Ondansetron for pediatric concussion; a pilot study for a randomized controlled trial

Abstract

Objectives: Assess the feasibility of a study evaluating one dose of oral ondansetron to decrease post-concussion symptoms at one week and one month following concussion in children aged 8 to 17 years old. Method: This was a pilot study for a randomized, triple-blind controlled trial of one dose of either ondansetron or placebo performed in a tertiary care pediatric emergency department. Participants were children aged 8 to 17 years who sustained a concussion in the previous 24 hours and visited a single emergency department. The outcome of interest was an increase from pre-concussion baseline of at least 3 symptoms from the Post-Concussion Symptom Inventory, measured at one week and at one month following concussion. The primary outcome was to determine the proportion of children who completed the assessment at one week following the intervention. Secondary outcome was the proportion of children who completed the assessment at one month following the intervention. All children, care givers, and those assessing the outcomes were blinded to the group assignment. Results: Of the 218 children presenting with a concussion during the study period, we screened 108 and found 36/108 (33%) eligible to participate and 16/108 (14.8%) agreed to participate. All enrolled patients were compliant with the intervention and follow-up. Conclusion: In our study population, approximately one-third of the screened concussion patients were eligible to participate and approximately one half of those eligible agreed to participate. Our study found that most enrolled patients preferred electronic follow-up; the noncompliance rate was minimal.

Association of Pharmacological Interventions With Symptom Burden Reduction in Patients With Mild Traumatic Brain Injury

“…A total of 45 healthy participants without mild TBI were included in the control groups of 2 studies . Eight studies examined pediatric participants, totaling 2139 participants with mild TBI who were 18 years or younger . Data extraction summaries are reported in Table 1, and Table 2; meta-statistics are summarized in Figure 1 and Figure 2 and eFigure 2 and eFigure 3 in the Supplement.…”

“…In 2017, Gravel et al (low risk of bias) conducted an RCT among 16 children, with time from injury to intervention of less than 24 hours, to assess the feasibility of ondansetron therapy. This study did not report any substantial benefits associated with ondansetron treatment with regard to postconcussion symptoms, length of hospital stay, or measures assessing the timing of the children’s return to school or normal activity compared with placebo.…”