Clinical trials: the viewpoint of children with a chronic illness compared with healthy children.

The views of over 200 children (11-16 years old, who were either healthy or attending paediatric medical clinics with a chronic illness) on issues relating to paediatric clinical trials were determined by a questionnaire. Children with a chronic illness had a better understanding of the concept of dosing of medicines (40% vs 23%) and placebo (34% vs 20%). They were more likely to support children's involvement in clinical trials (51% vs 37%). The altruistic nature of children in both groups was similar. It was of concern, however, that 57-63% children would participate as healthy volunteers in a cancer drug trial. Both groups were able to differentiate between the different types of illnesses where it is appropriate to study medicines in children (86-89% for illness where there is no treatment; 34-40% for 'me-too' drugs). Young people should be given more opportunities to be involved in decision-making regarding clinical trials of medicines.

A randomised controlled trial to compare postoperative pain in children undergoing tonsillectomy using cold steel dissection with bipolar haemostasis versus coblation technique.

OBJECTIVE: To measure postoperative pain levels in children undergoing tonsillectomy, by two different techniques, cold steel dissection and coblator dissection. The hypothesis - that coblator dissection may be associated with less postoperative pain. DESIGN: Prospective, randomised, double blind trial. SETTING: Single centre, secondary care Children's Hospital. PARTICIPANTS: Children aged between 4 and 16 years, undergoing tonsillectomy, or adeno-tonsillectomy. EXCLUSION CRITERIA: children already taking regular analgesia and those who experienced postoperative bleeding. Seventy-nine children were recruited, nine were excluded. MAIN OUTCOME MEASURES: We compared analgesia requirements during the first 10 days, and also the return to normal eating and drinking. These were assessed, using a validated pain scale. All analgesic administration in hospital and at home was compared. The return to normal eating & drinking patterns, was also compared. RESULTS: Whilst in the 24 h postoperatively there was no significant difference in the pain scores between the two groups, the coblator group required less potent analgesia. No statistical difference was identified between the two groups following discharge, except on the sixth postoperative day, when the coblator group had lower pain scores. This may represent chance, rather than a clear difference. CONCLUSION: The findings do not confirm the hypothesis that tonsillectomy undertaken in children, with the coblator device, is associated with lower levels of postoperative pain, but do indicate that less analgesia is required by the coblator patients in the first 12 h postoperatively.

Clinical trials: the viewpoint of children.

The views of 30 children (8-16 years old) attending paediatric medical clinics on paediatric clinical trials were determined by semi-structured interviews. Nineteen children recognised that there were risks involved with taking part in clinical trials. Risks concerned with being paid were recognised by all children.