Petrelli Tina, Farrokhyar Forough, McGrath Patricia, Sulowski Chris, Sobhi Gita, DeMatteo Carol, Giglia Lucia, Singh Sheila K
Department of Surgery, McMaster University, Hamilton, Ontario.
McMaster Children's Hospital, Hamilton, Ontario.
Paediatr Child Health. 2017 Mar;22(1):2-6. doi: 10.1093/pch/pxw011. Epub 2017 Mar 27.
Acute postconcussive headaches are problematic for children after mild traumatic brain injury. There are no evidence-based guidelines for their management. This pilot study aims to assess the feasibility and efficacy of routine analgesia administration.
A four-arm open-label randomized controlled trial pilot/feasibility study was conducted: (i) acetaminophen, (ii) ibuprofen, (iii) alternating acetaminophen and ibuprofen and (iv) a control group. Children and youth 8 to 18 years of age presenting to emergency department with headache within 48 hours of their first concussion were recruited consecutively and sequentially randomized. Children with abnormal neuroimaging, history of previous concussions and bleeding disorder were excluded. A headache survey was administered at recruitment. All participants were provided with standard concussion management education and were also instructed on how to use the headache diary for the 1-week study follow-up period. The diary captures (i) headache days, (ii) number of headaches, (iii) headache intensity and (iv) return-to-school information. Feasibility was assessed based on study recruitment and compliance.
There were no feasibility concerns with the recruitment and no major compliance issues. Patients on acetaminophen, ibuprofen or both had significantly less headache days, episodes of headache and lower headache intensity than did the standard care group. Patients on both ibuprofen and acetaminophen (79.0%) and on ibuprofen alone (61.0%) were more likely to be back at school 1 week postinjury as compared with the acetaminophen group (33.3%) and the standard care group (21.1%).
Results showed routine analgesia administration was feasible and effective for postconcussive headache management. A larger full-scale randomized controlled trial is required to further assess the efficacy with longer follow-up, a wider variety of patients and more concussion related outcomes.
轻度创伤性脑损伤后,急性脑震荡后头痛对儿童来说是个问题。目前尚无基于证据的管理指南。这项初步研究旨在评估常规镇痛治疗的可行性和有效性。
进行了一项四臂开放标签随机对照试验试点/可行性研究:(i)对乙酰氨基酚组,(ii)布洛芬组,(iii)对乙酰氨基酚与布洛芬交替组,以及(iv)对照组。连续招募并按顺序随机分配8至18岁在首次脑震荡后48小时内因头痛到急诊科就诊的儿童和青少年。排除神经影像学异常、既往有脑震荡病史和出血性疾病的儿童。招募时进行头痛调查。所有参与者都接受了标准的脑震荡管理教育,并被指导如何在为期1周的研究随访期内使用头痛日记。该日记记录(i)头痛天数,(ii)头痛次数,(iii)头痛强度,以及(iv)返校信息。基于研究招募和依从性评估可行性。
在招募方面没有可行性问题,也没有重大的依从性问题。与标准护理组相比,服用对乙酰氨基酚、布洛芬或两者的患者头痛天数、头痛发作次数显著减少,头痛强度更低。与对乙酰氨基酚组(33.3%)和标准护理组(21.1%)相比,服用布洛芬和对乙酰氨基酚的患者(79.0%)和仅服用布洛芬的患者(61.0%)在受伤后1周更有可能返校。
结果表明常规镇痛治疗对脑震荡后头痛的管理是可行且有效的。需要进行更大规模的全随机对照试验,以通过更长时间的随访、更广泛的患者群体和更多与脑震荡相关的结果来进一步评估疗效。