Droperidol vs. prochlorperazine for benign headaches in the emergency department.

OBJECTIVE: To compare the efficacy of droperidol with that of prochlorperazine for the treatment of benign headaches in emergency department (ED) patients. METHODS: Prospective, randomized clinical trial in an urban ED. Patients were given either droperidol, 5 mg intramuscular (IM) or 2.5 mg intravenous (IV), or prochlorperazine, 10 mg IM or 10 mg IV. Measurements included side effects and the patient's pain perception as measured on a 100-mm visual analog scale (VAS) at baseline, 30, and 60 minutes after the medication was given. Data were analyzed using chi-square, two-tailed t-tests, and two-way analysis of variance (ANOVA) when appropriate. RESULTS: During an eight-month period, 168 patients were enrolled. Eighty-two (48.8%) of the patients received droperidol; 86 (51.2%) received prochlorperazine. In the droperidol group, 49 (59.6%) received IM administration and 33 (40.4%) IV. In the prochlorperazine group, 57 (66.3%) received IM administration and 29 (33.7%) IV. Sixty minutes after the medication, the mean decrease in the VAS scores was 81.4% for droperidol and 66.9% for prochlorperazine (p = 0.001). At 30 minutes, 60.9% of the patients receiving droperidol and 44.2% of the patients receiving prochlorperazine had obtained at least a 50% reduction in their VAS scores (p = 0.09). At 60 minutes, 90.2% of the patients receiving droperidol and 68.6% of the patients receiving prochlorperazine had at least a 50% reduction in their VAS scores (p = 0.017). No difference between IM dosing and IV dosing was detected. Side effects, including dystonia, akathisia, and decreased level of consciousness, were seen in 15.2% of the patients receiving droperidol and 9.61% of the patients receiving prochlorperazine. No significant or persisting morbidity was detected. CONCLUSIONS: Droperidol was more effective than prochlorperazine in relieving pain associated with benign headaches.

Effects of hyperbaric oxygenation therapy on cerebral metabolism and intracranial pressure in severely brain injured patients.

OBJECT: Hyperbaric oxygenation (HBO) therapy has been shown to reduce mortality by 50% in a prospective randomized trial of severely brain injured patients conducted at the authors' institution. The purpose of the present study was to determine the effects of HBO on cerebral blood flow (CBF), cerebral metabolism, and intracranial pressure (ICP), and to determine the optimal HBO treatment paradigm. METHODS: Oxygen (100% O2, 1.5 atm absolute) was delivered to 37 patients in a hyperbaric chamber for 60 minutes every 24 hours (maximum of seven treatments/patient). Cerebral blood flow, arteriovenous oxygen difference (AVDO2), cerebral metabolic rate of oxygen (CMRO2), ventricular cerebrospinal fluid (CSF) lactate, and ICP values were obtained 1 hour before and 1 hour and 6 hours after a session in an HBO chamber. Patients were assigned to one of three categories according to whether they had reduced, normal, or raised CBF before HBO. In patients in whom CBF levels were reduced before HBO sessions, both CBF and CMRO2 levels were raised 1 hour and 6 hours after HBO (p < 0.05). In patients in whom CBF levels were normal before HBO sessions, both CBF and CMRO2 levels were increased at 1 hour (p < 0.05), but were decreased by 6 hours after HBO. Cerebral blood flow was reduced 1 hour and 6 hours after HBO (p < 0.05), but CMRO2 was unchanged in patients who had exhibited a raised CBF before an HBO session. In all patients AVDO2 remained constant both before and after HBO. Levels of CSF lactate were consistently decreased 1 hour and 6 hours after HBO, regardless of the patient's CBF category before undergoing HBO (p < 0.05). Intracranial pressure values higher than 15 mm Hg before HBO were decreased 1 hour and 6 hours after HBO (p < 0.05). The effects of each HBO treatment did not last until the next session in the hyperbaric chamber. CONCLUSIONS: The increased CMRO2 and decreased CSF lactate levels after treatment indicate that HBO may improve aerobic metabolism in severely brain injured patients. This is the first study to demonstrate a prolonged effect of HBO treatment on CBF and cerebral metabolism. On the basis of their data the authors assert that shorter, more frequent exposure to HBO may optimize treatment.

Prehospital and resuscitative care of the head-injured patient.

The ultimate neurologic outcome following severe head trauma depends on the extent of primary brain insult sustained at the time of the trauma itself, and the subsequent neurochemical and neurophysiologic pathologic changes occurring as a result of the injury. Although there are currently no specific therapies that have proven to be consistently effective in reversing the devastating consequences of primary brain insult, the reduction or prevention of secondary brain insult is possible. The emergent resuscitation and care of the severely head injured patient can therefore impact the patient's final neurologic outcome. As new data are accumulated, traditional and new therapies for severe head injury have come under scrutiny. While no absolute standards have been advanced, guidelines have been established that can help direct the acute stabilization of severely head injured patients.

