Two new studies are drawing attention to a sensitive topic in the pain community: Should children be given powerful and potentially addictive opioid analgesics to relieve their pain?
According to research published in Pain Management Nursing, most children in hospitals experience pain – with 40 percent rating their pain as moderate or severe. A controversial solution to that problem would be to prescribe opioid painkillers to children and a major pharmaceutical company is currently looking into that.
Purdue Pharma, the maker of OxyContin, is planning to conduct a clinical trial of 154 children between the ages of 6 and 16 who will be given two daily doses of OxyContin. All have moderate to severe pain and have already demonstrated a tolerance to opioid painkillers.
OxyContin is not approved for use by children by the Food and Drug Administration, but some doctors prescribe it off-label to their pediatric patients. 17,000 OxyContin prescriptions were written for children last year – a tiny number compared to the millions of prescriptions written for adults.
“These children have diseases such as cancer or sickle-cell anemia, post-operative pain, injuries such as severe burns causing this degree of pain,” Jim Heins, senior director for public affairs at Purdue Pharma, told the Wall Street Journal. “The studies are evaluating the safety of OxyContin tablets in these young patients and the way the drug is absorbed, broken down and eliminated to see if there are any significant differences from the way the drug is handled by adults.”
At this time, Purdue Pharma is not seeking FDA approval for OxyContin to be prescribed for children and industry observers say that may not be the company’s ultimate goal. As an incentive to conduct the pediatric study, the FDA could grant Purdue a 6-month extension on the patent for its original OxyContin formulation, which is due to expire next year.
Even just a half year extension would be lucrative for Purdue. It sold $2.8 billion worth of OxyContin in 2011.
“Whether the results are positive or negative, we (Purdue Pharma) feel it is beneficial for clinicians who are treating pediatric patients with chronic, moderate to severe pain to have access to this information in scientific publications and in the product’s label, so they can make better decisions about the care of their patients,” said Heins.
The FDA is seeking pediatric studies on hundreds of drugs already approved for adults, including other painkillers such as fentanyl, oxymorphone and pregabalin.
“I think that studying medications in children is generally a good thing and I’m glad that the FDA has tried to incentivize drug manufacturers to do more clinical trials in children because children do have a different physiology,” said Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing.
At the same time, however, Kolodny warns that opioids carry inherent risks for both adults and children. He said he would have “no problem” with opioids being used to ease the pain of dying children with life threatening diseases, but he questions whether the painkillers should be used to treat chronic pain.
“Children may be at greater risk for the development of addiction and so to use opioids long term in children, even actually short-term exposure, may be riskier in children. That doesn’t mean we shouldn’t ever use opioids in children, but it’s a reason to be more careful in our use of opioids,” Kolodny told American News Report. “In my mind, testing OxyContin on children who might have back pain, abdominal pain or chronic painful conditions such as fibromyalgia would be extremely unethical.”
Pain in Hospitalized Children
Meanwhile, a study of nearly 200 hospitalized children at Johns Hopkins Children’s Center in Baltimore found that 86 percent of them experienced pain – despite receiving appropriate and timely therapy at a facility that has specialized in pediatric pain management for over 20 years.
“This study was designed as a pulse check to gauge our own progress,” says lead investigator Lori Kozlowksi, RN, a pediatric pain specialist at Hopkins Children’s Center. “Our verdict is that while we’ve made tremendous strides, there’s still work to be done.”
Only one-third of the children in the study who were prescribed opioids “as needed” actually received the medication. The researchers recommended that around-the-clock access to pain medication should be favored over “as needed” treatment for children.
Previous studies on pediatric pain found that intense pain during infancy and childhood can make people sensitive to pain for life. Research also shows that untreated or undertreated pain can exacerbate an injury, delay healing, make people more prone to infection and increase the risk of death.
“Pain is the fifth vital sign which, together with blood pressure, heart rate, breathing and temperature, can provide important clues about a patient’s well being,” said senior investigator Constance Monitto, MD, a pediatric anesthesiologist at Hopkins Children’s Center.
The study also found that girls reported higher pain scores than boys. Older children also had higher pain scores than infants, toddlers and children with developmental disabilities.