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Clinical Nursing Research May 2023Ondansetron is a widely administered medication for nausea and vomiting of pregnancy. Further examination of its teratogenic capacity is necessary. This study examines...
Ondansetron is a widely administered medication for nausea and vomiting of pregnancy. Further examination of its teratogenic capacity is necessary. This study examines the association between ondansetron treatment during pregnancy and birth defects and adverse obstetric outcomes. Patient data were extracted from Clalit Health Services, Israel. A propensity-score analysis was performed matching those exposed to ondansetron with those who were not. Findings identified 774 women exposed to ondansetron, matched 1:1 with unexposed control patients. No significant differences were found between the groups for: cleft palate, cardiovascular congenital abnormalities, spina bifida occulta, preterm delivery, or small for gestational age. Ondansetron may be a useful and safe alternative as treatment for women who suffer from hyperemesis gravidarum and do not respond to other antiemetic drugs. Notwithstanding, additional prospectively designed research is needed to establish the safety of ondansetron treatment during pregnancy.
Topics: Pregnancy; Infant, Newborn; Humans; Female; Ondansetron; Antiemetics; Hyperemesis Gravidarum; Nausea
PubMed: 36912091
DOI: 10.1177/10547738231159062 -
Annals of Emergency Medicine Feb 2019
Topics: Adult; Antiemetics; Aromatherapy; Emergency Service, Hospital; Humans; Ondansetron
PubMed: 30661537
DOI: 10.1016/j.annemergmed.2018.10.014 -
Annals of the Royal College of Surgeons... Jul 2016Introduction Shivering is one of the most frequent complications of operation during the postanaesthesia period. Ondansetron has been proved to be valid in preventing... (Meta-Analysis)
Meta-Analysis Review
Introduction Shivering is one of the most frequent complications of operation during the postanaesthesia period. Ondansetron has been proved to be valid in preventing postanaesthesia shivering (PAS) in several studies. However, its efficiency and safety are still disputable. We therefore performed an updated meta-analysis of randomised controlled trials (RCTs) for evaluation and to clarify this issue. Methods A literature search using the PubMed, Embase™ and Cochrane Library databases was performed (from inception to January 2015). RCTs that evaluated the efficiency and safety of ondansetron in the prevention of PAS were included in the meta-analysis. The primary outcome measure was incidence of PAS, and secondary outcomes included subgroup analysis and the side effects of ondansetron. Results A total of 8 RCTs containing 905 subjects were identified as suitable for this review. Compared with placebo, ondansetron was associated with a significant reduction of PAS (relative risk [RR]: 0.33, 95% confidence interval [CI]: 0.19-0.58, p=0.0001) while no difference was detected between ondansetron and pethidine (RR: 0.89, 95% CI: 0.41-1.94, p=0.78). There was no significant difference between ondansetron and placebo or pethidine in terms of risk of bradycardia but ondansetron was associated with a lower risk of hypotension (RR: 0.26, 95% CI: 0.08-0.79, p=0.020) than placebo. There was no difference in hypotension when ondansetron was compared with pethidine. Conclusions Ondansetron can prevent PAS effectively and reduce the risk of hypotension.
