Oral Ondansetron Research Articles

Associations with early vomiting when using intranasal fentanyl and nitrous oxide for procedural sedation in children: A secondary analysis of a randomised controlled trial.

Intranasal (IN) fentanyl and nitrous oxide (N2O) can be combined to provide procedural sedation and analgesia to children. This combination is advantageous because of rapid onset of action and non-parenteral administration, but is associated with increased vomiting. We sought to describe the associations of demographic and procedural factors with early vomiting when using this combination in children. This was a planned secondary analysis of a randomised controlled trial comparing the effect of oral ondansetron versus placebo at a single paediatric hospital. Children aged 3 to <18 years with planned procedural sedation with IN fentanyl and N2O were randomised to receive oral ondansetron or placebo prior to N2O administration. Vomiting was defined as early if occurring during or up to 1 h after N2O delivery. We assessed the relationship between early vomiting, demographic and procedural characteristics. Participants were recruited between October 2016 and January 2019 and 62 out of 436 (14%) had early vomiting. The risk of early vomiting was 30% higher with higher total dose of fentanyl, risk ratio = 1.3 (95% confidence interval = 1.004-1.59). There was little evidence of a relationship between the occurrence of early vomiting and sex, age, weight, type of procedure, fasting duration, time between fentanyl administration and start of procedure, and procedure duration. We found that higher doses of IN fentanyl were associated with higher risk of early vomiting when administered with N2O in children. Other factors did not appear to be associated with vomiting.

Costs and access barriers to ondansetron: A national analysis of Medicare part D and Medicare Advantage plans.

e23126 Background: Seniors living with cancer and receiving prescription drug benefits through Medicare Part D Prescription Drug Plans (PDPs) can face cost and access barriers in the forms of prior authorization and quantity limit policies. While over half of Medicare beneficiaries are now insured with drug benefits through Medicare Advantage, it remains unclear how costs and access barriers compare between PDPs and MA drug plans (MADPs). This study compared plan-level costs and prevalence of prior authorization or quantity limit policies between PDPs and MADPs for oral ondansetron, an essential and widely used antiemetic for patients with cancer. Methods: We used 2023 Q3 MA and PDP data from the Center for Medicare and Medicaid Services, excluding employer-sponsored and Supplemental Need Plans (including dual-eligible plans) and plans with &lt; 10 enrollees. We focused on the four most common generic ondansetron forms: 4mg and 8mg tablets, and 4mg and 8mg orally disintegrating tablets (ODT). To compare medication quantities, we calculated the median (IQR) cost of 30-day supply (90 dosage units), defining plan-level price as the average unit cost for each formulation. Price benchmarks were defined using Mark Cuban Cost-plus Drug Company cash prices, which reflect fixed markup to negotiated wholesale prices. T-test and Chi-square tests were used for comparison. Results: Across 813 PDPs and 3512 MADPs, MAPDs had lower median costs for a 30-day supply of ondansetron than PDP plans (4mg tab: $16.1 vs $29.2; 4mg ODT: $38.0 vs $56.4; 8mg tab: $24.7 vs $35.6; 8mg ODT: $37.2 vs $54.4, all p &lt; 0.01). Median costs for both PDPs and MAPDs were higher than benchmarks (66-155% across formulations; all p &lt; 0.01). PDPs and MAPDs had similarly high prior authorization rates (83.6% vs 83.4%, p = 0.89), but MAPDs used quantity limits more frequently (22.5% vs 16.5%, p &lt; 0.01). There was little variation in prior authorization and quantity limit policies across formulations. Conclusions: Ondansetron costs in both PDPs and MAPDs were higher than benchmarks. Compared to PDPs, MAPDs offered ondansetron at lower costs but used policies creating access barriers for patients either at similar (prior authorization) or higher (quantity limit) frequency, burdening patients, physicians, health systems, and pharmacies. [Table: see text]

The efficacy of combining ondansetron with dexamethasone in delayed chemotherapy-induced nausea and vomiting

