@entity842 for inhalation in the acute treatment of sickle cell XXXX crisis: a randomized controlled trial.

@entity1 @entity1568 @entity3961 @entity19 @entity3542 @entity3458 @entity1507 @entity5837 @entity842 @entity158
CONTEXT: Inhaled @entity842 has shown evidence of efficacy in @entity19 models of @entity3458 ( @entity3458 ), case series of @entity1 with @entity5837 , and 2 small placebo-controlled trials for treatment of vaso-occlusive @entity158 crisis (VOC). OBJECTIVE: To determine whether inhaled @entity842 gas reduces the duration of @entity158 in @entity1 with @entity3458 who present to the emergency department or hospital for care. DESIGN, SETTING, AND @entity1 : Prospective, multicenter, double-blind, randomized, placebo-controlled clinical trial for up to 72 hours of inhaled @entity842 gas vs inhaled @entity1568 placebo in 150 @entity1 presenting with VOC of @entity3458 at 11 centers between October 5, 2004, and December 22, 2008. Intervention Inhaled @entity842 gas vs inhaled @entity1568 placebo. MAIN OUTCOME MEASURES: The primary end point was the time to resolution of @entity158 , defined by (1) freedom from parenteral opioid use for 5 hours; (2) @entity158 relief as assessed by visual analog @entity158 scale scores of 6 cm or lower (on 0-10 scale); (3) ability to walk; and (4) @entity1 's and family's decision, with physician consensus, that the remaining @entity158 could be managed at home. RESULTS: There was no significant change in the primary end point between the @entity842 and placebo groups, with a median time to resolution of crisis of 73.0 hours (95% confidence interval [CI], 46.0-91.0) and 65.5 hours (95% CI, 48.1-84.0), respectively (P = .87). There were no significant differences in secondary outcome measures, including length of hospitalization, visual analog @entity158 scale scores, cumulative opioid usage, and rate of @entity5837 . Inhaled @entity842 was well tolerated, with no increase in serious adverse events. Increases in venous @entity3961 concentration confirmed adherence and randomization but did not exceed 5% in any study @entity1 . Significant increases in plasma @entity1507 occurred in the treatment group, but there were no observed increases in plasma or whole blood @entity3542 . CONCLUSION: Among @entity1 with @entity3458 hospitalized with VOC, the use of inhaled @entity842 compared with placebo did not improve time to crisis resolution. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00094887.
