70% of the paediatric population. There are several pharmacological and non-pharmacological strategies to reduce pre-operative anxiety in children, however, they have several side effects and the available information about them is contradictory. The role of clowns and hydroxyzine in the management of anxiety is controversial, with some studies supporting and others contraindicating both strategies.Methods: We propose a randomised double-blind, controlled clinical trial that will evaluate the effectiveness of both interventions (hydroxyzine and clowns), alone or in combination, to reduce pre-operative anxiety (using the modified Yale scale of preoperative anxiety) in children aged 2–16 years undergoing outpatient surgery (n = 188).Subjects will be randomised into two groups – (1) standard procedure (parental accompaniment) combined with placebo or (2) standard procedure combined with preoperative hydroxyzine. After randomisation, they will be divided by chance into two further groups, depending on the presence of clowns on the patient’s surgery day. Control of pre-operative anxiety will be determined in the four groups by a modified Yale scale of preoperative anxiety and cortisol levels. Compliance of children during induction of anaesthesia, time until anaesthesia recovery, presence of postoperative delirium and use of analgesia until discharge will be also assessed. For additional information, the children, parents and healthcare professionals involved in the study will complete a satisfaction survey.Conclusions: This study aims to gather evidence on which of these four therapeutic options achieves the highest reduction of pre-operative anxiety with the best safety profile to allow paediatricians and anaesthesiologists to use the most effective and safe option for their patients.Trial registration: ClinicalTrials.gov identifier:NCT03324828. Registered 21 September 2017.

BACKGROUND: Various different interventions can be used to reduce surgical blood loss; however, there is no “gold standard” for accurately measuring the volume of perioperative blood loss, and this makes it difficult to assess the efficacy of these interventions. METHODS: We used data from a previous multicenter double-blind randomized clinical trial in patients undergoing total hip arthroplasty in which we compared 2 regimens for administering tranexamic acid versus placebo. We assessed direct measures (external blood loss) and indirect estimates (using the formulas of Bourke, Gross, Mercuriali, and Camarasa and a new formula we have developed) using analysis of variance to compare estimated volumes of blood loss among the study groups. In addition, intraclass correlation coefficients (ICCs) and Bland–Altman diagrams were used to compare the estimated volumes of blood loss obtained with each formula. RESULTS: The mean estimated external blood loss was 909 ± 324 mL, and the mean estimates of blood loss calculated using the formulas of Gross, Bourke and Smith, and Camarasa were 1308 ± 555, 1091 ± 454, and 1641 ± 945 mL, respectively, whereas we obtained a value of 1511 ± 919 mL with the new formula at day 2. In all cases, the results favored the use of tranexamic acid (P < .0001). Comparing results of the new and other formulas, we found moderate-to-low agreement (in terms of ICCs) except for that of Camarasa (ICC: 0.992). The limits of agreement with the new formula ranged from −378 to 93 in the case of the comparison with Camarasa’s formula and from −2226 to 959 for external blood loss, the difference depending on the magnitude of the estimate to a large extent. CONCLUSIONS: Formulas that take into account both anthropometric and laboratory parameters are useful for evaluating the efficacy of interventions aiming to decrease blood loss but do not ensure that the values obtained are sufficiently accurate for absolute measuring.

BACKGROUND: Tranexamic acid (TXA) reduces bleeding in patients undergoing hip replacement surgery, but optimal doses and timing have yet to be established. Our primary objective in this study was to assess total blood loss 48 hours after surgery with different regimens. METHODS: This was a multicenter, parallel-group, randomized, placebo-controlled clinical trial that included all ASA physical status I to III patients undergoing unilateral total hip replacement surgery who met the inclusion criteria. Patients were randomly allocated to 1 of 3 groups: a single-dose group (15 mg/kg TXA before the start of surgery and saline 3 hours later after the start of surgery), a 2-dose group (10 m/kg TXA before and 10 mg/kg of TXA 3 hours after the start of surgery), and a control group (saline before and 3 hours after the start of surgery). Total blood loss was calculated using a formula considering hematocrit values and blood transfusions received. RESULTS: We included 108 patients in the study. Total blood loss volumes up to day 2 were 1377 ± 689, 1308 ± 641, and 2215 ± 1136 mL in the single-dose, 2-dose and control groups, respectively (P < 0.001 between the placebo and the experimental groups). Blood transfusions were given to 22.9% of patients (n = 8) in the single-dose group, 11.1% (n = 4) in the 2-dose group, and 37.8% (n = 14) in the control group (P = 0.028). CONCLUSIONS: A single preoperative dose of TXA or 2 infusions of a lower dose, preoperatively and then after 3 hours after the start of surgery, resulted in lower blood loss during the first 2 days after surgery and less need for blood transfusion, with good levels of safety.

Lidocaine, a widely used local anaesthetic, has been shown to possess anti-inflammatory and immunomodulatory properties with applications in surgery. During a surgical procedure, inflammation is a natural response of the body, triggered by the release of inflammatory mediators and the activation of the immune system. However, an excessive response can lead to serious postoperative complications. Lidocaine modulates inflammation through mechanisms beyond its anaesthetic action. It reduces the activation of neutrophils and macrophages, decreases the release of pro-inflammatory cytokines and prostaglandins, and preserves endothelial integrity, helping to control excessive inflammatory responses. Additionally, its perioperative use has shown benefits such as reduced postoperative pain, lower opioid consumption, and faster intestinal recovery. Furthermore, studies have suggested that lidocaine may have an anti-metastatic effect by inhibiting the migration of tumour cells and the activation of inflammatory pathways related to cancer spread. Although its use in surgery is promising, further research is needed to determine optimal dosages and its long-term clinical impact.