Ondansetron for pediatric concussion; a pilot randomized controlled trial.
CPS ePoster Library. Gravel J. Jun 25, 2015; 99215; 153
Dr. Jocelyn Gravel
Dr. Jocelyn Gravel
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Background: Most patients suffering from concussion present persistent symptoms at one week post injury. A systematic review showed a paucity of studies for short term outcomes following concussion. Among potential treatments, Ondansetron has shown promising results based on clinical experience and a single retrospective study. Objectives: The primary objective of this pilot study was to assess the clinical efficacy of one dose of oral Ondansetron to decrease post concussion symptoms at one week following concussion in children aged between 8 and 17 years old. Method: This was a randomized, double blinded, controlled trial performed among children aged between 8 and 17 years old who sustained a concussion in the previous 24 hours. Participants visiting the emergency department were randomized to receive one dose of either ondansetron or placebo. The primary outcome of interest was an increase from pre-concussion baseline of at least 3 symptoms from the Post Concussion Symptom Inventory (PCSI) one week following trauma. Secondary outcomes included time to full recovery, mean PCSI score, and outcomes at one month following head trauma. The primary analysis compared the proportion of participants with persistence of symptoms at one week in both groups. This was a pilot study aiming to evaluate the feasibility of the study. Results: A total of 16 children provided informed consent and were randomized to the study medication. They all provided data for the measurement of the primary outcome at one week and one month. The proportion of children with persistent post concussion symptoms was higher in the placebo group but this did not reach statistical significance at one week (difference: 13%; 95%CI: -40% to 69%) and one month (difference: 37%; 95%CI: -15% to 90%). Conclusion: This pilot study demonstrated the feasibility of a randomized controlled trial to evaluate the impact of ondansetron for concussion in children. The administration of one dose of ondansetron in the first 24 hours following concussion showed a trend toward a lower proportion of post-concussion symptoms at one week and one month following intervention. Based on these results, a larger, more powerful study is necessary.
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