Clinical trial NCT02076321
Conditions: Fractures
Sponsor: University of Missouri-Columbia
Start date: 2014-01-01; Completion date: 2016-11-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, are excellent medications for providing pain control in children with fractures or those who have surgery to correct bony deformity requiring the bone to be cut (osteotomy) and realigned. There is some data to suggest that these types of medications can adversely affect bone healing in adult patients with broken bones or those having spine fusion surgery. There is little data with regard to how these medications effect bone healing in children. With this project, the investigators' goal is to determine if NSAIDs delay or otherwise adversely effect bone healing and to demonstrate that these medications adequately control pain in children with broken bones or those who have had an osteotomy.

Detailed description:
Non-steroidal anti-inflammatory drugs (NSAIDs) are effective in controlling both post-operative pain and pain associated with orthopaedic injuries, particularly in the pediatric population. Additionally, use of NSAIDs for pain control in this setting avoids the use of narcotic pain medications, the adverse effects of which are well known.

Recent research has suggested a possible association between use of NSAIDs and impaired fracture healing in the skeletally mature, or adult, population. Several adult mammal studies have demonstrated inhibition of bony repair with administration of NSAIDs. Yet, other adult animal studies have failed to find the same effect. Clinical data in the adult population is similarly conflicted, with some studies showing an inhibition of bone healing after posterior spinal fusion, while a larger study found no correlation. The data investigating the effects of NSAID use in adults after fracture or osteotomy is even less clear with some studies demonstrating higher rates of non-union with NSAID administration and others finding no significant effect on bone healing.

The research investigating these outcomes in the skeletally immature population is limited; one study compared administration of ketorolac versus normal saline for 7, 14 and 21 days in a juvenile rat model with a stabilized tibia fracture. They found no significant difference in strength, stiffness or histological characteristics of fracture callus between the two groups. Clinical retrospective studies of the pediatric population with regard to use of NSAIDs after posterior spinal fusion have failed to reproduce findings of inhibitory effects on bone healing. Similarly, two retrospective studies found no cases of delayed union or non-union in pediatric patients who received perioperative ketorolac around the time of operative fixation of fractures, or osteotomy. Given these results, the way in which and the degree to which NSAIDs perturb the inflammatory mileu during the acute phase of healing is potentially distinct from the effects on bone healing in the skeletally mature.

There have been no clinical prospective, randomized studies to evaluate the effect, if any, that NSAIDs have on bone healing in the skeletally immature patient population. The investigators hypothesize that NSAID administration in the acute phase of bone healing, whether it be a fracture or osteotomy, will not result in delayed union or non-union as compared to patients who take acetaminophen for pain control during this same time period.

Arms: arm 1: control group arm 2: Study group
Interventions: intervention 1: Acetaminophen intervention 2: Ibuprofen
Intervention descriptions: intervention 1: acetaminophen for pain control with dose and frequency of 10-15mg/kg/dose, Maximum dose 1000mg. Maximum amount per day: 75mg/kg (not to exceed 4g/day). intervention 2: ibuprofen for pain control with dose and frequency 4-10mg/kg/dose. Maximum of 40mg/kg/day, not to exceed 3,200mg/day. Maximum one-time dose of 800mg.

Protocol documents: