Need For Intravenous Rehydration Research Articles

Ondansetron orale per la gastroenterite pediatrica nelle cure primarie: uno studio randomizzato controllato che non dà utili indicazioni

Oral Ondansetron for Paediatric Gastroenteritis in Primary Care: A Randomized Controlled Trial with no useful indications This randomized controlled pragmatic study carried out in three continuity care centers in the Netherlands promotes the use of Ondansetron as an antiemetic for acute gastroenteritis in primary care. Unfortunately, during the study, the authors changed the primary outcome from "referral to hospital treatment" to "vomiting in the first 4 hours after randomization" due to the low enrolment of patients (only 194 children enrolled in 2 years by almost 600 primary care doctors). The new outcome chosen, although statistically significant, is of little clinical interest. Enrolled patients arrived at late evaluation, after a mean symptom duration of 2 days. An earlier use of ondansetron for acute gastroenteritis in the context of primary care might therefore be effective in reducing the need for intravenous rehydration, but further studies are needed.

Bovine Lactoferrin in the Prevention of Antibiotic-Associated Diarrhea in Children: A Randomized Clinical Trial.

Introduction: Antibiotic-associated diarrhea (AAD) is a common adverse reaction to antibiotic treatment affecting up to 21% of children. The aim of the study is to evaluate whether bovine lactoferrin (bLf) might be used for AAD prevention.Materials and Methods: In this prospective, randomized, double-blind, placebo-controlled, single-center study, we enrolled 156 children aged between 1 and 18 years, treated with antibiotic due to acute respiratory or urinary tract infection. We randomly allocated children 1:1 to receive 100 mg of bLf or a placebo twice a day orally for the whole period of antibiotic therapy. The primary outcome was the occurrence of antibiotic-associated diarrhea during and up to 2 weeks after antibiotic therapy. The secondary endpoint was intravenous rehydration or antibiotic withdrawal due to diarrhea. We performed intention-to-treat analysis.Results: We included 150 patients in intention-to-treat analysis. AAD occurred in 16 of 75 (21.3%) patients in bLf group and in 7 of 75 (9.3%) individuals in placebo group [OR = 2.6, (95% CI: 1.01–6.84), p = 0.04]. Relative risk was 2.29 (95% CI: 0.89–5.88). The need for intravenous rehydration occurred in one patient in the placebo group (p = 0.3). We observed no adverse effects in neither of the groups.Discussion: The trial indicated that bLf is not effective in AAD prevention. The risk for AAD was higher in bovine lactoferrin group as compared with placebo. We registered the study protocol on ClinicalTrials.gov (NCT02626104).

Antiemetics in Children With Acute Gastroenteritis: A Meta-analysis.

Several antiemetics have been used in children with acute gastroenteritis. However, there is still controversy over their use. To determine the effectiveness and safety of antiemetics for controlling vomiting in children with acute gastroenteritis. Medline, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, Latin America and the Caribbean Literature on Health Sciences, and gray literature, until December 2018. We selected randomized clinical trials comparing metoclopramide, ondansetron, domperidone, dexamethasone, dimenhydrinate, and granisetron. Two reviewers independently screened abstracts and full texts, extracted the data, and assessed the risk of bias. We performed pairwise and network meta-analysis using the random-effects model. Twenty-four studies were included (3482 children). Ondansetron revealed the largest effect in comparison to placebo for cessation of vomiting (odds ratio = 0.28 [95% credible interval = 0.16 to 0.46]; quality of evidence: high) and for hospitalization (odds ratio = 2.93 [95% credible interval = 1.69 to 6.18]; quality of evidence: moderate). Ondansetron was the only intervention that reduced the need for intravenous rehydration and the number of vomiting episodes. When considering side effects, dimenhydrinate was the only intervention that was worse than placebo. Most treatment comparisons had low- or very low-quality evidence, because of risk of biases and imprecise estimates. Ondansetron is the only intervention that revealed an effect on the cessation of vomiting, on preventing hospitalizations, and in reducing the need for intravenous rehydration. Ondansetron was also considered a safe intervention.

