AIM: The aim was to investigate whether children experience less pain, fear and/or distress when they receive high-dose paracetamol compared with placebo, using a needle insertion in a subcutaneously implanted intravenous port as a model. METHODS: Fifty-one children ranging from 1 to 18 years of age being treated in a paediatric oncology setting were included consecutively when undergoing routine needle insertion into a subcutaneously implanted intravenous port. All children were subjected to one needle insertion following topical anaesthetic (EMLA) application in this double-blind, placebo-controlled RCT, comparing orally administered paracetamol (n = 24) 40 mg/kg body weight (max 2000 mg) with placebo (n = 27). The patients' pain, fear and distress were reported by parents, nurses and children (≥7 years of age) using 0- to 100-mm visual analogue scales (VAS). In addition, pain observation, procedure time and cortisol reduction were assessed. RESULTS: No differences between the paracetamol and the placebo group were found with respect to demographic characteristics. According to VAS reports, paracetamol did not reduce pain, fear and distress compared with placebo. Pain observation, cortisol reduction and procedure time did not differ between the study groups. CONCLUSION: Paracetamol provides no additive effect in reducing pain, fear and distress when combined with topical anaesthesia in children undergoing port needle insertion.