STUDY OBJECTIVE: More than 1 million @entity1 present to US @entity341 ( @entity341 ) annually seeking care for acute @entity2704 . Parenteral antihistamines have long been used in combination with antidopaminergics such as @entity1769 to treat acute @entity2704 in the @entity2613 . High-quality data supporting this practice do not exist. We determine whether administration of @entity3933 50 mg intravenously+ @entity1769 10 mg intravenously results in greater rates of sustained @entity10 relief than placebo+ @entity1769 10 mg intravenously. METHODS: This was a randomized, double-blind, clinical trial comparing 2 active treatments for acute @entity2704 in an @entity2613 . Eligible @entity1 were adults younger than 65 years presenting with an acute moderate or severe @entity10 meeting International Classification of @entity2794 -2 @entity2704 criteria. @entity1 were stratified according to presence or absence of @entity56 . The primary outcome was sustained @entity10 relief, defined as achieving a @entity10 level of mild or none within 2 hours of medication administration and maintaining this level of relief without use of any additional @entity10 medication for 48 hours. Secondary efficacy outcomes included mean improvement on a 0 to 10 verbal scale between baseline and 1 hour, the frequency with which subjects indicated they would want the same medication the next time they present to the @entity2613 with @entity2704 , and the @entity2613 throughput time. Sample size calculation using a 2-sided a of .05, a b of .20, and a 15% difference between study arms determined the need for 374 @entity1 . An interim analysis was conducted when data were available for 200 subjects. RESULTS: Four hundred twenty @entity1 were approached for participation. Two hundred eight eligible @entity1 consented to participate and were randomized. At the planned interim analysis, the data and safety monitoring board recommended that the study be halted for futility. Baseline characteristics were comparable between the groups. Fourteen percent (29/208) of the sample reported @entity56 . Of @entity1 randomized to @entity3933 , 40% (40/100) reported sustained relief at 48 hours, as did 37% (38/103) of @entity1 randomized to placebo (95% confidence interval [CI] for difference of 3%: -10% to 16%). One hour after medication administration, @entity1 randomized to @entity3933 improved by a mean of 5.1 on the 0 to 10 scale versus 4.8 for those randomized to placebo (95% CI for difference of 0.3: -0.6 to 1.1). Eighty-five percent (84/99) of the @entity1 in the @entity3933 arm reported they would want the same medication combination during a subsequent @entity2613 visit, as did 76% (77/102) of those who received placebo (95% CI for difference of 9%: -2% to 20%). Median @entity2613 length of stay was 122 minutes (interquartile range 84 to 180 minutes) in the @entity3933 group and 139 minutes (interquartile range 90 to 235 minutes) in the placebo arm. Rates of adverse effects, including @entity2146 , were comparable between the groups. CONCLUSION: Intravenous @entity3933 , when administered as adjuvant therapy with @entity1769 , does not improve @entity2704 outcomes.

@entity3933 as Adjuvant Therapy for Acute XXXX : An  Emergency Department-Based Randomized Clinical Trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity3933 :: ('MESH:D004155', 'Chemical') :: ['diphenhydramine'] @entity341 :: ('MESH:D004630', 'Disease') :: ['EDs', 'emergency departments'] @entity2704 :: ('MESH:D008881', 'Disease') :: ['migraine'] @entity1769 :: ('MESH:D008787', 'Chemical') :: ['metoclopramide'] @entity2613 :: ('MESH:C536181', 'Disease') :: ['ED'] @entity2794 :: ('MESH:D020773', 'Disease') :: ['Headache Disorders'] @entity56 :: ('MESH:D004342', 'Disease') :: ['allergic symptoms'] @entity2146 :: ('MESH:D011595', 'Disease') :: ['akathisia'] @entity10 :: ('MESH:D006261', 'Disease') :: ['headache']
@entity2704 :: (MESH:D008881,Disease) :: ['Migraine']
