New data is debunking the idea use of NSAIDs slow bone fracture healing in children.
Despite implications from previous clinical studies, investigators of a recent randomized trial suggest nonsteroidal anti-inflammatory drugs (NSAIDs) do not slow bone fracture healing in children.
A trial examining the impact of ibuprofen in skeletally immature patients, results indicated ibuprofen was effective in relieving fracture pain and did not impair healing.
"The findings of this study are relevant for a wide variety of practitioners," said study investigator Sumit Gupta, MD, associate professor of orthopedic surgery at the University of Missouri School of Medicine, in a statement. "I think this study will be especially important when the patient first presents to the emergency department. The physician there should feel comfortable prescribing ibuprofen in addition to acetaminophen as a safe and effective pain reliever that won't hinder a child's bone healing.”
To more fully understand the impact of NSAIDs on fracture healing, Gupta and a team of colleagues from the University of Missouri Health System designed their study as a prospective, randomized, parallel, single-blinded trial. For the purpose of the study, patients were randomized to 1 of 2 groups with the goal of enrolling 50 patient s per group.
For inclusion in the study, patients needed to be screened in the clinic or emergency department between February 2014-September 2016, Mae individuals were required to be 16 years or young, female individuals were required to 14 years of age or younger, have open physis on radiographs, and a long bone fracture. Patients were excluded if they reported regular use of NSAIDs, reported administration of NSAIDs after fracture, were allergic to study medications, had a buckle fracture, regularly used corticosteroids, and if they had a history of diabetes, renal impairment, and liver disease among others.
In total, 102 patients were enrolled and 95 patients were still enrolled at 6 months of follow-up. Patients included in the study were randomized in a 1:1 ratio to 1 of 2 groups. In group 1, which was referred to as the control group, patients were administered acetaminophen for pain control with dose and frequency of 10-15 mg/kg/dose, with a maximum dose of 1000 mg. For patients in the control group, oxycodone 0.05-0.15 mg/kg/dose was available for breakthrough pain.
In group 2, patients were administered ibuprofen for pain control with dose and frequency 4-10 mg/kg/dose with a maximum of 40 mg/kg/day, with a maximum dose of 3200 mg/day. Similar to the control group, oxycodone was made available for breakthrough pain.
The primary outcome of the study was fracture healing, which was assessed at 2, 6, and 10 weeks. Pain was used as a secondary outcome for the study and investigators also recorded safety and adverse effects through monitoring by an independent safety board.
Of the 95 patients with 6 months of follow-up, 46 patients were included in the control group and 49 were included in the NSAID group. Upon analysis, no patients included in the study had achieved healing. By week 6, 82% of the control group and 92% of the NSAID group had healed fractures (P=.22). At the 10-week follow-up, 98% of the control group fractures had healed and 100% of the NSAID group fractures had healed.
By 6 months, all patients included in the study had achieved healing. When comparing the 2 groups, helloing was achieved at a mean of 40 days in the control group and 31 days in the NSAID group (P=.76). The mean number of days breakthrough oxycodone was used was 2.4 days in the control arm and 1.9 days in the NSAID arm (P=.48).
"We often find that pain management is not adequate with just acetaminophen," Gupta said. "Patients respond better to having two medications at the same time. So, if that second medication can be ibuprofen instead of a narcotic, that's a much safer alternative."
This study, “Effect of NSAID Use on Bone Healing in Pediatric Fractures: A Preliminary, Prospective, Randomized, Blinded Study,” was published in the Journal of Pediatric Orthopaedics.