Clinical Trial: Ondansetron for Pediatric Mild Traumatic Brain Injury

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Ondansetron for Pediatric Mild Traumatic Brain Injury; a Pilot Randomized Controlled Trial.

Brief 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 followin

Detailed Summary:
Sponsor: St. Justine's Hospital

Current Primary Outcome: Persistence of post concussive symptoms [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mean number of PCSI symptoms [ Time Frame: one week and month following intervention ]
  • Mean number of school days missed [ Time Frame: one month following intervention ]
  • Number of days of sport activity restriction [ Time Frame: 1 month following intervention ]
  • Time before full recovery [ Time Frame: One month following intervention ]
    According to the parents
  • Healthcare utilization [ Time Frame: One month following intervention ]
    Proportion of participants who consulted a health resource.
  • Side effects [ Time Frame: one week and month following intervention ]
    Side effects will include, in addition to symptoms related to mTBI,proportion of participants who complained of diarrhea or constipation (binary answer).


Original Secondary Outcome:

  • Mean number of PCSI symptoms [ Time Frame: one week and month following intervention ]
  • Mean number of school days missed [ Time Frame: one month following intervention ]
  • Number of days of sport activity restriction [ Time Frame: 1 month following intervention ]
  • Time before full recovery [ Time Frame: One month following intervention ]
    According to the parents
  • Healthcare utilization [ Time Frame: One month following intervention ]
    Proportion of participants who consulted a health ressource.
  • Side effects [ Time Frame: one week and month following intervention ]
    Side effects will include, in addition to symptoms related to mTBI,proportion of particpants who complained of diarrhea or constipation (binary answer).


Information By: St. Justine's Hospital

Dates:
Date Received: March 18, 2013
Date Started: March 2013
Date Completion:
Last Updated: September 28, 2015
Last Verified: February 2014