An approach to community consultation prior to initiating an emergency research study incorporating a waiver of informed consent.

OBJECTIVES: In November 1996, the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS) enacted rules allowing a narrow exception to the requirement for prospective informed consent when enrolling critically ill patients in clinical research studies of emergency treatments. These rules require that, prior to initiation of the study, the applicable institutional review board (IRB) assess the acceptability of the proposed research study to members of the community in which the research will be conducted. Specifically, the IRB must perform community consultation-a process during which community members learn about the proposed research and communicate their opinions regarding its acceptability to investigators or IRB representatives. The FDA and DHHS rules do not define specific acceptable methods for performing this community consultation. The objective of this study is to demonstrate the feasibility and utility of one proposed method for performing such community consultation. METHODS: Parents of children being seen for minor traumatic injuries in three pediatric EDs were asked to participate in a study regarding informed consent. After consent, an instructor described to the parent a prospective, randomized, placebo-controlled trial of phenytoin for the prophylaxis of posttraumatic seizures in children with severe closed head trauma. All parents were then asked whether they would have consented for their own child's participation, if their child had suffered such head injury. The parents were further asked to explain the reason(s) for their responses. RESULTS: Parents of 227 children (children's mean +/- SD age 8.0 +/- 4.8 years, 57% male) were interviewed. Sixty-six percent of parents (149/227) stated they would give consent for their child's participation. Of the 149 consenting parents, 85% (126/149) cited potential benefit to their child, 72% (107/149) cited potential benefit to other children, and 60% (90/149) cited furthering medical knowledge. Of the 78 nonconsenting parents (34% of total), 54% (42/78) cited fear of adverse effects, 39% (30/78) did not want their child to be a research subject in general, 27% (21/78) believed they needed to discuss participation with family members who were unavailable, and 26% (20/78) stated they were unable to decide unless they were in the actual situation. Parental ethnicity and household income were found to influence the consent decision, while the parent's gender, religion, language, and educational level were not associated with the consent decision. CONCLUSIONS: Community consultation regarding the acceptability of an emergency research protocol can be obtained via interview techniques in the ED. This methodology may allow investigators to obtain data on opinion from a targeted community for IRB consideration during the review of emergency research studies proposing a waiver of informed consent.

Implementing the Food and Drug Administration's final rule for waiver of informed consent in certain emergency research circumstances.

In 1996, the Food and Drug Administration released its Final Rule for Waiver of Informed Consent in Certain Emergency Research Circumstances (the Final Rule). The Department of Health and Human Services (DHHS) also released an update of its regulations related to waiver of informed consent in emergency research. These new regulations allow resuscitation research to proceed with a waiver of informed consent under very narrow and specific clinical research circumstances. Waiving informed consent for research participation has profound ethical and scientific implications. However, in unpredictable life-threatening clinical situations for which current therapy is unproven or unsatisfactory, patients usually are unable to consent on their own behalf to participate in clinical trials of potentially beneficial but experimental interventions. Because of the time-dependent nature of most resuscitation interventions, it is usually not feasible to identify and contact the legally authorized representative who can speak on behalf of the patient within the presumed therapeutic window of the intervention under investigation. For such clinical trials to proceed, a waiver of informed consent is usually necessary. Patients who are critically ill or injured and unable to provide meaningful prospective informed consent because of their current life-threatening condition are vulnerable and require additional protections beyond those for research subjects who can speak on their own behalf. The Final Rule and the DHHS-updated regulations incorporate a number of additional patient safeguards that must occur if a clinical trial is to proceed with waiver of informed consent. Specific means of adequately meeting these requirements are not described in the regulations. Although this was intentional on the part of the federal regulators so that individual protocols and research environments would direct the development of these patient safeguards, the lack of specific guidance has led to confusion on the appropriate implementation of the new regulations. This article reviews some of the key concepts of the Final Rule, with suggestions on their purpose and meaning. It also reviews the studies that have been approved to date to proceed with waiver of informed consent, and offers suggestions for the process of implementing the requirements of the Final Rule for research involving patients who are unable to give prospective informed consent.

The effects of acute and chronic alcohol ingestion on outcome following multiple episodes of mild traumatic brain injury in rats.

