Oral ondansetron versus domperidone for symptomatic treatment of vomiting during acute gastroenteritis in children: multicentre randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Vomiting in children with acute gastroenteritis (AG) is not only a direct cause of fluid loss but it is also a major factor of failure of oral rehydration therapy (ORT). Physicians who provide care to paediatric patients in the emergency department (ED) usually prescribe intravenous fluid therapy (IVT) for mild or moderate dehydration when vomiting is the major symptom. Thus, effective symptomatic treatment of vomiting would lead to an important reduction in the use of IVT and, consequently, of the duration of hospital stay and of frequency of hospital admission. Available evidence on symptomatic treatment of vomiting shows the efficacy of the most recently registered molecule (ondansetron) but a proper evaluation of antiemetics drugs largely used in clinical practice, such as domperidone, is lacking.</p> <p>Objectives</p> <p>To compare the efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children with AG who have failed ORT.</p> <p>Methods/Design</p> <p>Multicentre, double-blind randomized controlled trial conducted in paediatric EDs. Children aged from 1 to 6 years who vomiting, with a presumptive clinical diagnosis of AG, and without severe dehydration will be included. After the failure of a initial ORS administration in ED, eligible children will be randomized to receive: 1) ondansetron syrup (0,15 mg/Kg of body weight); 2) domperidone syrup (0,5 mg/Kg of body weight); 3) placebo. The main study outcome will be the percentage of patients needing nasogastric or IVT after symptomatic oral treatment failure, defined as vomiting or fluid refusal after a second attempt of ORT. Data relative to study outcomes will be collected at 30 minute intervals for a minimum of 6 hours. A telephone follow up call will be made 48 hours after discharge. A total number of 540 children (i.e. 180 patients in each arm) will be enrolled.</p> <p>Discussion</p> <p>The trial results would provide evidence on the efficacy of domperidone, which is largely used in clinical practice despite the lack of proper evaluation and a controversial safety profile, as compared to ondansetron, which is not yet authorized in Italy despite evidence supporting its efficacy in treating vomiting. The trial results would contribute to a reduction in the use of IVT and, consequently, in hospital admissions in children with AG. The design of this RCT, which closely reflect current clinical practice in EDs, will allow immediate transferability of results.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01257672">NCT01257672</a></p

Effective lifetime measurements in the B-s(0) -> K+K-, B-0 -> K+pi(-) and B-s(0) -> pi K-+(-) decays

Measurements of the effective lifetimes in the B-s(0) -> K+K-, B-0 -> K+pi(-) and B-s(0) -> pi K-+(-) decays are presented using 1.0 fb(-1)of pp collision data collected at a centre-of-mass energy of 7 TeV by the LHCb experiment. The analysis uses a data-driven approach to correct for the decay time acceptance. The measured effective lifetimes are tau(Bs0 -> K+K-) = 1.407 +/- 0.016 (stat) +/- 0.007 (syst) ps, tau(Bs0 -> K+pi-) = 1.524 +/- 0.011 (stat) +/- 0.004 (syst) ps, tau(Bs0 ->pi+K-) = 1.60 +/- 0.06 (stat) +/- 0.01 (syst) ps. This is the most precise determination to date of the effective lifetime in the B-s(0) -> K+K- decay and provides constraints on contributions from physics beyond the Standard Model to the B-s(0) mixing phase and the width difference Delta Gamma(s). (C) 2014 The Authors. Published by Elsevier B.V

Search for the decay D-0 -> pi(+)pi(-)mu(+)mu(-)

A search for the D-0 -> pi(+)pi(-)mu(+)mu(-) decay, where the muon pair does not originate from a resonance, is performed using proton-proton collision data corresponding to an integrated luminosity of 1.0 fb(-1) recorded by the LHCb experiment at a centre-of-mass energy of 7 TeV. No signal is observed and an upper limit on the relative branching fraction with respect to the resonant decay mode D-0 -> pi(+)pi(-)phi(-> mu(+)mu(-)), under the assumption of a phase-space model, is found to be B(D-0 -> pi(+)pi(-)mu(+)mu(-))/B(D-0 -> pi(+)pi(-)phi(-> mu(+)mu(-))) pi(+)pi(-)mu(+)mu(-)) < 5.5 x 10(-7) at 90% confidence level. This is the most stringent to date

Measurement of the lifetime of the B-c(+) meson using the B-c(+) -> J/psi pi(+) decay mode

The difference in total widths between the B-c(+) and B+ mesons is measured using a data sample corresponding to an integrated luminosity of 3.0 fb(-1) collected by the LHCb experiment in 7 and 8 TeV centre-of-mass energy proton-proton collisions at the LHC. Through the study of the time evolution of B-c(+) -> J/psi pi(+) and B+ -> J/psi K+ decays, the width difference is measured to be Delta Gamma = Gamma(Bc+) - Gamma(Bc+) = 4.46 +/- 0.14 +/- 0.07 mm(-1) c, where the first uncertainty is statistical and the second systematic. The known lifetime of the B+ meson is used to convert this to a precise measurement of the B-c(+) clifetime, tau(Bc+) = 513.4 +/- 11.0 +/- 5.7 fs, where the first uncertainty is statistical and the second is systematic. (C) 2015 The Authors. Published by Elsevier B.V

