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


METHODS
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.


CONCLUSIONS
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.
*Département de Pédiatrie,CHU Sainte-Justine,Université de Montréal,Montréal,QC.
Jocelyn
J
Gravel
*Département de Pédiatrie,CHU Sainte-Justine,Université de Montréal,Montréal,QC.
Benoit
B
Carrière
*Département de Pédiatrie,CHU Sainte-Justine,Université de Montréal,Montréal,QC.
Antonio
A
D'Angelo
†Département de Chirurgie,CHU Sainte-Justine,Université de Montréal,Montréal,QC.
Louis
L
Crevier
‡Département de Psychologie,Université de Montréal,Montréal,QC.
Miriam H
http://orcid.org/0000-0002-8637-6361
MH
Beauchamp
§Centre de recherche du CHU Sainte-Justine,Université de Montréal,Montréal,QC.
Benoît
B
Mâsse
D000284:Administration, Oral; D000293:Adolescent; D001924:Brain Concussion / Q000188:drug therapy*; D002648:Child; D004311:Double-Blind Method; D004636:Emergency Service, Hospital; D005260:Female; D005500:Follow-Up Studies; D015600:Glasgow Coma Scale; D006801:Humans; D015601:Injury Severity Score; D016014:Linear Models; D008297:Male; D017294:Ondansetron / Q000627:therapeutic use*; D010865:Pilot Projects; D038223:Post-Concussion Syndrome / Q000175:diagnosis / Q000188:drug therapy; D012016:Reference Values; D012702:Serotonin Antagonists / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D012702:Serotonin Antagonists; D017294:Ondansetron
children; concussion; mTBI; ondansetron