Gelatine tannate in the management of acute gastroenteritis in children: a randomised controlled trial

ObjectiveTo assess the efficacy of gelatine tannate (a complex of tannic acid with astringent and anti-inflammatory properties, and a protective gelatine) for the treatment of acute gastroenteritis (AGE) in children.DesignRandomised,...

Smectite for acute infectious diarrhoea in children

BackgroundAs mortality secondary to acute infectious diarrhoea has decreased worldwide, the focus shifts to adjuvant therapies to lessen the burden of disease. Smectite, a medicinal clay, could offer a complementary intervention to reduce the duration of diarrhoea.ObjectivesTo assess the effects of smectite for treating acute infectious diarrhoea in children.Search methodsWe searched the Cochrane Infectious Diseases Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Pubmed), Embase (Ovid), LILACS, reference lists from studies and previous reviews, and conference abstracts, up to 27 June 2017.Selection criteriaRandomized and quasi‐randomized trials comparing smectite to a control group in children aged one month to 18 years old with acute infectious diarrhoea.Data collection and analysisTwo review authors independently screened abstracts and the full texts for inclusion, extracted data, and assessed risk of bias. Our primary outcomes were duration of diarrhoea and clinical resolution at day 3. We summarized continuous outcomes using mean differences (MD) and dichotomous outcomes using risk ratios (RR), with 95% confidence intervals (CI). Where appropriate, we pooled data in meta‐analyses and assessed heterogeneity. We explored publication bias using a funnel plot.Main resultsEighteen trials with 2616 children met our inclusion criteria. Studies were conducted in both ambulatory and in‐hospital settings, and in both high‐income and low‐ or middle‐income countries. Most studies included children with rotavirus infections, and half included breastfed children.Smectite may reduce the duration of diarrhoea by approximately a day (MD ‐24.38 hours, 95% CI ‐30.91 to ‐17.85; 14 studies; 2209 children; low‐certainty evidence); may increase clinical resolution at day 3 (risk ratio (RR) 2.10, 95% CI 1.30 to 3.39; 5 trials; 312 children; low‐certainty evidence); and may reduce stool output (MD ‐11.37, 95% CI ‐21.94 to ‐0.79; 3 studies; 634 children; low‐certainty evidence).We are uncertain whether smectite reduces stool frequency, measured as depositions per day (MD ‐1.33, 95% CI ‐2.28 to ‐0.38; 3 studies; 954 children; very low‐certainty evidence). There was no evidence of an effect on need for hospitalization (RR 0.93, 95% CI 0.75 to 1.15; 2 studies; 885 children; low‐certainty evidence) and need for intravenous rehydration (RR 0.77, 95% CI 0.54 to 1.11; 1 study; 81 children; moderate‐certainty evidence). The most frequently reported side effect was constipation, which did not differ between groups (RR 4.71, 95% CI 0.56 to 39.19; 2 studies; 128 children; low‐certainty evidence). No deaths or serious adverse effects were reported.Authors' conclusionsBased on low‐certainty evidence, smectite used as an adjuvant to rehydration therapy may reduce the duration of diarrhoea in children with acute infectious diarrhoea by a day; may increase cure rate by day 3; and may reduce stool output, but has no effect on hospitalization rates or need for intravenous therapy.

Clinical Practice: Nausea and vomiting in acute gastroenteritis: physiopathology and management.

Well-designed investigations suggest that antagonists of the type 3 serotonin receptor, most frequently oral ondansetron, reduce the rate of vomiting, improve the tolerance of oral rehydration, and reduce the need for intravenous rehydration. What is Known: • Although children with gastroenteritis habitually have vomiting, current recommendations do not focus on the correction of this symptom. What is New: • Recently acquired evidence supports the prescription of ondansetron, an antagonist of the type 3 serotonin receptor, to increase the success rate of oral rehydration therapy.

Oral Ondansetron versus Domperidone for Acute Gastroenteritis in Pediatric Emergency Departments: Multicenter Double Blind Randomized Controlled Trial.

