AIM: To investigate the feasibility, and perform a pilot study, of a randomised clinical trial, investigating whether children experience less pain, fear and/or distress when they receive oral ibuprofen vs placebo before a needle is inserted in a subcutaneously implanted intravenous port.

METHODS: Twenty-three children were included consecutively and randomised to either oral ibuprofen (n = 12) 7.5 mg/kg body weight or placebo (n = 11). The child's pain, fear and distress were reported by parents, nurses and the children (if ≥7 years of age). Feasibility criteria were defined as (a) ≥4 children included/month, (b) ≥80% of eligible patients agreed to participate, (c) >90% treated according to protocol, (d) <5% missing data, (e) s-cortisol samples analysed in ≥90% of the children.

RESULTS: All feasibility criteria were met except recruitment and consent. Parents, nurses and children reported no trend of benefit of oral ibuprofen with regard to pain, fear and distress compared with placebo.

CONCLUSION: The study failed to meet important feasibility criteria and was closed due to low recruitment rate and absence of trend of effect. From this data, we cannot state that ibuprofen is not helpful in needle procedures but that it seems unlikely.