Benjamin W Friedman1, Eddie Irizarry2, Darnell Cain2, Arianna Caradonna2, Mia T Minen2, Clemencia Solorzano2, Eleftheria Zias2, David Zybert2, Michael McGregor2, Polly E Bijur2, E John Gallagher2. 1. From the Department of Emergency Medicine (B.W.F., E.I., D.C., D.Z., M.M., P.E.B., E.J.G.) and Medical College (A.C.), Albert Einstein College of Medicine, Montefiore, Bronx; Departments of Neurology and Population Health (M.T.M.), NYU Langone Health, New York; and Pharmacy Department (C.S., E.Z.), Montefiore, Bronx, NY. bwfriedmanmd@gmail.com. 2. From the Department of Emergency Medicine (B.W.F., E.I., D.C., D.Z., M.M., P.E.B., E.J.G.) and Medical College (A.C.), Albert Einstein College of Medicine, Montefiore, Bronx; Departments of Neurology and Population Health (M.T.M.), NYU Langone Health, New York; and Pharmacy Department (C.S., E.Z.), Montefiore, Bronx, NY.
Abstract
OBJECTIVE: To determine whether IV metoclopramide 20 mg + diphenhydramine 25 mg (M + D) was more efficacious than IV placebo for acute moderate or severe posttraumatic headache in the emergency room. METHODS: We conducted this randomized, double-blind, placebo-controlled, parallel-group study in 2 urban emergency departments (EDs). Participants who experienced head trauma and presented to our EDs within 10 days with a headache fulfilling criteria for acute posttraumatic headache were included. We randomized participants in a 1:1 ratio to M + D or placebo. Participants, caregivers, and outcome assessors were blinded to assignment. The primary outcome was improvement in pain on a scale of 0 to 10 between baseline and 1 hour after treatment. RESULTS: This study was completed between August 2017 and March 2020. We screened 414 patients for participation and randomized 160: 81 to M + D and 79 to placebo. Baseline characteristics were comparable between the groups. All enrolled participants provided primary outcome data. Patients receiving placebo reported mean improvement of 3.8 (SD 2.6), while those receiving M + D improved by 5.2 (SD 2.3), for a difference favoring metoclopramide of 1.4 (95% confidence interval [CI] 0.7-2.2, p < 0.01). Adverse events were reported by 35 of 81 (43%) patients who received metoclopramide and 22 of 79 (28%) of patients who received placebo (95% CI 1-30 for difference of 15%, p = 0.04). CONCLUSION: M + D was more efficacious than placebo with regard to relief of posttraumatic headache in the ED. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov Identifier: NCT03220958. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with acute moderate or severe posttraumatic headache, IV M + D significantly improved pain compared to placebo.
OBJECTIVE: To determine whether IV metoclopramide 20 mg + diphenhydramine 25 mg (M + D) was more efficacious than IV placebo for acute moderate or severe posttraumatic headache in the emergency room. METHODS: We conducted this randomized, double-blind, placebo-controlled, parallel-group study in 2 urban emergency departments (EDs). Participants who experienced head trauma and presented to our EDs within 10 days with a headache fulfilling criteria for acute posttraumatic headache were included. We randomized participants in a 1:1 ratio to M + D or placebo. Participants, caregivers, and outcome assessors were blinded to assignment. The primary outcome was improvement in pain on a scale of 0 to 10 between baseline and 1 hour after treatment. RESULTS: This study was completed between August 2017 and March 2020. We screened 414 patients for participation and randomized 160: 81 to M + D and 79 to placebo. Baseline characteristics were comparable between the groups. All enrolled participants provided primary outcome data. Patients receiving placebo reported mean improvement of 3.8 (SD 2.6), while those receiving M + D improved by 5.2 (SD 2.3), for a difference favoring metoclopramide of 1.4 (95% confidence interval [CI] 0.7-2.2, p < 0.01). Adverse events were reported by 35 of 81 (43%) patients who received metoclopramide and 22 of 79 (28%) of patients who received placebo (95% CI 1-30 for difference of 15%, p = 0.04). CONCLUSION: M + D was more efficacious than placebo with regard to relief of posttraumatic headache in the ED. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov Identifier: NCT03220958. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with acute moderate or severe posttraumatic headache, IV M + D significantly improved pain compared to placebo.
Authors: Benjamin W Friedman; Laura Mulvey; David Esses; Clemencia Solorzano; Joseph Paternoster; Richard B Lipton; E John Gallagher Journal: Ann Emerg Med Date: 2011-01-12 Impact factor: 5.721
Authors: Serena L Orr; Benjamin W Friedman; Suzanne Christie; Mia T Minen; Cynthia Bamford; Nancy E Kelley; Deborah Tepper Journal: Headache Date: 2016-06 Impact factor: 5.887
Authors: Benjamin W Friedman; Brooke Bender; Michelle Davitt; Clemencia Solorzano; Joseph Paternoster; David Esses; Polly Bijur; E John Gallagher Journal: Ann Emerg Med Date: 2008-09-23 Impact factor: 5.721
Authors: Benjamin W Friedman; Lisa Cabral; Victoria Adewunmi; Clemencia Solorzano; David Esses; Polly E Bijur; E John Gallagher Journal: Ann Emerg Med Date: 2015-08-29 Impact factor: 5.721
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