OBJECTIVE: Recent studies suggest that in some circumstances, alcohol intoxication at the time of severe head injury may be neuroprotective. The objective of this study was to determine the effect of acute and chronic alcohol ingestion on outcome in rodents sustaining multiple episodes of mild traumatic brain injury while intoxicated. METHOD: For two weeks before experimentation, adult male Sprague-Dawley rats received intoxicating levels of 95% ethanol (3 g/kg) or normal saline (NS) every other day by orogastric instillation. On the day of experimentation, the animals were randomized to receive alcohol or NS. Two hours later, the animals received either mild (1.2 +/- 0.4 ATA) fluid percussion injury (FPI) or no injury. The injured animals received a total of three episodes of FPI (once every four days). Mean reflex recovery time (RRT) was determined (seconds +/- SEM) immediately after each episode. Mean latency time (seconds +/- SEM) for Morris Water Maze (MWM) performance was assessed at post-trauma days 11-19. RESULTS: The chronic alcohol-exposed (CA) and the non-alcohol-exposed (NA) animals intoxicated when injured had prolonged escape, righting, and corneal RRTs after each FPI compared with the nonintoxicated injured animals and the non-injured shams. However, the CA animals had significantly shorter RRTs when compared with the NA rats. All the injured animals had MWM deficits on testing days 1-6 compared with the noninjured controls. On the last two MWM testing days, the injured NA animals had significantly better MWM performance than the injured CA rats. CONCLUSIONS: The injured intoxicated CA animals had a more rapid recovery of reflexes compared with the injured intoxicated NA animals. Despite initial MWM deficits, the injured NA rodents eventually began to learn the MWM. The injured CA rats never learned the maze. Under the conditions of this study, acute alcohol intoxication at the time of multiple episodes of minor head trauma did not provide neuroprotection for NA or CA rodents.

The prevalence and effects of hunger in an emergency department patient population.

OBJECTIVES: Little is known about the prevalence and health effects of hunger among ED patients. The objectives of this study were to determine the prevalence of hunger among patients in a large urban ED and to examine whether it has adverse health effects. METHODS: A survey about hunger, choices between buying food and buying medicine, and adverse health outcomes related to food adequacy over the preceding 12 months was administered to a convenience sample of adult non-critically ill ED patients from afternoon and evening shifts. The study was conducted in the ED of Hennepin County Medical Center in Minneapolis, Minnesota. RESULTS: Of the 302 eligible patients who were asked to participate, 297 (98%) agreed. Eighteen percent reported not having enough to eat at least once in the preceding 12 months: 14% reported that they had "gotten sick" as a result of not being able to afford their medicine, resulting in an ED visit or hospital admission 50% of the time. Predictors of making choices about buying food vs medicine include having a chronic health condition, lack of private health insurance, having a reduction in food stamps, having an annual income less than $10,000, and lack of alcohol use. By patient report, a reduction in food stamps was a predictor of ED visits and hospitalizations as a result of making choices about buying food over medicine. CONCLUSION: The ED patients in this urban setting have high rates of hunger and many must make choices between buying food and medicine, which patients report results in otherwise preventable ED visits and hospitalization. Loss or reduction of food stamps is associated with increased hunger and increased perceived adverse health outcomes as a result of not being able to afford medicine.

Research fundamentals VI: misconduct in biomedical research.

The goal of medical research is the acquisition and application of new knowledge for the benefit of individual patients and society as a whole. Achieving this goal requires excellence in scientific methodology, honesty in data collection and interpretation, and realistic assessment of the implications of the findings. Underlying all steps in the acquisition of new knowledge is the absolute need for application of the highest ethical standards for research. Occasionally, ethical principles of research are breached because of lack of understanding or the carelessness of researchers. However, researchers have the obligation to know and apply basic principles of research ethics in order to avoid, prevent, or recognize deviations from ethical scientific behavior. When intentional violations of the principles of ethical research occur, the impact to the scientific and lay community can be profound. Misconduct can be prevented if the ethical principles of research are understood and consistently applied. This paper describes the sources and detection of misconduct in the production of science in order to provide emergency researchers with the knowledge needed to prevent misconduct from occurring at all.

Research utilization and interdisciplinary collaboration in emergency care.

OBJECTIVES: To examine perceptions of nurse-physician collaboration and research utilization in a large, county medical center with an emergency medicine (EM) residency program, to assess differences among nurses, residents, and attending physicians, and to explore the relationship between collaboration and research utilization. METHODS: A cross-sectional, exploratory, correlational design. Questionnaires measuring four aspects of collaboration-leadership, communication, problem solving, and coordination-and four aspects of research utilization-support, attitude, availability, and use-were distributed to 115 nurses, 18 attending physicians, and 33 EM residents (n = 166). A 59% response rate was achieved. RESULTS: The survey instruments demonstrated acceptable reliability at 0.70 or better Cronbach's alpha except for communication timeliness (alpha = 0.64) and predictive validity. Overall, physicians and nurses rated measures of collaboration and research favorably. However, there were significant differences (p < 0.05) between physicians and nurses on four measures of collaboration (i.e., physician leadership, communication openness within group, communication openness between groups, and problem solving within group) and research utilization (research use), with physicians holding more favorable views than nurses. Three measures of collaboration predicted 47% of the variance in research use for physicians; only one measure of collaboration was important for nurses, explaining 9.3% of the variance in research use. CONCLUSION: Interdisciplinary collaboration showed some significance in promoting research use in the ED, especially for physicians. However, nurse-physician differences in perceptions of collaboration and research use should be examined more fully.