Background: Chemotherapy is the primary recourse for patients with cancer that cannot be treated using local surgery or radiotherapy. Its practical application often leads to adverse effects, including nausea and vomiting. Objective: This study determined the efficacy of oral ondansetron and oral dexamethasone as an antiemetic regimen among patients covered by the National Health Insurance. Methods: This cross-sectional study, conducted at one of the largest hospitals in South Kalimantan, Indonesia, involved 114 chemotherapy patients who received a combination antiemetic regimen of ondansetron and dexamethasone. Data on the incidence of delayed nausea and vomiting after chemotherapy were collected using the Index Nausea Vomiting and Retching (INVR) questionnaire from March to May 2023. Results: A cohort of 114 individuals were enrolled in the present investigation, with 57.02% and 42.98% of the participants receiving non-anthracycline and anthracycline-based treatment protocols, respectively. The results showed that only 1.84% of patients did not experience chemotherapy-related adverse events, 13.16% experienced mild symptoms, 21.84% had moderate symptoms, 55.26% faced severe symptoms, and 7.89% suffered from intense symptoms of nausea and vomiting. Conclusion: The antiemetic regimen covered by Badan Penyelenggara Jaminan Sosial (BPJS) (Social Insurance Administration Organization), consisting of a combination of ondansetron and dexamethasone, is moderately effective in preventing chemotherapy-induced delayed nausea and vomiting.

Plasma Concentrations of Oral Ondansetron in Hospitalized Dogs Exhibiting Clinical Signs of Nausea.

The purpose of this study was to evaluate plasma ondansetron (OND) concentrations in a population of dogs with naturally occurring nausea after oral OND administration. Twenty-four dogs were randomly assigned to receive one of the following doses of oral OND: 0.5 mg/kg q8h, 0.5 mg/kg q12h, 1 mg/kg q8h, or 1 mg/kg q12h. Blood samples for plasma OND measurements were collected at baseline and 2, 4, and 8 h after administration of the first dose of OND. OND concentrations averaged over an 8 h time period were not significantly different between dose groups (0.5 mg/kg group: median 8.5 ng/mL [range 1-96.8 ng/mL], 1 mg/kg group: median 7.4 ng/mL [range 1-278.7 ng/mL]). The mean maximum concentrations in the 0.5 mg/kg and 1 mg/kg groups were 35.8 ± 49.0 ng/mL and 63.3 ± 121.1 ng/mL, respectively. OND concentrations were below the lower limit of quantification (LLOQ) in 50% (18/36) of samples in the 0.5 mg/kg groups and 39% (14/36) of samples in the 1 mg/kg groups. Six dogs (6/24, 25%) did not have OND detected at any time. The mean nausea scores at baseline were similar amongst all groups and decreased over time. The bioavailability of oral OND appears to be poor. Despite low plasma OND concentrations, nausea scores improved over time.

Ondansetron and the Risk of Sudden Cardiac Death among Individuals Receiving Maintenance Hemodialysis.

Individuals receiving hemodialysis have high incidence of sudden cardiac death and are susceptible to QT interval prolonging medication-related cardiac complications. Ondansetron, an antiemetic with known QT prolonging potential, is associated with fatal arrythmias in the general population when administered intravenously. The cardiac safety of ondansetron in the hemodialysis population is unknown. We conducted a new-user, active-comparator, cohort study using US Renal Data System data (2012-2019) to examine the association between the initiation of oral ondansetron vs. antiemetics with lesser QT prolonging potential (promethazine, metoclopramide or prochlorperazine) and the 10-day risk of sudden cardiac death among individuals receiving hemodialysis. We used inverse probability of treatment weighted survival models to estimate adjusted hazard ratios (aHRs), risk differences (aRDs), and 95% confidence intervals (CIs). We used an intention-to-treat approach in which non-sudden cardiac death was considered a competing event. We examined additional cardiac outcomes in secondary analyses. Of the 119,254 study patients, 64,978 (54.5%) initiated ondansetron, and 54,276 (45.5%) initiated a comparator antiemetic. Initiation of ondansetron versus a comparator antiemetic was associated with higher relative and absolute 10-day risks of sudden cardiac death, aHR (95% CI) = 1.44 (1.08, 1.93); aRD (95% CI) = 0.06% (0.01%, 0.11%). The number needed to harm was 1,688. Analyses of additional cardiac outcomes yielded similar findings. Compared with initiation of antiemetics with lesser QT prolonging potential, initiation of ondansetron was associated with higher short-term cardiac risks among people receiving hemodialysis.

