Dataset Information

Treatment with Oral Ondansetron for Ultramarathon-Associated Nausea: The TOO FUN Study.

ABSTRACT: Nausea and vomiting are common for runners during ultramarathons and often contribute to non-finishes. We aimed to determine the efficacy of ondansetron, a commonly used antiemetic, to treat nausea and vomiting in runners during an ultramarathon. Runners who had a previous history of frequent nausea or vomiting during races and entered in 160, 80, and 55 km ultramarathons in 2018 and 2019 were randomized in a double-blind fashion to 4 mg ondansetron or placebo capsules to use if they developed nausea or vomiting during the race with the ability to take three additional doses. Study participants completed a post-race online survey to assess medication use and efficacy. Of 62 study participants, 31 took either ondansetron (20) or placebo (11). In this small study, there were no group differences in those reporting any improvement in nausea and vomiting (p = 0.26) or in the amount of improvement (p = 0.15). We found no evidence that ondansetron capsules improve nausea and vomiting during ultramarathons.

SUBMITTER: Pasternak AV

PROVIDER: S-EPMC8001581 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Treatment with Oral Ondansetron for Ultramarathon-Associated Nausea: The TOO FUN Study.

Pasternak Andrew V AV Fiore David D Islas Arthur A Toti Sarah S Hoffman Martin D MD

Sports (Basel, Switzerland) 20210303 3

Nausea and vomiting are common for runners during ultramarathons and often contribute to non-finishes. We aimed to determine the efficacy of ondansetron, a commonly used antiemetic, to treat nausea and vomiting in runners during an ultramarathon. Runners who had a previous history of frequent nausea or vomiting during races and entered in 160, 80, and 55 km ultramarathons in 2018 and 2019 were randomized in a double-blind fashion to 4 mg ondansetron or placebo capsules to use if they developed n ...[more]

PMID: 33802399

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Project description:BackgroundThis study compared palonosetron and ondansetron as rescue medications for postoperative nausea and vomiting (PONV) in patients who received prophylactic ondansetron. Although guidelines recommend use of an agent from a different class when prophylaxis has failed, palonosetron has unique properties relative to other serotonin 5-HT3 receptor antagonists. Prior trials assessing its use for rescue have had conflicting results. Although palonosetron has compared favorably with ondansetron for PONV prevention, the drugs have not been compared in the rescue setting of failure of 5-HT3 receptor antagonist prophylaxis.MethodsThis was a randomized, open-label, multicenter trial comparing the efficacy and safety of intravenous palonosetron 0.075 mg and intravenous ondansetron 4 mg in patients experiencing PONV following laparoscopic abdominal or gynecological surgery despite prophylactic ondansetron.ResultsOf 239 patients screened, 220 were enrolled and 98 were treated for PONV: 48 and 50 in the palonosetron and ondansetron arms, respectively. Complete control during 72 hours after study drug administration was achieved in 25.0% of palonosetron recipients and 18.0% of ondansetron recipients (95% confidence interval [CI], -9.2, 23.3; p = 0.40). Corresponding incidences of vomiting were 29.2% for palonosetron and 48.0% for ondansetron (95% CI, -0.06, 37.7; p = 0.057), and 62.5% and 56.0% required additional rescue treatment, respectively (95% CI, -25.9, 12.9; p = 0.52). Other than a similar incidence of procedural pain in the 2 groups, the most common treatment-emergent adverse events, which were generally mild, were headache (14.6% vs 12.0%), constipation (8.3% vs 10.0%), and dizziness (6.3% vs 8.0%), for the palonosetron and ondansetron groups, respectively.ConclusionsPalonosetron and ondansetron did not show differences in the primary efficacy endpoint of CC during the 72 hours after study drug administration. There was a trend toward less emesis in the 0-72 h time period favoring palonosetron. While larger studies are needed to fully assess any clinical benefits of palonosetron to rescue patients who have failed ondansetron prophylaxis for PONV, the benefit, if any, would be limited based on this study.Trial registrationClinicalTrials.gov, NCT00967499 (Registered August 27, 2009).

Project description:Postoperative nausea and vomiting (PONV) is one of the most common adverse outcomes after strabismus surgery. The primary outcome of this prospective, randomized, double-blind study was to compare the incidences of nausea or vomiting, and patient satisfaction of ondansetron and ramosetron after strabismus surgery under general anesthesia. The secondary outcome was to investigate whether the number of involved extraocular muscles (EOMs) in strabismus surgery was related to PONV.One hundred and five patients (aged 18-60 years) undergoing strabismus surgery were allocated randomly to one of the three groups: placebo, ondansetron, or ramosetron. Patients received 2 ml placebo, 4 mg ondansetron, or 0.3 mg ramosetron at the end of surgery. Each of the three groups was subdivided into two subgroups according to the number of EOMs involved in the surgery: subgroup S, single-muscle correction; subgroup M, multiple-muscle correction. The incidences of nausea or vomiting, and patient satisfaction at 2, 24 and 48 h after surgery were analyzed as primary outcome. With regard to subgroups S and M in the placebo, ondansetron and ramosetron groups, incidences of nausea or vomiting, and patient satisfaction at 2, 24 and 48 h after surgery were analyzed as seconadary outcome.The incidence of nausea was significantly lower in the ramosetron group at 2 h (9.4 %) than in the placebo (45.2 %) and ondansetron (34.7 %) groups (P < 0.05). The incidence of nausea was also significantly lower in the ramosetron group at 24 h than in the other groups (P < 0.05). Patients in the ramosetron group were more satisfied at 2 h (8.11 ± 0.98) and 24 h (8.50 ± 0.67) after surgery than those in the other groups (P < 0.05). With regard to subgroups S and M in the placebo, ondansetron and ramosetron groups, there were no significant differences in either the incidence of nausea or patient satisfaction.Ramosetron has superior antiemetic activity to ondansetron in adult strabismus surgery patients. The number of EOMs involved in strabismus surgery was not related to the incidence of PONV.Clinical Research Information Service (CRiS) Identifier: KCT0000688 . Date of registration: 27 February 2013.