The use of antiemetics for vomiting in acute gastroenteritis in children is still a matter of debate. We conducted a double-blind randomized trial to evaluate whether a single oral dose of ondansetron vs domperidone or placebo improves outcomes in children with gastroenteritis. After failure of initial oral rehydration administration, children aged 1–6 years admitted for gastroenteritis to the pediatric emergency departments of 15 hospitals in Italy were randomized to receive one oral dose of ondansetron (0.15 mg/kg) or domperidone (0.5 mg/kg) or placebo. The primary outcome was the percentage of children receiving nasogastric or intravenous rehydration. A p value of 0.014 was used to indicate statistical significance (and 98.6% CI were calculated) as a result of having carried out two interim analyses. 1,313 children were eligible for the first attempt with oral rehydration solution, which was successful for 832 (63.4%); 356 underwent randomization (the parents of 125 children did not give consent): 118 to placebo, 119 to domperidone, and 119 to ondansetron. Fourteen (11.8%) needed intravenous rehydration in the ondansetron group vs 30 (25.2%) and 34 (28.8%) in the domperidone and placebo groups, respectively. Ondansetron reduced the risk of intravenous rehydration by over 50%, both vs placebo (RR 0.41, 98.6% CI 0.20–0.83) and domperidone (RR 0.47, 98.6% CI 0.23–0.97). No differences for adverse events were seen among groups. In a context of emergency care, 6 out of 10 children aged 1–6 years with vomiting due to gastroenteritis and without severe dehydration can be managed effectively with administration of oral rehydration solution alone. In children who fail oral rehydration, a single oral dose of ondansetron reduces the need for intravenous rehydration and the percentage of children who continue to vomit, thereby facilitating the success of oral rehydration. Domperidone was not effective for the symptomatic treatment of vomiting during acute gastroenteritis.

Assessment of effectiveness of nonspecific antidiarrheal agents in reducing the need for intravenous rehydration in children with acute diarrhea

Background: In clinical practice, nonspecific antidiarrheals are most commonly used by clinicians along with routine treatment to hasten the recovery and to give psychological reassurance. This study was conducted to assess the effectiveness of nonspecific antidiarrheal agents in reducing the need for intravenous rehydration in children with acute diarrhea. Materials and Methods: This was a prospective, observational study done in clinical settings for a period of 3 years at two pediatric clinics and at a tertiary care hospital. Children were divided into 5 treatment groups (viz, control, racecadotril, Mebarid, Diarex and loperamide) at the discretion of the pediatrician. One questionnaire was provided to parents to record the details about the course of diarrhea. Parents were sensitized to report any episode of complication or need for intravenous fluids. Results: The unscheduled need for intravenous fluids due to dehydration was significantly higher in control group compared to other groups {Control: 7.37%, Racecadotril : 1.71% Mebarid: 2.4%, Diarex: 0%, Loperamide : 0%)}. Conclusion: Present study suggests that use of nonspecific antidiarrheals may decrease the need for admission for intravenous fluids in children with acute diarrhea.

Clinical and Economic Impact of Oral Ondansetron for Vomiting in a Pediatric Emergency Department

In this study, we determine the clinical impact of 1 dose of oral ondansetron for children with vomiting and evaluate the economic consequences of its use. The strategies compared were administering oral ondansetron in addition to oral rehydration therapy (group A) versus oral rehydration solution alone (group B) in children attended to for vomiting in a pediatric emergency department. The study population was 1871 children between 0 and 14 years of age treated for vomiting during a 2-year period (2009-2010). Outcome measures were need for intravenous rehydration, length of stay in the emergency department, return visits, and hospitalization. Estimates of the costs in the emergency department and hospitalization were derived from administrative databases. During the study period, 580 (31%) of 1871 patients received oral rehydration therapy. Oral ondansetron before oral rehydration solution was used in 109 (18.8%) of 580 patients. An equal number of patients not receiving ondansetron were randomized and analyzed for comparison (group B). Patients of group A had a significantly decreased risk of hospitalization (relative risk, 0.22; 95% confidence interval, 0.08-0.63) and intravenous rehydration (relative risk, 0.31; 95% confidence interval, 0.14-0.63), but there were no differences in the length of stay or return visits to the emergency department. There were no differences in the medical costs between both groups in the emergency department (US $22,078 vs US $21,987, respectively). The hospitalization cost was US $9600 for group A and US $25,079 for group B, providing a 73.7% saving. In conclusion, the administration of oral ondansetron to children with vomiting in the emergency department is clinically effective and results in significant economic savings.