Review article: Efficacy of prophylactic ondansetron versus placebo or control in reducing vomiting in children undergoing ketamine procedural sedation in the emergency department: A systematic review and meta-analysis.

Ketamine is commonly used for procedural sedation anaesthesia in paediatric patients undergoing painful procedures in the ED. Ketamine's safety profile is excellent, but ketamine-associated vomiting (KAV) is common. Routine ondansetron prophylaxis could reduce KAV incidence. This literature review evaluated the efficacy of prophylactic ondansetron in reducing KAV incidence. A systematic literature review was performed on databases and trial registries on 14 January 2023 to identify randomised controlled trials. The primary outcome was reduction in KAV incidence, for any route of prophylactic ondansetron, in ED and up to 24 h post-discharge. ED length of stay, parental satisfaction and time to resumption of normal diet were secondary outcomes. Data analysis was performed using Revman 5.3. Meta-analysis was performed using random effects modelling. Risk of bias was assessed using the Cochrane Risk-of-Bias 2 tool. Evidence quality was assessed using Grading of Recommendation, Assessment Development and Evaluation methodology. Five trials with 920 participants met the eligibility criteria. Prophylactic ondansetron resulted in a reduction in KAV incidence overall odds ratio of 0.51 (95% confidence interval: 0.36-0.73). Intravenous and intramuscular prophylactic ondansetron showed benefit whereas the effect of oral administration was unclear. There was no difference between groups for secondary outcomes overall. The quality of evidence was deemed to be low overall because of high risk of bias and imprecision in outcome measures. This review found low to moderate certainty evidence that prophylactic ondansetron reduces KAV incidence. Methodologically rigorous research, with appropriately timed prophylactic ondansetron based on the route of administration, would further elucidate prophylactic oral ondansetron's efficacy.

The prophylactic antiemetic therapies in management of differentiated thyroid cancer patients with radioactive iodine therapy: a single-center, non-randomized clinical trial.

The present study was to investigate three different single-drug regimens to show which was more effective to reduce radioactive iodine therapy (RAI) associated nausea and vomiting, and to compare the occurrence of long-term gastrointestinal diseases after RAI therapy. We performed a single-center, non-randomized clinical trial among patients who underwent RAI therapy from March 2016 to July 2022. Enrolled patients were divided into four cohorts based on the date of the treatment. cohort 1, with no preventive antiemetics; cohort 2, received 20 mg of pantoprazole per day for 3 days; cohort 3, received a 10 mg metoclopramide tablet two times daily for 3 days; cohort 4, oral ondansetron, 8 mg, twice daily for 3 days. The primary endpoints were proportion of patients who experience vomiting episodes and nausea during the 7-day hospital period. Secondary end points included Functional Living Index Emesis (FLIE) quality-of life questionnaires and the occurrence of gastrointestinal diseases. A total of 1755 patients were analyzed, comprised of 1299 (74.0%) women and 456 (26.0%) men, with a median age of 44 years (range 18-78 years). The characteristics of patient were similar within the four groups. 465 (26.4%) patients developed RAI-associated nausea, and 186 (14.4%) patients developed RAI-associated vomiting. The rate of nausea was significantly decreased in the patients who were taking ondansetron when compared with the other cohorts (P<0.05), while the rate of vomiting (≥6 episodes) was slightly lower. As secondary endpoint, FLIE measures ondansetron scored highly compared to other cohorts, from baseline (mean score of 110.53 ± 17.54) to day 7 (mean score of 105.56 ± 12.48). In addition, 48 (2.7%) patients were found to be with gastrointestinal diseases at the end of one year follow up. Multiple RAI therapy and higher dose of I-131 per body weight revealed a significantly independent risk factors of developing gastrointestinal disorders. In conclusion, the present study demonstrated that short-term ondansetron could be an effective prophylactic agent in controlling RAI-associated nausea and vomiting. Furthermore, the risk of developing gastrointestinal disorders was significantly higher for patients with multiple RAI therapy and higher dose of I-131 per body weight.

