by Daniel L. Millspaugh, MD
Director, Comprehensive Pain Management Program, Children’s Mercy Kansas City
The presidential election cycle is in full swing. It is not surprising then that well-intended comments can spur controversy rather than reasoned civil discourse over complex social issues. Such is the case with recent campaign trail statements about a decision by the Food and Drug Administration (FDA) to approve OxyContin® for certain children above age 11. To be fair, many disagree with the FDA’s decision for fear that it will worsen a staggering prescription opioid misuse and addiction problem. I also am gravely concerned with this problem. So, this is less political commentary than it is a call for the pediatric pain management community to inform our potential leaders and the public of the usefulness of long-acting opioids in some children. An example might be a 13-year-old severely injured in a rollover car crash with multiple broken bones requiring several surgeries who has severe persistent pain as she recovers. Her pain could be difficult to manage with an immediate-release opioid because she may be too sleepy shortly after taking a dose, but in severe pain again before the next dose. A long-acting opioid would be helpful in this situation.
It is rare for opioids to be used in children with chronic non-cancer pain, owing in part to a growing recognition that they provide limited or no pain relief in these situations, and can be associated with serious side effects, as well as a risk of tolerance, dependence and even addiction in susceptible individuals. In children with severe acute or cancer-related pain, however, opioid medications are profoundly useful, and this benefit is balanced against those risks. The National Institute on Drug Abuse has a useful presentation on tolerance, dependence and addiction. These are separate but often conflated phenomena. As noted in that presentation, people receiving morphine for pain control after surgery are unlikely to become addicted. Dependence and addiction have different underlying brain mechanisms. It also must be recognized that inadequately treated severe acute pain can not only result in needless suffering, but also poor wound healing, impaired immune function, disturbed sleep, mood alterations, prolonged hospital stays, and increased costs. Furthermore, it may progress to chronic pain.
Opioids are useful for certain children in pain, but what about long-acting formulations? When severe pain occurs around-the clock, as is often the case in cancer or post-surgical pain, it makes sense to keep the pain medicine level in the body similarly steady. Long-acting products do just that. This matching of drug dosing to pain pattern is a rational strategy that may improve pain control and patient satisfaction, as can the convenience of taking medicines less frequently. This is especially important at night, so sleep is not disrupted. Additionally, although not proven, there is a theoretical benefit to using long-acting opioids when sustained drug levels are required; a less variable drug level may be less reinforcing, and therefore less addicting.
When prescribing a medication, one must be knowledgeable about its safe and effective use. The FDA’s stated reasoning in approving OxyContin® in children down to age 11 was to provide guidance to practitioners to facilitate safe and effect prescribing. The dissemination of pediatric drug dosing information is an FDA mandate, as many drugs used in children currently lack FDA approval and therefore prescribing guidance. One additional point with regard to OxyContin® is that the current product is an abuse-deterrent formulation, which is a step in the right direction for limiting risk. Prescription monitoring programs, available in most states, may also help with this. Like many tools, long-acting opioids can be beneficial when used appropriately and devastating otherwise. Providers must be aware of the misuse and addiction potential of opioids, including long-acting versions, and take steps to understand and mitigate those risks. We must all have our eyes wide open, and be part of the solution.
Dan Millspaugh graduated from UCSF School of Medicine, completed anesthesiology residency at Stanford, pediatric anesthesiology fellowship at Seattle Children’s Hospital, and more recently completed an advanced training program in pediatric pain management at Stanford. He is currently the medical director of the Comprehensive Pain Management Program at Children’s Mercy Kansas City.