Association between ondansetron use and symptom persistence in children with concussions: A 5P substudy

Gravel, Jocelyn; Boutis, Kathy; Tang, Ken; Beauchamp, Miriam H.; Freedman, Stephen B.; Dubrovsky, Alexander Sasha; Gagnon, Isabelle; Momoli, Frank; Zemek, Roger

doi:10.1017/cem.2018.384

Cited by 3 publications

(3 citation statements)

References 33 publications

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“…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.…”

Section: Resultsmentioning

confidence: 99%

“…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. Gravel et al (moderate risk of bias) also performed a 2019 prospective observational study of 1805 children who received ondansetron treatment less than 24 hours after experiencing a mild TBI event. This study reported that ondansetron therapy was associated with worsening persistent postconcussion symptoms at 1 month after intervention.…”

Section: Resultsmentioning

confidence: 99%

“…Only 4 of 23 studies were sponsored by the pharmaceutical industry. However, all studies sponsored by pharmaceutical companies reported positive results for the primary outcome, while 68.4% of studies not sponsored by pharmaceutical companies reported benefits associated with the primary outcome . Industry sponsorship has previously been associated with increased reporting of positive results .…”

Section: Discussionmentioning

confidence: 96%

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

et al. 2021

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IMPORTANCE Mild traumatic brain injury (TBI) is experienced by 55.9 million people globally each year. The symptoms of mild TBI are diverse and sometimes long-lasting, requiring frequent use of pharmacological interventions to mitigate them. A thorough understanding of the data supporting pharmacological interventions is important for decision-making among clinicians treating this common injury.OBJECTIVE To systematically review studies of pharmacological interventions and their associations with symptom burden reduction among patients with mild TBI and to use an evidence-based model to identify potential directions for future research that may aid in clinical decision-making.EVIDENCE REVIEW A systematic review was performed in PubMed, Scopus, and Web of Science. Search strings modified for the advanced search interfaces of each search engine were developed in consultation with a librarian and included combinations of search terms, such as brain concussion, post-concussion syndrome, mild traumatic brain injury, and pharmacological treatment. Articles published between January 1, 2000, and July 1, 2020, were analyzed. Studies were included if (1) they were clinical studies with discrete analyses of participants with mild TBI or complicated mild TBI, (2) they were assessments of a pharmacological intervention, (3) they included human participants, and (4) they were published in a peer-reviewed journal in the English language. Studies were excluded if the severity of TBI among participants could not be ascertained (ie, inadequate definition of mild TBI) and the inclusion criteria for the study required intracranial hemorrhage. A total of 23 studies examining 20 pharmacological interventions met the inclusion criteria. Risk of bias was assessed using the Cochrane Risk of Bias for Randomized Trials (for randomized clinical trials) and the Cochrane Risk of Bias in Non-Randomized Studies of Interventions (for all other studies). Data were analyzed from June to September 2020.FINDINGS A total of 1495 articles were identified; of those, 131 articles were excluded as duplicates. Titles and abstracts were screened for inclusion and exclusion criteria among the remaining 1364 articles, and 134 of those articles received a full-text review. After exclusions, 23 studies (11 randomized clinical trials, 7 prospective observational studies, 3 retrospective observational studies, and 2 case studies) examining 20 pharmacological interventions were identified for inclusion in the systematic review. Studies included 22 distinct participant populations comprising 8277 participants with mild TBI and 45 participants without TBI. Among 23 total studies, 8 studies specifically addressed the pediatric population, 9 studies had a low risk of bias, and 16 studies reported symptom burden reduction. Of the 20 pharmacological interventions examined in the studies, methylphenidate, sertraline hydrochloride, ondansetron, amitriptyline, and melatonin were the only medications included in multiple studies.CONCLUSIONS AND RELEVANCE This systematic r...

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