Observation of the decay B-s(0) -> (D)over-bar(0)phi

First observation of the decay B-s(0) -> (D) over bar (0)phi is reported using pp collision data, corresponding to an integrated luminosity of 1.0 fb(-1), collected by the LHCb experiment at a centre-of-mass energy of 7 TeV. The significance of the signal is 6.5 standard deviations. The branching fraction is measured relative to that of the decay B-S(0) -> (D) over bar (0)phi to be beta B-S(0) -> (D) over bar (0)phi/beta B-S(0) -> (D) over bar (0)(K) over bar*(0) = 0.069 +/- 0.013 (stat) +/- 0.007 (syst). The first measurement of the ratio of branching fractions for the decays beta B-S(0) -> (D) over bar (0)(K) over bar*(0) and beta B-S(0) -> (D) over bar (0)(K) over bar*(0) is found to be beta B-S(0) -> (D) over bar (0)(K) over bar*(0/)beta B-S(0) -> (D) over bar (0)(K) over bar*(0=7.8) +/- 0.7(stat) +/- 0.3 (syst) +/- 0.6 (f(s)/f(d)) where the last uncertainty is due to the ratio of the B(s)(0)and B-0 fragmentation fractions

First measurement of time-dependent CP violation in Bs0→K+K− B_s^0\to K^+K^- decays

Direct and mixing-induced CP-violating asymmetries in B-s(0) -> K+K- decays are measured for the first time using a data sample of p p collisions, corresponding to an integrated luminosity of 1.0 fb(-1), collected with the LHCb detector at a centre-of-mass energy of 7 TeV. The results are C-KK = 0.14 +/- 0.11 +/- 0.03 and S-KK = 0.30 +/- 0.12 +/- 0.04, where the first uncertainties are statistical and the second systematic. The corresponding quantities are also determined for B-0 -> pi(+)pi(-) decays to be C-pi pi = -0.38 +/- 0.15 +/- 0.02 and S-pi pi = -0.71 +/- 0.13 +/- 0.02, in good agreement with existing measurements

Observation of B-s(0) -> chi(c1)phi decay and study of B-0 -> chi K-c1,K-2*(0) decays

The first observation of the decay B-s(0) -> chi(c1)phi and a study of B-0 -> chi K-c1,K-2*(0) decays are presented. The analysis is performed using a dataset, corresponding to an integrated luminosity of 1.0 fb(-1), collected by the LHCb experiment in pp collisions at a centre-of-mass energy of 7 TeV. The following ratios of branching fractions are measured: B(B-s(0) -> chi(c1)phi)/B(B-s(0) -> J/psi phi) = (18.9 +/- 1.8 (stat) +/- 1.3 (syst) +/- 0.8(B)) x 10(-2), B(B-0 -> chi K-c1*(0))//B(B-0 -> J/psi K*(0)) = (19.8 +/- 1.1 (stat) +/- 1.2 (syst) +/- 0.9(B)) x 10(-2), B(B-0 -> chi K-c2*(0))//B(B-0 -> chi K-c1*(0)) = (17.1 +/- 5.0 (stat) +/- 1.7 (syst) +/- 1.1(B)) x 10(-2), where the third uncertainty is due to the limited knowledge of the branching fractions of chi(c) -> J/psi gamma modes

Measurement of the charge asymmetry in B-+/- -> phi K +/- and search for B-+/- -> phi pi(+/-) decays

The CP-violating charge asymmetry in B-+/- -> phi K-+/- decays is measured in a sample of pp collisions at 7 TeV centre-of-mass energy, corresponding to an integrated luminosity of 1.0 fb-1 collected by the LHCb experiment. The result is A(CP)(B-+/- -> phi K-+/-) = 0.022 +/- 0.021 +/- 0.009, where the first uncertainty is statistical and the second systematic. In addition, a search for the B-+/- -> phi pi(+/-) decay mode is performed, using the B-+/- -> phi K-+/- decay rate for normalization. An upper limit on the branching fraction B(B-+/- -> phi pi(+/-)) < 1.5 x 10(-7) is set at 90% confidence level. (C) 2013 The Authors. Published by Elsevier B.V. All rights reserved

Measurement of the flavour-specific CP-violating asymmetry a(sl)(s) in B-s(0) decays

The CP-violating asymmetry a(sl)(s), is studied using semileptonic decays of B-s(0) and (B) over bar (0)(s) mesons produced in pp collisions at a centre-of-mass energy of 7 TeV at the LHC, exploiting a data sample corresponding to an integrated luminosity of 1.0 fb(-1). The reconstructed final states are D-s(+/-)mu(+/-)(s), with the D-s(+/-) particle decaying in the phi pi(+/-) mode. The D-s(+/-)mu(+/-)(s) yields are summed over B-s(0) and (B) over bar (0)(s) initial states, and integrated with respect to decay time. Data-driven methods are used to measure efficiency ratios. We obtain a(sl)(s) = (-0.06 +/- 0.50 +/- 0.36)%, where the first uncertainty is statistical and the second systematic