Comparative Analysis of Oral Ondansetron, Metoclopramide, and Domperidone for Managing Vomiting in Children With Acute Gastroenteritis.

Background Acute gastroenteritis (AGE) is a major health concern in pediatric populations because of its associated vomiting, which worsens dehydration and the severity of illness. Objective The purpose of the research was to compare the relative effectiveness of oral ondansetron in treating AGE in children's vomiting when compared to oral domperidone and oral metoclopramide. Methodology A clinical investigation involving 120 pediatric patients diagnosed with AGE was conducted in Pakistan from November 2022 to April 2023 using a single-blindrandomized design and convenience sampling. Theparticipants received oral suspensions of ondansetron, metoclopramide, and domperidone, with doses of 0.15 mg/kg, 0.1-0.2 mg/kg, and 0.5 mg/kg, respectively, adjusted according to their body weight. The outcomein different groups was analyzed using the Statistical Package for the Social Sciences (SPSS) (version 20.0; IBM SPSS Statistics for Windows, Armonk, NY). Results At six hours, vomiting cessation rates were 80.0% for ondansetron (n=32), 72.5% for domperidone (n=29), and 67.5% for metoclopramide (n=27; p=0.29). By 24 hours, ondansetron exhibited significantly higher efficacy (92.5%; n=37) compared to domperidone (82.5%; n=33) and metoclopramide (77.5%; n=31; p=0.03). Adverse effects were minimal and comparable across groups. Conclusion Oral ondansetron demonstrated superior efficacy in managing AGE-related vomiting in children within 24 hours compared to metoclopramide and domperidone.

Isopropyl alcohol inhalation for the treatment of nausea in adult emergency department patients: a systematic review and meta-analysis

BackgroundNausea and vomiting is a common ED chief complaint. However, randomised trials comparing antiemetic agents to placebo have not demonstrated superiority. This systematic review investigates the efficacy of inhaled isopropyl...

Ondansetron Safety Regarding Prolong QTc for Children with Head Trauma

BackgroundThere have been recent reports of increased QT interval after head trauma in concussed athletes and adult patients. Ondansetron, which is widely used in treatment of nausea and vomiting symptoms in head injuries, was issued a safety warning from the U.S. Food and Drug Administration regarding QT prolongation and risk of fatal dysrhythmias. ObjectiveThe purpose of this study was to evaluate the safety of ondansetron regarding QT prolongation for patients experiencing nausea or vomiting after head trauma. MethodsPatients aged 1–20 years presenting to a pediatric emergency department with head trauma and who required a dose of ondansetron for nausea or vomiting were enrolled in the study. Patients received a baseline 12-lead electrocardiogram (ECG) prior to administration of either oral or IV ondansetron. A second post-ondansetron 12-lead ECG was performed after administration of ondansetron. All ECGs were reviewed and the QTc calculated manually by a board-certified pediatric cardiologist. ResultsForty-two patients met enrollment criteria. Five patients received IV ondansetron and 37 received oral ondansetron. Mean QTc pre ondansetron was 387.5 ms and mean QTc post ondansetron was 400.9 ms (p = 0.120). We found no statistically significant difference in other ECG parameters pre and post ondansetron. ConclusionsOndansetron is safe in regard to QTc prolongation in patients with head trauma. Based on this research, ondansetron should continue to be used for the treatment of nausea and vomiting in emergency department patients who present with head injury.

