Impact of IV metoclopramide + diphenhydramine on post-concussion symptoms. A secondary analysis of data from an ED-based randomized study
Abstract
Background: In a randomized, placebo-controlled study, intravenous metoclopramide 20 mg + diphenhydramine 25 mg (M+D) improved post-concussion symptoms 1 h later among patients seeking care in an emergency department (ED) following head trauma. We performed a secondary hypothesis-generating analysis of those data to determine whether M+D is effective against cognitive and affective symptoms in addition to somatic symptoms, and whether post-treatment symptomatology is associated with 1-week and 1-month outcomes.
Methods: We enrolled patients in two urban EDs in the Bronx, NY. Enrollment commenced in August 2017 and concluded in March 2020. Patients were included in the initial randomized controlled trial if they experienced head trauma and reported a new onset headache of at least moderate or severe intensity. We assessed post-concussion symptoms at 1 h, 1 week, and 1 month after treatment using the Post-Concussion Symptom Scale (PCSS), a 22-item instrument on which each symptom is graded as zero (none) through 6 (severe). We determined the impact of treatment, time, and their interaction on PCSS score. We repeated this analysis among the somatic, cognitive, and affective domains of the PCSS scale. Finally, we determined if post-treatment PCSS scores in the ED were associated with any severe symptom 1 week and 1 month later.
Results: Eighty-one participants received M+D; of those, 30 (37.0%) were female. Their mean age was 43.3 (standard deviation 16.1) years. All 81 provided…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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