Accuracy of dispersing tramadol capsules for oral administration in young children

Area of Science:

• Pediatric Pharmacology
• Pain Management
• Pharmaceutical Compounding

Background:

• Oral tramadol drops (100 mg/ml) are used for pediatric analgesia, especially post-adenotonsillectomy.
• The Australian Therapeutic Goods Administration advises against tramadol drops in children under 12 due to overdose risks.
• A 50 mg tramadol capsule is the only alternative preparation for smaller pediatric doses.

Purpose of the Study:

• To assess the accuracy and safety of preparing pediatric tramadol doses from 50 mg capsules.
• To evaluate an alternative method for tramadol administration in children under 12 years.

Main Methods:

• Twenty surgical ward nurses were tasked with preparing a 15 mg tramadol dose from a 50 mg capsule.
• The accuracy of the prepared doses was measured against the target 15 mg dose.

Main Results:

• Doses were within ±5% of 15 mg in 65% of preparations (13/20 nurses).
• Doses were within ±10% of 15 mg in 95% of preparations (19/20 nurses).
• The range of prepared doses was 13.9-17.1 mg, considered clinically acceptable and safe.

Conclusions:

• Preparing tramadol doses by dispersing 50 mg capsules is sufficiently accurate for clinical pediatric use.
• This method is considered safe, with dose variability unlikely to cause significant toxicity.
• The maximum dose administered is limited by the capsule strength (50 mg), enhancing safety.