Effectiveness of Ondansetron in comparison to Domperidone for treating vomiting in acute gastroenteritis among children in a tertiary care hospital setting: A quasi-experimental study

BACKGROUND &amp; OBJECTIVE: There is inconsistent evidence on using antiemetic drugs (ondansetron and domperidone) in children with vomiting associated with gastroenteritis having dehydration. The study's objective was to compare the effectiveness of oral domperidone with ondansetron for treating vomiting during acute gastroenteritis in children with either mild or moderate dehydration.&#x0D; METHODOLOGY: This non-controlled quasi-experimental study was conducted at Allama Iqbal Teaching Hospital, Sialkot, in the department of Pediatrics from 1st October 2019 to 31st December 2019. Sixty children aged 1-12 years having acute gastroenteritis, with mild or moderate dehydration after the failure of initial oral rehydration therapy, were included. Children in-group A (n=30) received a single dose of an orally disintegrating tablet of ondansetron, and children in-group B (n=30) were treated with domperidone. The absence of vomiting for 6 hours and subsequent successful rehydration in these two groups was the primary outcome. The Chi-square test was applied to compare the frequency of primary outcome between the ondansetron and domperidone groups, considering p-value ≤0.05 was considered statistically significant.&#x0D; RESULTS: The mean age of patients was 4.4±1.8 years in group A compared to 5.1±2.7 years in group B. Oral Ondansetron was successful in controlling vomiting in 19(63.4%) patients compared to 11(36.6%) in domperidone group (p=0.39).&#x0D; CONCLUSION: The single dose of oral ondansetron compared to domperidone was significantly effective in controlling the vomiting in-patient with acute gastroenteritis presented with either mild or moderate dehydration, resulting in effective oral rehydration subsequently.

Diagnosis of Serious Conditions Delayed in Association with Ondansetron Treatment for Vomiting in the Pediatric Emergency Department.

We evaluated the characteristics and sought risk factors for hospitalization in children who return to the emergency department within 7 days of discharge after oral or intravenous ondansetron treatment for vomiting. The secondary aim was to determine whether the diagnosis of any serious condition had been delayed as the result of discharge after ondansetron treatment. This retrospective analysis of the medical records of children who had been treated for vomiting with ondansetron in a tertiary care pediatric emergency department and revisited the emergency department within 7 days was performed between 2017 and 2019. We compared demographic and clinical features as well as management between hospitalized and discharged patients, focusing upon potentially delayed diagnoses of serious conditions. Fifty of the 89 ondansetron-treated children (56.2%) who revisited the emergency department were discharged home after their second emergency department visit and the remaining 39 (43.8%) were hospitalized. No parameter of the management of the first visit was predictive of the outcome of the revisit. Five revisit patients (5.6%) were newly diagnosed with a serious condition, with intussusception and ovarian torsion being the most substantial time-sensitive delays (the other diagnoses were pneumonia and aseptic meningitis). Physicians assessing patients who had been treated with ondansetron as supportive care for vomiting at an earlier visit to the pediatric emergency department should consider alternative diagnoses despite initial clinical improvement. No definitive risk factor for readmission was identified, but a high level of alertness to a possible meningeal or acute abdominal source is imperative.

