Venepuncture for blood sampling can be a distressing experience for a considerable number of children. A prospective controlled trial was conducted to compare the efficacy of a local anaesthetic (EMLA) with a combination of EMLA with self-hypnosis in the relief of venepuncture-induced pain and anxiety in 45 paediatric cancer outpatients (age 6-16years). A secondary aim of the trial was to test whether the intervention will have a beneficial effect on parents’ anxiety levels during their child’s procedure. Patients were randomized to one of three groups: local anaesthetic, local anaesthetic plus hypnosis, and local anaesthetic plus attention. Results confirmed that patients in the local anaesthetic plus hypnosis group reported less anticipatory anxiety, and less procedure-related pain and anxiety, and were rated as demonstrating less behavioural distress during the procedure than patients in the other two groups. Parents whose children were randomized to the local anaesthetic plus hypnosis condition experienced less anxiety during their child’s procedure than parents whose children had been randomized to the other two conditions. The therapeutic benefit of the brief hypnotic intervention was maintained in the follow-up. The present findings are particularly important in that this study was a randomized, controlled trial conducted in a naturalistic medical setting. In this context, convergence of subjective and objective outcomes was reached with large effect sizes that were consistently supportive of the beneficial effects of self-hypnosis, an intervention that can be easily taught to children, is noninvasive and poses minimal risk to young patients and their parents.