1. Susman, Ed

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PALM SPRINGS, Calif.-Children with chronic pain appear to be able to switch from opioids to twice-daily oxycodone controlled-release tablets, researchers reported here at the American Pain Society Annual Scientific Meeting.

Figure. Oxycodone... - Click to enlarge in new windowFigure. Oxycodone

A total of 107 of the 155 patients aged six to 16 were assessed as being "very much" or "much" improved by their caregivers after being switched to oxycodone.


The study was sponsored by Purdue Pharma, with the company's medical liaison, Stacy Baldridge, RN, MSN, reporting the results in a poster study.


Another 17 patients were judged to be minimally improved, and the caregivers said that for the rest of the patients evaluated after four weeks of therapy there was no change in their condition. And in one child the treatment appeared to worsen the pain, and in another two the pain was considered to be very much worse. About 25 percent of the children in the study had cancer-related pain, and the others had pain related to other conditions.


"Chronic pain in children is the result of biological, psychological, developmental, and sociocultural factors, and includes persistent and chronic pain," Baldridge said. "Only a small number of analgesics have been studied in children. Data on oxycodone in children are limited, and the safety and efficacy of oxycodone hydrochloride controlled-release tablets have not been established in children below the age of 18."

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'Effective & Reasonable Alternative to Morphine'

Asked for his perspective for this article, James Cleary, MBBS, Director of the Pain and Policy Studies Group at the University of Wisconsin, Madison, who was not involved with the study, said: "We know that there is a global under-treatment of children with cancer with pain. There are a number of reasons why, and one of those reasons is the formulation issue.


"In the U.S., we have treatment solutions available, but that is not the case in the rest of the world. This study shows that oxycodone is an effective and reasonable treatment for children instead of morphine for pain relief. Despite what has been said about [Purdue Pharma] in the media, I think the company is being reasonable in doing the appropriate studies in children."


There have been very few studies looking at the pharmacokinetics and tolerability of these medicines in children, Cleary continued. "If we look at U.S. studies for pediatric pain relief, the guidelines recommend that we not use codeine, yet if you look at the most common medicine used in children it is actually codeine. The World Health Organization has taken codeine out of the guidelines for treatment of persistent pain in children."


'Need Pain-Registration Studies'

He said companies should be doing appropriate pain registration studies, looking at the specific kinetics in children. "In this study the researchers have taken children who were relatively tolerant of opioids and put them on twice-a-day Oxycontin. This is not to say we should be starting children on Oxycontin, but the study does discuss dosing by weight and appears to be following all the appropriate pharmacological guidelines."


Cleary noted that in treating adults for persistent pain, doctors will often switch medicines, since at some point drugs may lose effectiveness. "It is beneficial to have the safety record of a new medicine for children-I think it is great to have this new information."


He said that the pediatric cancer pain population is small, "but like any population we need to do more to relieve the suffering of this population."