Intranasal ondansetron microemulsion counteracting the adverse effects of cisplatin: animal study

BackgroundCisplatin is considered one of the most effective and commonly used chemotherapeutic drugs, but despite its high therapeutic effectiveness, most patients treated with cisplatin suffer from nausea and vomiting, neurotoxic side effects, and cerebral psychiatric disorders such as depression. Therefore, the aim of the current work was to explore whether a selective 5-HT3 receptor antagonist (Ondansetron) administered via the oral route or intranasally in microemulsion form would alleviate cisplatin’s adverse effects.MethodsThe selected ondansetron microemulsion was characterized in vitro for particle size, polydispersity, zeta potential, morphology, and nasal permeation, and in vivo in terms of anti-emetic and antidepressant activity, with the assessment of biochemical markers in brain homogenates.ResultsResults revealed that both orally administered ondansetron and intranasally administered microemulsion were able to counteract the pica effect by increasing food consumption, water intake, and decreasing kaolin intake. They were also able to increase BDNF, normalize IL-6, increase serotonin, and normalize NOx, MDA, GSSH/GSH as well as 8OHdG levels in rats’ brain homogenates. The intranasal ondansetron microemulsion displayed superiority compared to oral conventional ondansetron in terms of increasing food intake, reduction of stomach content, and normalization of serotonin turnover.ConclusionOndansetron microemulsion can be administered by an alternative route of administration (intranasal) rather than oral, for patients on cisplatin chemotherapy.Graphical

Phase 1b study of weekly split-dose selinexor in soft tissue sarcoma (STS).

11563 Background: Selinexor has demonstrated clinical activity in a variety of tumors including STS. Selinexor dosing at 60mg twice a week or 80mg once a week in later phase trials was associated with gastrointestinal and hematologic toxicities requiring frequent dose interruption and reduction. Preclinical in vivo studies show that selinexor use in a split-dose regimen or sustained-release formula is associated with less toxicity. This phase 1b study aimed to evaluate the safety and tolerability of split-dose selinexor in patients (pts) with advanced STS. Methods: Eligible pts with advanced STS of any histologic subtype, and ECOG performance status (PS) ≤ 1 were treated with split-dose selinexor (40mg, 20mg, 20mg in the morning, afternoon, and evening, respectively) on days 1, 8, 15 and 22 of a 28-day cycle, until unacceptable toxicity or disease progression. Antiemetic prophylaxis (oral dexamethasone and ondansetron) was given to all pts. The primary endpoint was the rate of grade ≥ 3 treatment-related adverse events (TRAE) by CTCAE v5.0. The secondary endpoint was assessment of quality of life (QoL) using the EORTC QLQ-c30 tool v3. Descriptive analyses of Global Health Status (GHS) QoL scores at screening (baseline) and cycle 2 day 1 (C2D1) were performed. Radiologic tumor assessments (by RECIST v1.1) were performed every 8 weeks while on treatment. Results: Nineteen pts [12 female and 7 male; ECOG 0/1, 8/11; median age 61 years (range 41 – 83)] were enrolled. The most frequent of 12 STS subtypes was leiomyosarcoma (n = 7, 37%). Among 18 patients evaluable for toxicity, there were no grade ≥ 3 TRAE. The most common grade ≤ 2 TRAE were dysgeusia (n = 11, 61%), nausea (n = 11, 61%), fatigue (n = 10, 56%) and vomiting (n = 10, 56%). Grade ≤ 2 hematologic TRAE were thrombocytopenia (n = 6, 33%), neutropenia (n = 4, 22%) and anemia (n = 1, 6%). Dose reduction was required in 3 pts (17%) due to intolerable grade 2 TRAE (fatigue, nausea, thrombocytopenia). No serious adverse event due to selinexor was noted. QoL scores were evaluable for 15 pts. The mean (± SEM) change in GHS QoL score from baseline to C2D1 was -10.6 (± 4.8). Among 16 pts evaluable for radiologic response, the best response was stable disease (SD) in 10 pts (63%), and progressive disease (PD) in 6 pts (37%). Durable clinical benefit (SD for &gt; 16 weeks) was seen in 5 pts (31%; 95%CI 11.0 – 58.7%) The median PFS was 3.6 months (95%CI 1.7 – 7.3). Conclusions: Split-dose selinexor was well tolerated in this heterogeneous group of pts with advanced STS and warrants further interrogation. Updated toxicity, safety, efficacy and QoL data will be presented at the meeting. Clinical trial information: NCT04811196.

