Opioids in adult patients is problematic enough. In pediatric patients, the issues grow exponentially. A new study collected data on using an alternative to opioid pain management, EXPAREL, in pediatric patients. The full results came from an FDA approved Phase 3 study of EXPAREL (bupivacaine liposome injectable suspension) administered via infiltration in pediatric spine patients. Their overall conclusions were that the drug demonstrated safety and tolerability.
The study, “A multicenter study to evaluate the pharmacokinetics and safety of liposomal bupivacaine for postsurgical analgesia in pediatric patients aged 6 to less than 17 years (PLAY),” appears in the December 2021 edition of the Journal of Clinical Anesthesia.
“Traditionally, clinicians seeking pain control in pediatric patients have been forced to choose between opioids or traditional local anesthetics that require the use of cumbersome catheters or pumps to provide the duration of pain control needed in historically painful surgical procedures,” said Christopher Tirotta, M.D., chief of anesthesiology at Nicklaus Children’s Hospital, Miami, Florida, and lead author in the PLAY study. “The results from this study demonstrate the excellent safety profile of EXPAREL, which provides prolonged pain control and offers versatility of administration without many of the unwanted side effects that often come with opioids.”
This multicenter, open-label, randomized trial enrolled 98 patients to two groups: individuals aged 12 to less than 17 years and those aged 6 to less than 12 years.
According to the company, the study found that the “safety of EXPAREL was comparable to bupivacaine and consistent across treatment groups. There were no treatment-related cardiac or nervous system adverse events in the EXPAREL arm; EXPAREL was well tolerated for all age groups, with no discontinuations due to adverse events.”
“Children who undergo surgery often experience moderate to severe pain following their procedure, and unmanaged postsurgical pain frequently leads to delayed healing, prolonged length of stay, and even the development of chronic postsurgical pain,” said Roy Winston, M.D., chief medical officer at Pacira. “We are grateful for the opportunity to provide EXPAREL, the first and only FDA approved long-acting local analgesic for the pediatric population as young as age six, as a safe and effective pain management option to pediatric patients and their families.”
Dr. Tirotta explained to OTW, “The results from this study demonstrate the excellent safety profile of EXPAREL in pediatric patients. Before the approval of EXPAREL in pediatric patients ages 6-17 years, the standard of care for managing postsurgical pain in children was much shorter acting local anesthetics and opioids, which often come with severe and possibly life-threatening side effects.”
“We know that opioid use can be attributed to 50% of postsurgical respiratory failure events in children and can hinder recovery, extend hospital stay, and negatively impact both patient and parent experience. EXPAREL fulfills the urgent unmet need for opioid alternatives in this vulnerable patient population and safely provides prolonged pain control for children undergoing surgery.”
When OTW asked if there will be additional research on this, Dr. Tirotta noted, “Currently, EXPAREL is FDA-approved for patients 6 and older. I’m hopeful we will see more research in the future that looks at EXPAREL utilization in children under 6 years of age. By having more non-opioid options like EXPAREL in our pain armamentarium, we are better equipped to treat pediatric patients while reducing opioid exposure and ultimately improving outcomes.”
