Nuelle Julia A V, Coe Kelsie M, Oliver Harvey A, Cook James L, Hoernschemeyer Daniel G, Gupta Sumit K
Department of Orthopaedic Surgery, University of Missouri Health System, Columbia, MO.
J Pediatr Orthop. 2020 Sep;40(8):e683-e689. doi: 10.1097/BPO.0000000000001603.
This study aimed to investigate if nonsteroidal anti-inflammatory drugs (NSAIDs) used in the acute phase of bone healing in children with fractures result in delayed union or nonunion as compared with patients who do not take NSAIDs for pain control during this same time period.
In this prospective, randomized, parallel, single-blinded study, skeletally immature patients with long bone fractures were randomized to 1 of 2 groups for their postfracture pain management. The NSAID group was prescribed weight-based ibuprofen, whereas the control group was not allowed any NSAID medication and instead prescribed weight-based acetaminophen. Both groups were allowed to use oxycodone for breakthrough pain. The primary outcome was fracture healing assessed at 2, 6, and 10 weeks.
One-hundred-two patients were enrolled between February 6, 2014 and September 23, 2016. Ninety-five patients (with 97 fractures) completed a 6-month follow-up (46 patients with 47 fractures in the control group and 49 patients 50 fractures in the NSAID group). None achieved healing at 1 to 2 weeks. By 6 weeks, 37 of 45 patients (82%) of control group and 46 out of 50 patients (92%) of ibuprofen group had healed fractures (P=0.22). At 10 to 12 week follow-up, 46 (98%) of the control group fractures were healed and 50 (100%) of the ibuprofen group fractures were healed. All were healed by 6 months. Healing was documented at a mean of 40 days in the control group and 31 days in the ibuprofen group (P=0.76). The mean number of days breakthrough oxycodone was used was 2.4 days in the control group and 1.9 days in the NSAID group (P=0.48).
Ibuprofen is an effective medication for fracture pain in children and its use does not impair clinical or radiographic long bone fracture healing in skeletally immature patients.
Level I-therapeutic.
本研究旨在调查在骨折儿童的骨愈合急性期使用非甾体抗炎药（NSAIDs）与在同一时期不服用NSAIDs进行疼痛控制的患者相比，是否会导致骨折延迟愈合或不愈合。
在这项前瞻性、随机、平行、单盲研究中，骨骼未成熟的长骨骨折患者被随机分为两组之一进行骨折后疼痛管理。NSAIDs组按体重给予布洛芬，而对照组不允许使用任何NSAIDs药物，而是按体重给予对乙酰氨基酚。两组均允许使用羟考酮治疗爆发性疼痛。主要结局是在2周、6周和10周时评估骨折愈合情况。
2014年2月6日至2016年9月23日期间共纳入102例患者。95例患者（97处骨折）完成了6个月的随访（对照组46例患者47处骨折，NSAIDs组49例患者50处骨折）。1至2周时均未实现骨折愈合。到6周时，对照组45例患者中的37例（82%）和布洛芬组50例患者中的46例（92%）骨折已愈合（P=0.22）。在10至12周随访时，对照组46处（98%）骨折已愈合，布洛芬组50处（100%）骨折已愈合。所有骨折在6个月时均已愈合。对照组骨折愈合记录的平均天数为40天，布洛芬组为31天（P=0.76）。对照组使用羟考酮治疗爆发性疼痛的平均天数为2.4天，NSAIDs组为1.9天（P=0.48）。
布洛芬是治疗儿童骨折疼痛的有效药物，其使用不会损害骨骼未成熟患者临床或影像学上长骨骨折的愈合。
I级——治疗性。