Oral Ondansetron Reduces IV Fluid Use in the Emergency Department

Oral Ondansetron Reduces IV Fluid Use in the Emergency Department

Ondansetron vs Domperidone in the Treatment of Vomiting in Children with Acute Diarrhea: A Randomized, Double-Blind Study

Objective: The aim of this study is to compare the efficacy of oral ondansetron with oral domperidone in reducing vomiting in children with acute diarrhea. Study Design: Randomized control trial Place and Duration:The study was conducted atChildren Medical Center (CMC) / Dr Habibun Nabi Children Hospital, Airport Road Mingora Swat and Paediatrics department of Central Park Teaching Hospital, Lahore during the period fromJanuary 2020 to September 2020. Methods: Total one hundred and fifty children with ages 1-7 years were presented in this study. Children had diarrhea and vomiting from the last 24-48 hours. Informed written consent was taken from guardians for detailed demographics age, sex, weight, height and residency were calculated. Children were equally split into two groups. Group A received 0.15 mg/kg oral ondansetron with 75 children and group B received 0.5 mg/kg oral domperidone with 75 patients. Post treatment blockage of vomiting was observed after 12-24 hours. SPSS 24.0 version was used to analyze all data. Results: Majority of the patients were males 45 (60%) in group A and 42 (56%) in group B while rest were females 30 (40%) in group A and 33 (44%) in group B. Mean age of the patients in group A was 4.3 ±2.17 years and in group B mean age was 3.08±6.88 years. Mean weight of the patients were 15.07±8.23 kg and 15.02±3.09 kg in group A and B respectively. In group A mean height was 98.07±11.14 cm and in group B mean height was 97.67±18.24 cm. After 12 hours vomiting stopped in group A was 61 (81.3%) and 54 (72%) patients in group B. Efficacy after 24 hours were significantly higher among patients of group A in 69 (92%) children as compared to group B in 60 (80%) cases with p value &lt; 0.05. Conclusion: In this study we concluded that for reducing vomiting in children with acute diarrhea use of oral ondansetron was effective and useful as compared to oral domperidone. Keywords: Acute Diarrhea, Ondansetron, Domperidone, Vomiting

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.

The effect of oral ondansetron on QT interval in children with acute gastroenteritis; a retrospective observational study

BackgroundIn mildly to moderately dehydrated patients with acute gastroenteritis (AGE), oral rehydration therapy (ORT) is the treatment of choice. Though ondansetron is a very effective antiemetics and leads to succeed ORT, there have been reports QT prolongation in patients using it. We investigated the effect of oral ondansetron on QT interval in mildly to moderately dehydrated children with AGE.MethodsThis retrospective observational study was conducted in a single pediatric emergency department (ED) of a tertiary university hospital. We collected the medical records of patients with a primary diagnosis of AGE who received oral ondansetron and underwent an electrocardiogram between January 2017 and June 2018. A pediatric emergency physician calculated the corrected QT interval (QTc) by Bazett’s method, and the calculations were reviewed by a pediatric cardiologist. QTc values before (preQTc) and after (postQTc) ondansetron administration were analyzed. ΔQTc was calculated as the change from preQTc to postQTc. We also investigated any cardiac complications from oral ondansetron.ResultsTotal 80 patients were included. The mean age of the patients was 53.31 ± 32.42 months, and 45% were male. The mean dose of oral ondansetron was 0.18 ± 0.04 mg/kg. The mean interval from administration of ondansetron to performance of the electrocardiogram was 65 ± 26 min. The mean preQTc was 403.3 ± 24.0 ms, and the mean postQTc was 407.2 ± 26.7 ms. Two patients had a preQTc ≥460 ms, and one patient had a postQTc ≥460 ms. ΔQTc was ≥30 ms in seven patients (8.8%). No ΔQTc was ≥60 ms. No pre- or postQTc was ≥500 ms. No patient had a fatal cardiac arrhythmia after taking ondansetron.ConclusionOral administration of a single dose of ondansetron in children with AGE did not cause high-risk QTc prolongation or fatal arrhythmia.

