Ondansetron for Pediatric Mild Traumatic Brain Injury
Condition: Traumatic Brain Injury; Brain Concussion
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      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%.
    


Intervention name(s): Ondansetron; PLacebo
Intervention type(s): Drug; Drug
Intervention description(s): The intervention of interest will be the administration of one dose of oral ondansetron in the emergency department. The dosage will be 8 mg.; placebo
Other intervention name(s): Zofran
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild traumatic brain injury; Brain concussion; Post-concussion syndrome; Emergency department; Ondansetron