What is the dose of Ondansetron (Zofran) for pediatric patients?

From the Guidelines

The recommended dose of Ondansetron (Zofran) for pediatric patients is 0.15 mg kg-1 every 8 hours. This dosage suggestion is based on the most recent guidance from the European Society for Paediatric Anaesthesiology (ESPA) pain management ladder initiative, as outlined in the 2024 study published in the journal Anaesthesia 1.

Key Considerations

• The dose is calculated based on the child's weight, with a recommended dosage of 0.15 mg kg-1 every 8 hours.
• It is essential to note that this dosage should not be combined with tramadol and is not recommended for children under 1 year old.
• The medication is available in various forms, including tablets, orally disintegrating tablets, and liquid form, which can be administered as needed for nausea and vomiting.

Administration and Monitoring

• The dosage frequency of every 8 hours is crucial to ensure effective management of nausea and vomiting in pediatric patients.
• As with any medication, it is essential to monitor the child for potential side effects, such as headache, constipation, or drowsiness, and adjust the dosage or seek medical attention if necessary.
• Always consult with the child's healthcare provider before administering Ondansetron, as the appropriate dose can vary based on the child's specific condition, other medications they may be taking, and their medical history.

From the FDA Drug Label

An open-label, multicenter, noncomparative trial has been performed in 75 pediatric cancer patients aged 6 to 48 months receiving at least one moderately or highly emetogenic chemotherapeutic agent. ... Ondansetron Injection was administered intravenously over 15 minutes in three doses of 0. 15 mg/kg.

Three double-blind, placebo-controlled trials have been performed (one US, two foreign) in 1,049 male and female patients (aged 2 to 12 years) undergoing general anesthesia with nitrous oxide ... Patients were randomized to either single intravenous doses of ondansetron (0. 1 mg/kg for pediatric patients weighing 40 kg or less, 4 mg for pediatric patients weighing more than 40 kg) or placebo.

A double-blind, multicenter, placebo-controlled trial was conducted in 670 pediatric patients aged 1 month to 24 months who were undergoing routine surgery under general anesthesia. ... A single 0. 1-mg/kg intravenous dose of ondansetron administered within 5 minutes following induction of anesthesia was statistically significantly more effective than placebo in preventing vomiting.

One double-blind, placebo-controlled, US trial was performed in 351 male and female outpatients (aged 2 to 12 years) who received general anesthesia with nitrous oxide and no prophylactic antiemetics. ... Patients who experienced two or more emetic episodes within 2 hours following discontinuation of nitrous oxide were randomized to either single intravenous doses of ondansetron (0. 1 mg/kg for pediatric patients weighing 40 kg or less, 4 mg for pediatric patients weighing more than 40 kg) or placebo administered over at least 30 seconds.

The dose of Ondansetron (Zofran) for pediatric patients is:

• 0.15 mg/kg in three doses for pediatric cancer patients aged 6 to 48 months
• 0.1 mg/kg for pediatric patients weighing 40 kg or less, and 4 mg for pediatric patients weighing more than 40 kg, for patients undergoing general anesthesia with nitrous oxide
• 0.1 mg/kg for pediatric patients aged 1 month to 24 months undergoing routine surgery under general anesthesia 2 2

From the Research

Dosing of Ondansetron in Pediatric Patients

• The dose of ondansetron for pediatric patients varies depending on the condition being treated.
• For chemotherapy-induced nausea and vomiting, the dose is 0.15 mg/kg intravenously or orally, with a maximum dose not specified 3.
• For postoperative nausea and vomiting, the dose is 0.1 to 0.15 mg/kg intravenously or 0.1 mg/kg orally 3.
• For acute gastroenteritis, the dose is 0.1 to 0.15 mg/kg orally, with some studies using a single dose and others using multiple doses 4, 5, 6, 7.
• A study found that within the dose range of 0.13-0.26 mg/kg, higher doses of ondansetron were not superior to lower doses, nor were they associated with increased side effects in children with acute gastroenteritis 7.

Administration Routes

• Ondansetron can be administered intravenously or orally in pediatric patients.
• The oral route is commonly used for acute gastroenteritis, while the intravenous route is often used for chemotherapy-induced nausea and vomiting and postoperative nausea and vomiting.

Efficacy and Safety

• Ondansetron has been shown to be effective in preventing nausea and vomiting in pediatric patients undergoing chemotherapy, surgery, and those with acute gastroenteritis 3, 4, 5, 6.
• The safety profile of ondansetron in pediatric patients is generally favorable, with common adverse events including headache, constipation, and diarrhea 3, 4, 5, 6, 7.