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To determine if high-dose epinephrine (HDE) used during out-of-hospital cardiopulmonary arrest refractory to prehospital interventions improves return of spontaneous circulation, 24-hour survival, discharge survival, and neurological outcomes.A multicenter randomized controlled trial was conducted between May 1991 and October 1996 to compare the effectiveness of HDE versus standard-dose epinephrine (SDE) in patients having out-of-hospital cardiopulmonary arrest refractory to prehospital resuscitation efforts. Cardiopulmonary arrest was classified as "medical" or "traumatic." Two hundred thirty patients were enrolled in 7 pediatric emergency departments. Ages ranged from newborn to 22 years. Seventeen patients met exclusion criteria. Patients were assigned to receive HDE (0.1 mg/kg for the initial dose and 0.2 mg/kg for subsequent doses) or SDE (0.01 mg/kg). The main end points evaluated were return of spontaneous circulation, 24-hour survival, discharge survival, and neurological outcome.One hundred twenty-seven patients received HDE (32 trauma patients), and 86 patients received SDE (27 trauma patients). Among medical patients, 24 (25%) of 95 experienced return of spontaneous circulation in the HDE group as compared with 9 (15%) of 59 in the SDE group (P = 0.14, χ2 = 2.17, relative risk = 1.66 [0.83-3.31]). Sixteen (17%) of 95 HDE patients and 5 (8%) of 59 SDE patients survived at least 24 hours (P = 0.14, χ2 = 2.16, relative risk = 1.99 [0.77-5.14]). Nine survivors to discharge received HDE, and 2 received SDE (P = 0.21, Fisher exact test, relative risk = 2.75 [0.61-12.28]). There were no long-term survivors among the trauma patients. Eight of 11 long-term survivors had severe neurological outcomes defined by the Glasgow Outcome Scale (2/2 SDE, 6/9 HDE; P = 0.51, Fisher exact test).HDE does not improve or diminish return of spontaneous circulation, 24-hour survival, long-term survival, or neurological outcome compared with SDE in out-of-hospital cardiopulmonary arrest.