Evaluation of a Clinical Dehydration Scale in Children Requiring Intravenous Rehydration

OBJECTIVES: To evaluate the reliability and validity of a previously derived clinical dehydration scale (CDS) in a cohort of children with gastroenteritis and evidence of dehydration. METHODS: Participants were 226 children older than 3 months who presented to a tertiary care emergency department and required intravenous rehydration. Reliability was assessed at treatment initiation, by comparing the scores assigned independently by a trained research nurse and a physician. Validity was assessed by using parameters reflective of disease severity: weight gain, baseline laboratory results, willingness of the physician to discharge the patient, hospitalization, and length of stay. RESULTS: Interobserver reliability was moderate, with a weighted κ of 0.52 (95% confidence interval [CI] 0.41, 0.63). There was no correlation between CDS score and percent weight gain, a proxy measure of fluid deficit (Spearman correlation coefficient = −0.03; 95% CI −0.18, 0.12). There were, however, modest and statistically significant correlations between CDS score and several other parameters, including serum bicarbonate (Pearson correlation coefficient = −0.35; 95% CI −0.46, −0.22) and length of stay (Pearson correlation coefficient = 0.24; 95% CI 0.11, 0.36). The scale’s discriminative ability was assessed for the outcome of hospitalization, yielding an area under the receiver operating characteristic curve of 0.65 (95% CI 0.57, 0.73). CONCLUSIONS: In children administered intravenous rehydration, the CDS was characterized by moderate interobserver reliability and weak associations with objective measures of disease severity. These data do not support its use as a tool to dictate the need for intravenous rehydration or to predict clinical course. * Abbreviations: AUC — : area under the curve CDS — : clinical dehydration scale CI — : confidence interval ED — : emergency department IQR — : interquartile range ROC — : receiver operating characteristic

Evaluation of a Clinical Dehydration Scale in Children Requiring Intravenous Rehydration

To evaluate the reliability and validity of a previously derived clinical dehydration scale (CDS) in a cohort of children with gastroenteritis and evidence of dehydration. Participants were 226 children older than 3 months who presented to a tertiary care emergency department and required intravenous rehydration. Reliability was assessed at treatment initiation, by comparing the scores assigned independently by a trained research nurse and a physician. Validity was assessed by using parameters reflective of disease severity: weight gain, baseline laboratory results, willingness of the physician to discharge the patient, hospitalization, and length of stay. Interobserver reliability was moderate, with a weighted κ of 0.52 (95% confidence interval [CI] 0.41, 0.63). There was no correlation between CDS score and percent weight gain, a proxy measure of fluid deficit (Spearman correlation coefficient = -0.03; 95% CI -0.18, 0.12). There were, however, modest and statistically significant correlations between CDS score and several other parameters, including serum bicarbonate (Pearson correlation coefficient = -0.35; 95% CI -0.46, -0.22) and length of stay (Pearson correlation coefficient = 0.24; 95% CI 0.11, 0.36). The scale's discriminative ability was assessed for the outcome of hospitalization, yielding an area under the receiver operating characteristic curve of 0.65 (95% CI 0.57, 0.73). In children administered intravenous rehydration, the CDS was characterized by moderate interobserver reliability and weak associations with objective measures of disease severity. These data do not support its use as a tool to dictate the need for intravenous rehydration or to predict clinical course.