Project description:BackgroundThere are limited treatment options that clinicians can provide to children presenting to emergency departments with vomiting secondary to acute gastroenteritis. Based on evidence of effectiveness and safety, clinicians now routinely administer ondansetron in the emergency department to promote oral rehydration therapy success. However, clinicians are also increasingly providing multiple doses of ondansetron for home use, creating unquantified cost and health system resource use implications without any evidence to support this expanding practice.Methods/designDOSE-AGE is a randomized, placebo-controlled, double-blinded, six-center, pragmatic clinical trial being conducted in six Canadian pediatric emergency departments (EDs). In September 2019 the study began recruiting children aged 6 months to 18 years with a minimum of three episodes of vomiting in the 24 h preceding enrollment, <72 h of gastroenteritis symptoms and who were administered a dose of ondansetron during their ED visit. We are recruiting 1030 children (1:1 allocation via an internet-based, third-party, randomization service) to receive a 48-h supply (i.e., six doses) of ondansetron oral solution or placebo, administered on an as-needed basis. All participants, caregivers and outcome assessors will be blinded to group assignment. Outcome data will be collected by surveys administered to caregivers 24, 48 and 168 h following enrollment. The primary outcome is the development of moderate-to-severe gastroenteritis in the 7 days following the ED visit as measured by a validated clinical score (the Modified Vesikari Scale). Secondary outcomes include duration and frequency of vomiting and diarrhea, proportions of children experiencing unscheduled health care visits and intravenous rehydration, caregiver satisfaction with treatment and safety. A preplanned economic evaluation will be conducted alongside the trial.DiscussionDefinitive data are lacking to guide the clinical use of post-ED visit multidose ondansetron in children with acute gastroenteritis. Usage is increasing, despite the absence of supportive evidence. The incumbent additional costs associated with use, and potential side effects such as diarrhea and repeat visits, create an urgent need to evaluate the effect and safety of multiple doses of ondansetron in children focusing on post-emergency department visit and patient-centered outcomes.Trial registrationClinicalTrials.gov: NCT03851835. Registered on 22 February 2019.

Project description:Nausea is a subjective sensation which is difficult to measure in non-verbal species. The aims of this study were to determine the efficacy of three classes of antiemetic drugs in a novel low dose cisplatin model of nausea and vomiting and measure change in potential nausea biomarkers arginine vasopressin (AVP) and cortisol. A four period cross-over blinded study was conducted in eight healthy beagle dogs of both genders. Dogs were administered 18 mg/m2 cisplatin intravenously, followed 45 min later by a 15 min infusion of either placebo (saline) or antiemetic treatment with ondansetron (0.5 mg/kg; 5-HT3 antagonist), maropitant (1 mg/kg; NK1 antagonist) or metoclopramide (0.5 mg/kg; D2 antagonist). The number of vomits and nausea associated behaviours, scored on a visual analogue scale, were recorded every 15 min for 8 h following cisplatin administration. Plasma samples were collected to measure AVP, cortisol and antiemetic drug concentrations.The placebo treated group vomited an average number of 7 times (range 2-13). None of the dogs in either the ondansetron or maropitant treated groups vomited during the observation period. The onset of nausea-like behaviour in the placebo-treated group occurred at t3.5h and peaked at t4.75h with nausea behaviour score of 58.5 ± 4.6 mm. Ondansetron and maropitant reduced overall the area under the curve of nausea behaviour score by 90% and 25%, respectively. Metoclopramide had no effect on either vomiting or nausea. Cisplatin-induced nausea and vomiting caused concomitant increases in AVP and cortisol. In the placebo-treated group, AVP and cortisol increased from t2.5h, peaked at t5h (11.3 ± 2.9 pmol L-1 and 334.0 ± 46.7 nmol/L, respectively) and returned to baseline by t8h. AVP and cortisol increases were completely prevented by ondansetron and only partially by maropitant, while metoclopramide had no effect. The terminal half-lives (harmonic mean ± pseudo SD) for ondansetron, maropitant and metoclopramide were 1.21 ± 0.51, 5.62 ± 0.77 and 0.87 ± 0.17 h respectively.5-HT3 receptor antagonist ondansetron demonstrates the greatest anti-emetic and anti-nausea efficacy of the three drugs. AVP and cortisol appear to be selective biomarkers of nausea rather than emesis, providing a means of objectively measuring of nausea in the dog.

Dataset Information

Treatment with Oral Ondansetron for Ultramarathon-Associated Nausea: The TOO FUN Study.

Publications

Treatment with Oral Ondansetron for Ultramarathon-Associated Nausea: The TOO FUN Study.

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