The Use of Ibuprofen and Acetaminophen for Acute Headache in the Post Concussive Youth: A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Number of Headache Days
研究概览
简要总结
Concussions and headache are a significant problem for children and athletes. While headache generally resolves within 7-10 days; a significant proportion of children, 72-93% experience prolonged headache as a symptom of Post Concussion Syndrome (PCS). The prevailing clinical view is that mild head injuries resolve with little chance of complications. However, the reality is quite different. Concussion in children presents with a range of severity and results in both short and long-term physical, cognitive, emotional and behavioural sequelae known as PCS with varying times to resolution. To date there are no specific treatments for headache pain related to concussion. Physical and cognitive rest is the mainstay of initial concussion management.
The number of children presenting to ED's with a history of concussion and headache is increasing. Presently there are no evidence based guidelines available to guide the medical team to effectively and consistently manage their headache. Our present standard of care is based on the CANCHILD concussion guidelines outlining the child's return to school and activity. Yet, our present standard of treatment is compromised and somewhat counterproductive if we are not treating the child's headache pain.
Our pilot study ' An Open Label Randomized Control Pilot Study Examining Treatment of Headache In The Post-Concussive Youth' showed that routine administration of oral analgesia improves the child's headache symptoms and helps with school re-entry one week post injury, compared to a standard care group defined as non routine administration of pain medications.
详细描述
Objective Post Injury concussion and headache are problematic for children after mild traumatic brain injuries. There are no evidence based guidelines for the management of acute post concussive headache. The objectives of this study were to assess the efficacy of routine administration of analgesia on concussion headache and classify headaches using the IHS criteria.
Method A 4 arm open label pilot RCT study was conducted. The treatment arms were: (i) acetaminophen,(ii) ibuprofen, (iii) acetaminophen and ibuprofen and (iv) a standard control group. Eight to eighteen year olds presenting to emergency with headache 24-48 hours after their first concussion were recruited consecutively and sequentially randomized. Demographic data was collected, headache survey administered and standard concussion education given. Headaches were diarized over one week capturing the (i) number of headaches, (ii) headache days,(iii) headache intensity and (iv) return to school.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with a first time concussion
- •english speaking
- •presenting to Emergency with headache 24-48 hours post concussion
- •normal Glascow Coma Scale
- •8-18 years of age
- •Exclusion Criteria
- •postive findings on CT scan
- •patient with cervical injury
- •history of multiple concussions
- •positive neurology
排除标准
- 未提供
研究组 & 干预措施
tx 1: acetaminophen and education
Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
干预措施: Acetaminophen (Drug)
Tx 2: ibuprofen and education
Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency department.
干预措施: Ibuprofen (Drug)
Tx 3: ibuprofen/acetaminophen/education
Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency Department.
干预措施: Acetaminophen (Drug)
Tx 3: ibuprofen/acetaminophen/education
Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.
Patient and family received standard education on concussion management in the Emergency Department.
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Number of Headache Days
时间窗: one week
study participants completed a one week diary at home stating if they had headaches.
次要结局
- Percentage of Study Participants That Returned to School at One Week Post Concussion(one week)
研究者
Dr.Tina Petrelli
McMaster Children's Hospital
McMaster Children's Hospital