Topics: Anesthesia Recovery Period; Humans; Hypotension; Ondansetron; Postoperative Complications; Randomized Controlled Trials as Topic; Serotonin Antagonists; Shivering
PubMed: 27138855
DOI: 10.1308/rcsann.2016.0152 -
Clinical and Experimental Allergy :... Sep 2019Food protein-induced enterocolitis syndrome (FPIES) is a non-IgE-mediated gastrointestinal food allergic disorder that has gained a major interest the past decade. FPIES... (Review)
Review
Food protein-induced enterocolitis syndrome (FPIES) is a non-IgE-mediated gastrointestinal food allergic disorder that has gained a major interest the past decade. FPIES prevalence, which still needs to be accurately determine in different populations, appears to be higher than previously thought (ie up to 0.7% in infants in the 1st year of life). FPIES to seafood in adults is also increasingly reported; limited data suggest that adult FPIES is most commonly triggered by shellfish, tends to affect females more than men, is characterized by a significant delay in diagnosis and a prolonged course. The first international consensus guidelines on diagnosis and management of FPIES have been published in 2017, proposing new diagnostic criteria as well as new criteria for a positive oral food challenge. However, there is a need to develop new biomarkers to improve the diagnosis and management of FPIES patients, and this requires a better understanding of the pathophysiology. Recently, the role of T cells has been questioned and a major role of innate immune cells has been suggested in acute FPIES. Regarding the treatment of acute FPIES reaction, ondansetron has emerged as an adjunct to intravenous rehydration in moderate-severe reactions and as a first-line treatment in mild reactions. Important information regarding the nutritional management of FPIES patients that might be complex has also been provided in the international guidelines. In this review, we discuss recent advances regarding all those different aspects.
Topics: Adult; Biomarkers; Dietary Proteins; Enterocolitis; Female; Food Hypersensitivity; Humans; Infant; Infant, Newborn; Male; Ondansetron
PubMed: 31468626
DOI: 10.1111/cea.13415 -
Anaesthesia Oct 2023Postoperative nausea or vomiting occurs in up to 40% in patients with multiple risk factors, despite prophylaxis. Olanzapine is an antipsychotic drug that is used to... (Randomized Controlled Trial)
Randomized Controlled Trial
Postoperative nausea or vomiting occurs in up to 40% in patients with multiple risk factors, despite prophylaxis. Olanzapine is an antipsychotic drug that is used to prevent nausea and vomiting in palliative care and to treat chemotherapy-induced nausea and vomiting. This study aimed to examine whether pre-operative olanzapine, as a prophylactic anti-emetic added to intra-operative dexamethasone, ondansetron and total intravenous anaesthesia, reduced the incidence of postoperative nausea or vomiting. We performed a multiply-blinded randomised controlled trial in patients aged 18-60 years with cancer at high risk of postoperative nausea or vomiting (three or four risk factors according to the Apfel criteria) plus a previous history of chemotherapy-induced nausea and vomiting. Patients were allocated at random to receive 10 mg olanzapine or placebo orally 1 h before surgery in addition to a two-drug regimen (dexamethasone and ondansetron) and propofol anaesthesia to prevent postoperative nausea or vomiting. The primary outcome was the incidence of postoperative nausea or vomiting in the first 24 h after surgery. In total, 100 patients were enrolled; 47 in the olanzapine group and 49 in the control group completed the study. The baseline characteristics of the groups were similar. The incidence of postoperative nausea or vomiting in the first 24 h after surgery was lower in the olanzapine group (12/47, 26%) than in the control group (31/49, 63%) (p = 0.008, RR 0.40 (95%CI 0.21-0.79)). Adding pre-operative oral olanzapine to intra-operative dexamethasone and ondansetron was highly effective in reducing the risk of postoperative nausea or vomiting in the first 24 hours after surgery in patients with a previous history of chemotherapy-induced nausea and vomiting and at least three Apfel risk factors for postoperative nausea or vomiting.
Topics: Humans; Antiemetics; Postoperative Nausea and Vomiting; Olanzapine; Ondansetron; Dexamethasone; Antineoplastic Agents; Double-Blind Method
PubMed: 37449978
DOI: 10.1111/anae.16081 -
Journal of Population Therapeutics and... 2022Postoperative nausea and vomiting occur in about 20-30% of women; however, some reports have estimated the rate at 70% in at-risk individuals. Gynecological and... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Postoperative nausea and vomiting occur in about 20-30% of women; however, some reports have estimated the rate at 70% in at-risk individuals. Gynecological and obstetrical operations are among the most frequent types of surgeries to be associated with nausea and vomiting postoperatively. Ondansetron and dexamethasone have been compared in a variety of studies for postoperative prophylaxis.
