The present guidelines are the most recent data on postoperative nausea and vomiting (PONV) and an update on the 2 previous sets of guidelines published in 2003 and 2007. These guidelines were compiled by a multidisciplinary international panel of individuals with interest and expertise in PONV under the auspices of the Society for Ambulatory Anesthesia. The panel members critically and systematically evaluated the current medical literature on PONV to provide an evidence-based reference tool for the management of adults and children who are undergoing surgery and are at increased risk for PONV. These guidelines identify patients at risk for PONV in adults and children; recommend approaches for reducing baseline risks for PONV; identify the most effective antiemetic single therapy and combination therapy regimens for PONV prophylaxis, including nonpharmacologic approaches; recommend strategies for treatment of PONV when it occurs; provide an algorithm for the management of individuals at increased risk for PONV as well as steps to ensure PONV prevention and treatment are implemented in the clinical setting.

/pdf/consensus-guidelines-for-the-management-of-postoperative-2nf0ld87bn.pdf

Consensus Guidelines for the Management of Postoperative Nausea and Vomiting

A drug is granted a license for use after a thorough assessment of risks and benefits based on high-quality scientific proof of its efficacy and safety. Many drugs that are relevant to children are not licensed for use in this population implying that a thorough assessment of risks and benefits in the pediatric population has not been made at all, implying a negative risk-benefit balance in children, or implying insufficient information to establish the risk-benefit balance. Use of drugs without positive assessment of risks and benefits exposes children to potential lack of efficacy, unknown toxicity, and harm. To aid guideline committees and individual prescribers, we here present a tutorial of the Benefit and Risk Assessment for Off-label use (BRAvO) decision framework. This pragmatic framework offers a structured assessment of benefits and risks of off-label drug use, including a clinical pharmacological based approach to age-appropriate dose selection. As proof of concept and to illustrate the practical use, we have applied the framework to assess benefits and risks of off-label use of ondansetron for gastroenteritis-induced nausea and vomiting. The framework could also guide decisions on off-label use in other special populations (e.g., pregnant women, elderly, obese, or critically ill patients) where off-label drug use is frequent, thereby contributing to effective and safe pharmacotherapy.

Benefit-Risk Assessment of Off-Label Drug Use in Children: The Bravo Framework

Introduction: Postoperative nausea and vomiting (PONV) is associated with poor patient satisfaction and delayed recovery after general anesthesia. Multiple neurotransmitters are involved in the mediation of PONV but despite the introduction of new antiemetics, no completely effective drug exists for its prevention or treatment. Areas covered: This review provides a detailed description of ondansetron's chemistry, pharmacokinetics, pharmacodynamics, toxicity and a brief review of clinical trials involving ondansetron and the management of PONV. We searched reviews, meta-analysis and randomized controlled trials (Medline, Embase and article reference lists). Expert opinion: According to current literature, administering ondansetron 4 mg i.v. near the end of surgery provides sufficient protection against PONV in low- and moderate-risk patients, comparable to traditional antiemetics such as antihistamines and droperidol. High-risk patients require a multimodal approach since one quarter of them will not respo...

Ondansetron: a review of pharmacokinetics and clinical experience in postoperative nausea and vomiting

Introduction Ondansetron is commonly used to treat vomiting in gastroenteritis, but has a United States Food and Drug Administration black box warning for risk of Q wave to T wave time interval (QT) prolongation. We report 2 pediatric cases of fatal refractory cardiac arrest after administration of ondansetron. Cases A 10-year-old previously healthy boy presented to the emergency room with gastroenteritis symptoms. After intravenous fluids, morphine, antibiotics, and 2 doses of ondansetron, the patient became unresponsive with agonal respirations and a wide complex tachycardia consistent with ventricular tachycardia. In a second case, an 86-day-old infant with previously unidentified congenital cardiomyopathy presented to our emergency department with gastroenteritis symptoms. The patient received ondansetron and subsequently experienced repeated bouts of supraventricular tachycardia which progressed to ventricular fibrillation. Resuscitation efforts failed in each case, and both patients expired. Discussion Ondansetron can cause dose-dependent QT prolongation effects, which are more clinically relevant when other proarrhythmic elements are present. There is very limited published experience on use of ondansetron in children younger than 2 years. Our 2 cases join 2 previous case reports of death after ondansetron administration for gastroenteritis. The pharmacology of ondansetron's cardiac effects and drug-induced QT prolongation is discussed. Conclusions Patients may have hidden risk factors that, together with ondansetron, could result in a proarrhythmic state that could lead to adverse effects, such as arrhythmias. Administration of ondansetron should be individualized and used cautiously in patients with risk factors for arrhythmia.

Fatal Cardiac Arrest in 2 Children: Possible Role of Ondansetron.

An update on the management of PONV in a pediatric patient.

Purpose
Until recently, ondansetron was approved for the prevention of nausea and vomiting only in patients older than 2 years. However, as the use of ondansetron in patients younger than 2 years had been documented, characterization of ondansetron pharmacokinetics in this younger pediatric age group was warranted.

Population pharmacokinetics of intravenous ondansetron in oncology and surgical patients aged 1−48 months

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Population pharmacokinetics of intravenous ondansetron in oncology and surgical patients aged 1−48 months