Cost-effectiveness of oral ondansetron for children with acute gastroenteritis in primary care: a randomised controlled trial.

BackgroundAcute gastroenteritis is a common childhood condition with substantial medical and indirect costs, mostly because of referral, hospitalisation, and parental absence from work.AimTo determine the cost-effectiveness of adding oral ondansetron to care as usual (CAU) for children with acute gastroenteritis presenting to out-of-hours primary care (OOH-PC).Design and settingA pragmatic randomised controlled trial from December 2015 to January 2018, at three OOHPC centres in the north of the Netherlands (Groningen, Zwolle, and Assen) with a follow-up of 7 days.MethodChildren were recruited at the OOH-PC and parents kept a parental diary. Inclusion criteria were: aged 6 months–6 years; diagnosis of acute gastroenteritis; at least four reported episodes of vomiting 24 hours before presentation, at least one of which was in the 4 hours before presentation; and written informed consent from both parents. Children were randomly allocated at a 1:1 ratio to either CAU (oral rehydration therapy) or CAU plus one dose of 0.1 mg/kg oral ondansetron.ResultsIn total, 194 children were included for randomisation. One dose of oral ondansetron decreased the proportion of children who continued vomiting within the first 4 hours from 42.9% to 19.5%, (a decrease of 54.5%), with an odds ratio of 0.4 (95% confidence interval [CI] = 0.2 to 0.7; number needed to treat: four). Total mean costs in the ondansetron group were 31.2% lower (€488 [£420] versus €709 [£610]), and the total incremental mean costs for an additional child free of vomiting in the first 4 hours was −€9 (£8) (95% CI = −€41 [£35] to €3 [£3]).ConclusionA single oral dose of ondansetron for children with acute gastroenteritis, given in OOH-PC settings, is both clinically beneficial and cost-effective.

Oral Ondansetron Administration in Children Seeking Emergency Department Care for Acute Gastroenteritis: A Patient-Level Propensity-Matched Analysis

This study aimed to explore oral ondansetron usage and impact on outcomes in clinical practice. This observational study was a planned secondary analysis of 2 trials conducted in 10 US and 6 Canadian institutions between 2014 and 2017. Children 3 to 48 months old with gastroenteritis and ≥3 episodes of vomiting in the 24 hours preceding emergency department (ED) presentation were included. Oral ondansetron was administered at the discretion of the provider. The principal outcomes were intravenous fluid administration and hospitalization at the index visit and during the subsequent 72 hours and diarrhea and vomiting frequency during the 24 hours following the ED visit. In total, 794 children were included. The median age was 16.0 months (interquartile range 10.0 to 26.0), and 50.1% (398/794) received oral ondansetron. In propensity-adjusted analysis (n=528), children administered oral ondansetron were less likely to receive intravenous fluids at the index visit (adjusted odds ratio [aOR] 0.50; 95% confidence interval [CI] 0.29 to 0.88). There were no differences in the frequencies of intravenous fluid administration within the first 72 hours (aOR 0.65; 95% CI 0.39 to 1.10) or hospitalization at the index visit (aOR 0.31; 95% CI 0.09 to 1.10) or the subsequent 72 hours (aOR 0.52; 95% CI 0.21 to 1.28). Episodes of vomiting (aRR 0.86; 95% CI 0.63 to 1.19) and diarrhea (aRR 1.11; 95% CI 0.93 to 1.32) during the 24 hours following ED discharge also did not differ. Among preschool-aged children with gastroenteritis seeking ED care, oral ondansetron administration was associated with a reduction in index ED visit intravenous fluid administration; it was not associated with intravenous fluids administered within 72 hours, hospitalization, or vomiting and diarrhea in the 24 hours following discharge.