AIM OF THE STUDY
This study was conducted in order to compare the efficacy and safety of dexamethasone and ondansetron, alone or in combination, for prevention of postoperative nausea and vomiting in a sample of Iraqi women undergoing gynecological surgeries.
PATIENTS AND METHODS
The study was conducted in Al-Diwaniyah Province, a region belonging to the Mid-Euphrates sector of Iraq, at the Child and Maternity Teaching Hospital. The study started in June 2021 and the work with the research was accomplished in September 2022. The study included a total of 100 women undergoing different gynecological surgeries such as ovarian cystectomy, oophorectomy, ectopic pregnancy, total abdominal hysterectomy, and myomectomy. All participants involved in the study were categorized randomly into four groups, namely, dexamethasone, ondansetron, combined, and placebo groups.
RESULTS
The rates of nausea in the different groups were analyzed. The rates of nausea in dexamethasone, ondansetron, and combined groups revealed a significant decrease compared with that of placebo group (P < 0.05), and the rate was significantly lower in combined group when compared with dexamethasone and ondansetron groups (P < 0.05). The rate of nausea in combined group was significantly lower than that of dexamethasone and ondansetron groups. The rate of vomiting in combined group was significantly lower than that of placebo group and less than that of the dexamethasone group (P < 0.05).
CONCLUSION
Based on our study and previous reports, both dexamethasone and ondansetron are efficient and safe in preventing nausea and vomiting in gynecological operations; however, combination of both provides the best results.
Topics: Female; Humans; Dexamethasone; Gynecologic Surgical Procedures; Hospitals, Teaching; Ondansetron; Postoperative Nausea and Vomiting; Drug Therapy, Combination
PubMed: 36464494
DOI: 10.47750/jptcp.2022.984 -
Annals of Emergency Medicine May 2021
Topics: Cannabis; Haloperidol; Humans; Ondansetron; Syndrome; Vomiting
PubMed: 33902835
DOI: 10.1016/j.annemergmed.2020.12.018 -
Obstetrics and Gynecology May 2016The American College of Obstetricians and Gynecologists recommends early treatment of nausea and vomiting of pregnancy to stop progression to hyperemesis gravidarum....
The American College of Obstetricians and Gynecologists recommends early treatment of nausea and vomiting of pregnancy to stop progression to hyperemesis gravidarum. Nausea and vomiting and hyperemesis gravidarum typically occur during the first trimester, the sensitive time for exposure to teratogens because organogenesis is occurring in the embryo. An efficacious treatment used widely across the United States for both nausea and vomiting of pregnancy and hyperemesis gravidarum is ondansetron. Recent studies have provided conflicting findings on the safety of ondansetron during pregnancy. There are numerous limitations in the current literature on ondansetron safety including exposure to the medication is not limited to sensitive windows of organogenesis, there is a lack of information on dosing and compliance, self-reports of exposure are commonly used, an inadequate accounting exists for other factors that may explain the relationship between ondansetron exposure and the adverse outcome, and there exists a lack of biologic plausibility by which ondansetron might cause harm. It is the authors' opinion that current data do not support a reluctance to treat women with ondansetron in clinical practice.
Topics: Antiemetics; Female; Humans; Hyperemesis Gravidarum; Ondansetron; Pregnancy; Prenatal Care
PubMed: 27054931
DOI: 10.1097/AOG.0000000000001375 -
Obstetrics and Gynecology May 2016To examine the risk of birth defects in children born to women who used ondansetron early in pregnancy for nausea and vomiting of pregnancy or hyperemesis gravidarum. (Review)
Review
OBJECTIVE
To examine the risk of birth defects in children born to women who used ondansetron early in pregnancy for nausea and vomiting of pregnancy or hyperemesis gravidarum.