Effect on Infant Illness of Maternal Supplementation With 400 000 IU Vs 200 000 IU of Vitamin A

Postpartum vitamin A supplementation is a strategy used to combat vitamin A deficiency and seems to reduce maternal/infant morbidity and mortality. However, studies have shown that a dose of 200 000 IU (World Health Organization [WHO] protocol) does not seem to provide adequate retinol levels in maternal breast milk, infant serum, and infant tissue. The objective of this study was to compare the effect of postpartum maternal supplementation with 400 000 IU (International Vitamin A Consultative Group protocol) compared with 200 000 IU of vitamin A on infant morbidity. This was a randomized controlled, triple-blinded clinical trial conducted at 2 public maternity hospitals in Recife in northeastern Brazil. There were 276 mother-child pairs that were allocated to 2 treatment groups: 400 000 IU or 200 000 IU of vitamin A. They were followed up for >6 months to evaluate infant morbidity. Fever (rate ratio [RR]: 0.92 [95% confidence interval (CI): 0.75-1.14]), diarrhea (RR: 0.96 [95% CI: 0.72-1.28]), otitis (RR: 0.94 [95% CI: 0.48-1.85]), acute respiratory infection (RR: 1.03 [95% CI: 0.88-1.21]), the need for intravenous rehydration (RR: 2.08 [95% CI: 0.64-2.07]), and the use of antibiotic treatment (RR: 0.80 [95% CI: 0.43-1.47]) did not differ significantly between the 2 treatment groups. Our findings suggest that postpartum maternal supplementation with 400 000 IU of vitamin A does not provide any additional benefits in the reduction of illness in children aged <6 months; therefore, we do not support the proposal to increase the standard vitamin A dose in the existing WHO protocol.

Time‐series Analysis of Ondansetron Use in Pediatric Gastroenteritis

Emergency department use of ondansetron in children with gastroenteritis is increasing; however, its effect on clinical outcomes is unknown. We aimed to determine whether increasing ondansetron usage is associated with improved outcomes in children with gastroenteritis. A retrospective cohort study was conducted at The Hospital for Sick Children, Toronto, Canada. Eligible children included those younger than 18 years old with gastroenteritis who presented to an emergency department between 2003 and 2008. There were 22,125 potentially eligible visits; 20% were selected at random for chart review. The primary outcome measure, the intravenous rehydration rate, was evaluated using an interrupted time-series analysis with segmented logistic regression. Secondary outcomes included emergency department revisits, hospitalization, and length of stay. A total of 3508 patient visits were included in the final analysis. During the study period, there was a significant reduction in intravenous rehydration usage (27%-13%; P < 0.001) and an increase in ondansetron administration (1%-18%; P < 0.001). Time-series analysis demonstrated a level break (P = 0.03) following the introduction of ondansetron. The mean length of stay for children declined from 8.6 ± 3.4 to 5.9 ± 2.8 hours, P = 0.03. During the week following the index visit, there was a reduction in return visits (18%-13%; P = 0.008) and need for intravenous rehydration (7%-4%; P = 0.02). Ondansetron use has increased significantly and is associated with reductions in the use of intravenous rehydration, emergency department revisits, and length of stay. The selective use of ondansetron is associated with improved clinical outcomes.

Evaluating outcomes associated with a discharge action plan employing single-dose home use of ondansetron in patients with acute gastroenteritis.

Acute gastroenteritis accounts for 1–2 million annual pediatric emergency department visits in the US. The current literature supports the use of antiemetics, such as ondansetron, in the emergency department, reporting improved oral rehydration, cessation of vomiting, and reduction in the need for intravenous rehydration. However, there remains concern that using these agents may “mask alternative diagnoses” and negatively impact patient care. We present a case series of 29 patients who received a pediatric emergency department discharge action plan which allowed for a dose of ondansetron to be dispensed by the clinician at the time of discharge. Patients were instructed to administer the ondansetron at home for treatment of ongoing nausea and vomiting any time after 6 hours from the time of emergency department discharge. These patients were followed up at 3–5 days following discharge to assess for outcomes. Implications of this discharge action plan and future directions are discussed.

