Please confirm that an ethics committee approval has been applied for or granted: Not relevant

Background and Aims The management of post-operative pain is essential to ensure patient comfort and timely recovery following surgery. Paracetamol and ibuprofen are the recommended analgesics for post operative pain at our tertiary paediatric hospital. Paediatric patients rely on their guardians for the correct administration of their pain relief. Unfortunately, poor literacy skills may lead to guardians not understanding the patient information leaflets (PIL) provided with medications. The literature suggests that health information should be pitched at a reading age level of 11-13 years of age.

Methods The ”Health Products Regulatory Authority” database was searched for paracetamol and ibuprofen products that were suitable for children. The registered PIL from these products were entered into a readability tool. Five of the tests compared the readability to an American school grade while one of the tests (FRE) rated the readability on a numerical scale. The corresponding cut off for a reading age of 11-13 was a grade of ≤ 7 or >70 for the FRE score.

Results 31 products met our criteria. 14(45%) were paracetamol and 17(55%) were ibuprofen products. The mean grade of all tests were >7 (range 10.95 - 13.56) and mean of FRE was <70 (mean 43.48).

Conclusions Using standardised readability tests, all PIL were above the recommended reading age for medical information. This may affect a guardian’s ability to provide appropriate pain relief for children following surgery. Pharmaceutical companies should ensure that PIL are at the recommended reading level to prevent incorrect dosing of pain relief which may lead to pain and patient harm.