DATA SOURCES
PubMed, EMBASE, Cochrane, Scopus, Web of Science, Journals@Ovid Fulltext, ClinicalTrials.gov, and Google Scholar databases.
METHODS OF STUDY SELECTION
Studies were included for review if they were written in English, included a comparison population of patients not exposed to ondansetron, and reported human data, original research, exposure to ondansetron during the first trimester, and structural birth defects as an outcome.
TABULATION, INTEGRATION, AND RESULTS
A total of 423 records were identified. After accounting for duplicate records and including only relevant articles, a total of eight records met criteria for review. Data from the various studies were conflicting: whereas the three largest studies showed no increased risk of birth defects as a whole (36 malformations, 1,233 exposed compared with 141 malformations and 4,932 unexposed; 58/1,248 exposed compared with 31,357/895,770 unexposed; and 38/1,349 exposed compared with 43,620/1,500,085 unexposed; with odds ratios [ORs] of 1.12 (95% confidence interval [CI] 0.69-1.82), 1.3 [95% CI 1.0-1.7], and 0.95 [95% CI 0.72-1.26], respectively), two of these studies demonstrated a slightly increased risk of cardiac defects specifically (OR 2.0 [95% CI 1.3-3.1] and 1.62 [95% CI 1.04-2.14]), a finding that was not replicated in other studies. The most consistent association (if any) appears to be a small increase in the incidence of cardiac abnormalities, the bulk of which are septal defects.
CONCLUSION
The overall risk of birth defects associated with ondansetron exposure appears to be low. There may be a small increase in the incidence of cardiac abnormalities in ondansetron-exposed neonates. Therefore, ondansetron use for nausea and vomiting of pregnancy should be reserved for those women whose symptoms have not been adequately controlled by other methods.
Topics: Abnormalities, Drug-Induced; Antiemetics; Female; Humans; Hyperemesis Gravidarum; Infant, Newborn; Ondansetron; Pregnancy; Pregnancy Complications; Pregnancy Outcome
PubMed: 27054939
DOI: 10.1097/AOG.0000000000001388 -
BMJ Open Quality Mar 2022In paediatric patients with acute gastroenteritis (AGE), ondansetron use decreases the need for intravenous fluids, reduces hospitalisations and shortens illness...
In paediatric patients with acute gastroenteritis (AGE), ondansetron use decreases the need for intravenous fluids, reduces hospitalisations and shortens illness duration. Oral rehydration is also known to have excellent outcomes for mild to moderate dehydration secondary to AGE. Although these interventions are recommended in guidelines from international professional societies, baseline data at our clinic showed that <2% of these patients were offered ondansetron, and that few patients received appropriately detailed rehydration instructions. Therefore, we engaged residents and fellows as teachers and leaders in our university clinic's quality improvement programme to promote evidence-based practice for paediatric AGE. Our gap analysis identified opportunities for interventions including educating paediatricians and paediatrics residents on the safety and utility of the medication. We created standardised oral rehydration after-visit instructions and implemented a trainee-led educational approach that encouraged appropriate medication use. We used a follow-up survey to uncover provider concerns and tailor future interventions. The process metrics included: proportion of paediatric patients appropriately treated with ondansetron (goal of 80%), and proportion of patients given appropriate oral rehydration instructions. The outcome metric was 7-day representation rates. To achieve sustainability, we restructured our process to have senior residents take ownership of teaching and data collection. Trainee-driven interventions increased ondansetron prescription rates to a median of 66.6%. Patients prescribed ondansetron were less likely to represent to care, although representation rate was low overall. Postintervention data suggests that prescription rates decreased without continued interventions and additional systems redesign may help sustain impact.
Topics: Administration, Oral; Antiemetics; Child; Fluid Therapy; Gastroenteritis; Humans; Ondansetron; Pediatrics; Treatment Outcome
PubMed: 35347066
DOI: 10.1136/bmjoq-2021-001616