Epidemiology and clinical features of gastroenteritis in hospitalised children: prospective survey during a 2-year period in a Parisian hospital, France

Rotavirus is recognised as the most important agent of severe acute gastroenteritis (AGE) in young children. In a 2-year prospective survey, we investigated the epidemiology and clinical features of the viral and bacterial pathogens in children hospitalised for AGE. The study was performed in a Parisian teaching hospital from November 2001 to May 2004. Clinical data were prospectively collected to assess the gastroenteritis severity (20-point Vesikari severity score, the need for intravenous rehydration, duration of hospitalisation). Stools were systematically tested for group A rotavirus, norovirus, astrovirus and adenovirus 40/41, sapovirus and Aichi virus and enteropathogenic bacteria. A total of 457 children (mean age 15.9months) were enrolled. Viruses were detected in 305 cases (66.7%) and bacteria in 31 cases (6.8%). Rotaviruses were the most frequent pathogen (48.8%), followed by noroviruses (8.3%) and adenoviruses, astroviruses, Aichi viruses and sapoviruses in 3.5%, 1.5%, 0.9% and 0.4%, respectively. Cases of rotavirus gastroenteritis were significantly more severe than those of norovirus with respect to the Vesikari score, duration of hospitalisation and the need for intravenous rehydration. Rotaviruses were the most frequent and most severe cause in children hospitalised for AGE, and noroviruses also account for a large number of cases in this population.

Oral Diosmectite Reduces Stool Output and Diarrhea Duration in Children With Acute Watery Diarrhea

Diosmectite is a clay used to treat children with acute watery diarrhea. However, its effects on stool output reduction, the key outcome for pediatric antidiarrheal drugs, have not been shown. Two parallel, double-blind studies of diosmectite efficacy on stool reduction were conducted in children 1 to 36 months old in Peru (n = 300) and Malaysia (n = 302). Inclusion criteria included 3 or more watery stools per day for less than 72 hours and weight/height ratios of 0.8 or greater. Exclusion criteria were the need for intravenous rehydration, gross blood in stools, fever higher than 39 degrees C, or current treatment with antidiarrheal or antibiotic medications. Rotavirus status was determined. Diosmectite dosage was 6 g/day (children 1-12 months old) or 12 g/day (children 13-36 months old), given for at least 3 days, followed by half doses until complete recovery. Patients were assigned randomly to groups given diosmectite or placebo, in addition to oral rehydration solution (World Health Organization). Children in each study had comparable average ages and weights. The frequencies of rotavirus infection were 22% in Peru and 12% in Malaysia. Similar amounts of oral rehydration solution were given to children in the diosmectite and placebo groups. Stool output was decreased significantly by diosmectite in both studies, especially among rotavirus-positive children. In pooled data, children had a mean stool output of 94.5 +/- 74.4 g/kg of body weight in the diosmectite group versus 104.1 +/- 94.2 g/kg in the placebo group (P = .002). Diarrhea duration was reduced by diosmectite, which was well tolerated. These results show that diosmectite significantly decreased stool output in children with acute watery diarrhea, especially those who were rotavirus-positive.

Urine Specific Gravity and Other Urinary Indices

Urine output, specific gravity, and ketones (urinary indices) are commonly used as an objective means to assess for dehydration and gastroenteritis severity; however, their utility has not been established. The study was designed to evaluate the accuracy of urinary indices as diagnostic tests to identify acute dehydration. We completed a prospective cohort study in the Emergency Department of an urban pediatric hospital. Seventy-nine subjects ages 3 months to 36 months with gastroenteritis, clinically suspected moderate dehydration, and the need for intravenous rehydration were enrolled in the trial. Urine specific gravity and urine ketone levels were determined with bedside calorimetric (dipstick) testing, and urine output during rehydration and observation was measured by commonly used techniques. An internally validated, weight-based criterion standard for the percent dehydration on enrollment was used to identify the cohort of dehydrated subjects. Correlation statistics were calculated for urine output, specific gravity, and ketones. In addition, multilevel tables were created to determine the sensitivity, specificity, and likelihood ratio at varying test cutoff values to detect 3% and 5% dehydration. Urine specific gravity (r = -0.06, P = 0.64), urine ketones (r = 0.08, P = 0.52), and urine output during rehydration (r = 0.01, P = 0.96) did not correlate with the initial degree of dehydration present. Clinically useful cutoff values for urine specific gravity and ketones to increase or decrease the likelihood of dehydration at the time of enrollment could not be identified. Urinary indices are not useful diagnostic tests to identify the presence of dehydration during the initial assessment of children with gastroenteritis.