From the Research
Intravenous (IV) diclofenac should be used with caution in children, as it is not FDA-approved for pediatric use in the United States, and its safety profile is not well-established in this population. When considering the use of IV diclofenac in children, it is essential to weigh the potential benefits against the risks, including increased risk of gastrointestinal bleeding, renal impairment, and cardiovascular events compared to other pain management options for children 1.
Key Considerations
- The medication should be administered slowly over 15-30 minutes to minimize adverse effects.
- Dosing is typically calculated at 0.3-1 mg/kg every 8 hours, not exceeding 3 mg/kg/day or 150 mg total daily dose.
- Alternative pain management strategies like acetaminophen, ibuprofen oral formulations, or opioids are generally preferred in pediatric patients.
- If IV diclofenac must be used, it should be for the shortest duration possible with careful monitoring of renal function, gastrointestinal symptoms, and cardiovascular parameters.
Safety Profile
- Serious adverse reactions occurred in fewer than 0.24% of children treated for acute pain with diclofenac 1.
- The types of serious adverse reactions were similar to those reported in adults.
- There is a risk of injection site reactions, and the medication should be used with caution in children with liver dysfunction, impaired renal function, hypovolemia or hypotension, coagulation disorders, thrombocytopenia, or active bleeding from any cause 2.
Pharmacokinetics
- A pharmacokinetic meta-analysis has been undertaken to recommend a dose for children aged 1-12 years, and the results suggest that single doses of 0.3 mg·kg(-1) for intravenous diclofenac in children aged 1-12 years are recommended as they yield a similar area under the diclofenac concentration-time curve (AUC) to 50 mg in adults 3.
- The formation clearance of the active metabolite 4'-hydroxydiclofenac contributed 19% of total clearance (44.82 l.h(-1) 70 kg(-1)) 4.