Ondansetron for Pediatric Mild Traumatic Brain Injury; a Pilot Randomized Controlled Trial.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Persistence of post concussive symptoms
研究概览
简要总结
Background: Most patients suffering from mild Traumatic Brain Injury (mTBI) present persistent symptoms at one week post injury. A systematic review showed a paucity of studies for short term outcomes following mTBI. Among potential treatments for mTBI, ondansetron has shown promising results based on clinical experience and a single retrospective study. Objectives: The primary objective of this pilot study is to determine the feasibility of a randomized controlled trial evaluating the effect of ondansetron to decrease post concussion symptoms at one week following mTBI in children. More specifically, this pilot study will evaluate the proportion of participants who complete assessment at one week following intervention. Method: This will be a randomized, double blinded, controlled trial performed among children aged between 8 and 17 years old who sustained a mTBI in the previous 24 hours. Participants visiting the emergency department will be randomized to receive one dose of either ondansetron or placebo. The primary outcome of interest is defined as an increase from pre-concussion baseline of at least 3 symptoms from the Post Concussion Symptom Inventory (PCSI) one week following trauma. Secondary outcomes will include time to full recovery, mean PCSI score, and outcomes at one month following head trauma. The primary analysis will compare the proportion of participants with persistence of symptoms at one week in both groups. The full study sample size was calculated to have 90% power to detect a decrease in the proportion of persistence of symptoms from 50% to 30% with an alpha value of 0.05. Approximately 126 patients will therefore be recruited in each arm. The investigators plan to recruit 30 participants (10% of the final population) for the pilot study. Expected results: This pilot study should confirm the feasibility of the randomized controlled trial by showing that 90% of the recruited participants provide data on the primary outcome at one week following intervention. On the long term, the investigator expect that ondansetron will decrease the proportion of patients sustaining persistent symptoms of concussion from 50% to lower than 30%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 8 and 17 years old. This will be limited to this small spectrum of age to insure better homogeneity in the evaluation of the participants and streamlining of outcome measures. Also, this is the age group for which our measurement tool has been validated.
- •Occurrence of a mTBI as defined by the presence of a head trauma, a Glasgow coma scale of 13 to 15 and at least one of the three following criteria4 :
- •Any period of loss of consciousness.
- •Any loss of memory for events immediately before or after the accident.
- •Any alteration in mental state at the time of the accident (eg, feeling dazed, disoriented).
- •And the absence of the following criteria:
- •Post-traumatic amnesia greater than 24 hours.
- •Glasgow Coma Scale < 13, 30 minutes post accident.
- •The trauma occurred in the preceding 24 hours.
排除标准
- •Inability to obtain a proper written informed consent (language barrier, absence of a parental authority, developmental delay, intoxication, patient too confuse to consent according to the treating physician).
- •Known allergic reaction or intolerance to ondansetron.
- •Known rhythm or cardiac problem, or history of sudden death in the proximal family
- •Patients who are taking a medication which could increase the QT interval.
- •Patients who received ondansetron in the previous 24 hours
- •Any abnormality on radiological studies, including any bleeding in the brain or skull fracture.
- •Multi-system injuries with treatment requiring admission to hospital or procedural sedation in the ED.
研究组 & 干预措施
Ondansetron
The intervention of interest will be the administration of one dose of oral ondansetron in the emergency department. The dosage will be 8 mg.
干预措施: Ondansetron (Drug)
Placebo
The control group will receive a similar looking/ tasting pill of placebo.
干预措施: PLacebo (Drug)
结局指标
主要结局
Persistence of post concussive symptoms
时间窗: 1 week post intervention
Persistence of post concussive symptoms will be defined by an increase from pre-concussion baseline of at least 3 symptoms of the Post Concussion Symptom Inventory (PCSI). The PCSI is a self-report tool evaluating the presence of 25 symptoms (on a 3-point likert scale) for children 8-12 and 26 symptoms on a (7-point likert scale) for children 13-17 years. An increase of two points or more from pre-injury in any symptom is considered clinically significant.
次要结局
- Side effects(one week and month following intervention)
- Time before full recovery(One month following intervention)
- Healthcare utilization(One month following intervention)
- Number of days of sport activity restriction(1 month following intervention)
- Mean number of PCSI symptoms(one week and month following intervention)
- Mean number of school days missed(one month following intervention)
研究者
Jocelyn Gravel
MD, MSc
St. Justine's Hospital