What is the recommended dose of diclofenac (Nonsteroidal Anti-Inflammatory Drug (NSAID)) suppository for pediatric patients?

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Diclofenac Suppository Dosing for Pediatric Patients

The recommended dose of diclofenac suppository for pediatric patients is 0.5-1 mg/kg every 8 hours. 1

Age-Specific Dosing Recommendations

  • For children of all ages requiring rectal administration of diclofenac, the recommended dose is 0.5-1 mg/kg every 8 hours 1
  • This dosing has been established as effective for pain management in the postoperative setting 2
  • Single doses of 0.5 mg/kg for suppositories are recommended for children aged 1-12 years to yield a similar area under the concentration-time curve (AUC) to a 50 mg dose in adults 3

Clinical Considerations

Efficacy

  • Diclofenac suppositories have demonstrated superior antipyretic effectiveness compared to paracetamol suppositories in the first hour of administration 4
  • As an NSAID, diclofenac is effective for perioperative acute pain management in children 5
  • Diclofenac probably results in less nausea and vomiting compared to opioids for postoperative pain management (moderate-certainty evidence) 2

Administration Considerations

  • Do not administer more than 150 mg per dose site 1
  • Diclofenac can be used as adjuvant therapy for pain and inflammation in children 1
  • Although diclofenac is not FDA or EMA approved for pediatric use in some regions, it can be considered at the discretion of the treating physician based on clinical experience 1

Pharmacokinetics

  • The bioavailability of diclofenac suppositories in children is approximately 0.63 3
  • Diclofenac is eliminated following biotransformation to glucoroconjugated and sulphate metabolites which are excreted in urine 6
  • Very little of the drug is eliminated unchanged 6

Safety Considerations

  • Monitor for potential bleeding complications, as diclofenac probably increases the risk of bleeding compared to opioids (moderate-certainty evidence) 2
  • Serious diclofenac adverse reactions occur in fewer than 0.24% of children treated for acute pain 5
  • The types of serious adverse reactions in children are similar to those reported in adults 5
  • No dosage adjustments are typically required for children with various disease states (such as hepatic disease) 6

Common Pitfalls and Caveats

  • Avoid using diclofenac in children with known hypersensitivity to NSAIDs 5
  • Be cautious when using in children with asthma, as more research on safety in asthmatic children is required 5
  • Consider the risk of bleeding when using diclofenac in the perioperative period, especially for surgeries where bleeding is a concern 2
  • NSAID adjuvant therapy requires an adequate trial period of at least 8 weeks for chronic conditions, given the time course to response of about 1 month 1

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Diclofenac for acute postoperative pain in children.

The Cochrane database of systematic reviews, 2023

Research

Diclofenac for acute pain in children.

The Cochrane database of systematic reviews, 2009

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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