Cheryl Vance

A decision rule for identifying children at low risk for brain injuries after blunt head trauma

STUDY OBJECTIVE Computed tomography (CT) is frequently used in evaluating children with blunt head trauma. Routine use of CT, however, has disadvantages. Therefore, we sought to derive a decision rule for identifying children at low risk for traumatic brain injuries. METHODS We enrolled children with blunt head trauma at a pediatric trauma center in an observational cohort study between July 1998 and September 2001. We evaluated clinical predictors of traumatic brain injury on CT scan and traumatic brain injury requiring acute intervention, defined by a neurosurgical procedure, antiepileptic medications for more than 1 week, persistent neurologic deficits, or hospitalization for at least 2 nights. We performed recursive partitioning to create clinical decision rules. RESULTS Two thousand forty-three children were enrolled, 1,271 (62%) underwent CT, 98 (7.7%; 95% confidence interval [CI] 6.3% to 9.3%) had traumatic brain injuries on CT scan, and 105 (5.1%; 95% CI 4.2% to 6.2%) had traumatic brain injuries requiring acute intervention. Abnormal mental status, clinical signs of skull fracture, history of vomiting, scalp hematoma (in children < or =2 years of age), or headache identified 97/98 (99%; 95% CI 94% to 100%) of those with traumatic brain injuries on CT scan and 105/105 (100%; 95% CI 97% to 100%) of those with traumatic brain injuries requiring acute intervention. Of the 304 (24%) children undergoing CT who had none of these predictors, only 1 (0.3%; 95% CI 0% to 1.8%) had traumatic brain injury on CT, and that patient was discharged from the ED without complications. CONCLUSION Important factors for identifying children at low risk for traumatic brain injuries after blunt head trauma included the absence of: abnormal mental status, clinical signs of skull fracture, a history of vomiting, scalp hematoma (in children < or =2 years of age), and headache.

Lorazepam vs Diazepam for Pediatric Status Epilepticus: A Randomized Clinical Trial

IMPORTANCE Benzodiazepines are considered first-line therapy for pediatric status epilepticus. Some studies suggest that lorazepam may be more effective or safer than diazepam, but lorazepam is not Food and Drug Administration approved for this indication. OBJECTIVE To test the hypothesis that lorazepam has better efficacy and safety than diazepam for treating pediatric status epilepticus. DESIGN, SETTING, AND PARTICIPANTS This double-blind, randomized clinical trial was conducted from March 1, 2008, to March 14, 2012. Patients aged 3 months to younger than 18 years with convulsive status epilepticus presenting to 1 of 11 US academic pediatric emergency departments were eligible. There were 273 patients; 140 randomized to diazepam and 133 to lorazepam. INTERVENTIONS Patients received either 0.2 mg/kg of diazepam or 0.1 mg/kg of lorazepam intravenously, with half this dose repeated at 5 minutes if necessary. If status epilepticus continued at 12 minutes, fosphenytoin was administered. MAIN OUTCOMES AND MEASURES The primary efficacy outcome was cessation of status epilepticus by 10 minutes without recurrence within 30 minutes. The primary safety outcome was the performance of assisted ventilation. Secondary outcomes included rates of seizure recurrence and sedation and times to cessation of status epilepticus and return to baseline mental status. Outcomes were measured 4 hours after study medication administration. RESULTS Cessation of status epilepticus for 10 minutes without recurrence within 30 minutes occurred in 101 of 140 (72.1%) in the diazepam group and 97 of 133 (72.9%) in the lorazepam group, with an absolute efficacy difference of 0.8% (95% CI, -11.4% to 9.8%). Twenty-six patients in each group required assisted ventilation (16.0% given diazepam and 17.6% given lorazepam; absolute risk difference, 1.6%; 95% CI, -9.9% to 6.8%). There were no statistically significant differences in secondary outcomes except that lorazepam patients were more likely to be sedated (66.9% vs 50%, respectively; absolute risk difference, 16.9%; 95% CI, 6.1% to 27.7%). CONCLUSIONS AND RELEVANCE Among pediatric patients with convulsive status epilepticus, treatment with lorazepam did not result in improved efficacy or safety compared with diazepam. These findings do not support the preferential use of lorazepam for this condition. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00621478.

Comparison of skin stapling devices and standard sutures for pediatric scalp lacerations: A randomized study of cost and time benefits

OBJECTIVE To compare the total costs and the physician time requirements for suture and staple repair of pediatric scalp lacerations. STUDY DESIGN Eighty-eight children, 13 months to 16 years of age, coming to a childrens hospital emergency department with simple scalp lacerations were prospectively randomly selected to receive staple or suture repair. Wound lengths, times required for initial wound care and closure, and equipment use were recorded. Patients returned in 1 week for suture or staple removal and wound reevaluation. The two methods were compared in terms of both time expended and costs of equipment and physician compensation. RESULTS Forty-five children underwent staple repair and 43 underwent suture repair. There were no differences in age, sex, wound length, number of sutures or staples per centimeter, or physician experience. Stapling resulted in shorter wound closure times (65 vs 397 seconds; p < 0.0001) and shorter overall times for wound care and closure (395 vs 752 seconds; p < 0.0001). Staple repair was less expensive in terms of equipment (

Pharmacokinetics of Intravenous Lorazepam in Pediatric Patients with and without Status Epilepticus

12.55 vs

Failure of technetium-99m hexamethylpropylene amine oxime leukocyte scintigraphy in the evaluation of children with suspected appendicitis

17.59; p < 0.0001) and total cost based on equipment and physician time (

Perceived Challenges to Obtaining Informed Consent for a Time-sensitive Emergency Department Study of Pediatric Status Epilepticus: Results of Two Focus Groups

23.55 vs

Variation in Specialists’ Reported Hospitalization Practices of Children Sustaining Blunt Head Trauma

38.51; p < 0.0001). The follow-up rate was 91%, with no cosmetic or infectious complications in either group. CONCLUSIONS Stapling is faster and less expensive than suturing in the repair of uncomplicated pediatric scalp lacerations, with no additional complications. Physicians who treat children with scalp lacerations should consider the use of stapling devices.

Variation of community consultation and public disclosure for a pediatric multi-centered "Exception from Informed Consent" trial

OBJECTIVE To evaluate the single dose pharmacokinetics of an intravenous dose of lorazepam in pediatric patients treated for status epilepticus (SE) or with a history of SE. STUDY DESIGN Ten hospitals in the Pediatric Emergency Care Applied Research Network enlisted patients 3 months to 17 years with convulsive SE (status cohort) or for a traditional pharmacokinetics study (elective cohort). Sparse sampling was used for the status cohort, and intensive sampling was used for the elective cohort. Non-compartmental analyses were performed on the elective cohort, and served to nest compartmental population pharmacokinetics analysis for both cohorts. RESULTS A total of 48 patients in the status cohort and 15 patients in the elective cohort were enrolled. Median age was 7 years, 2 months. The population pharmacokinetics parameters were: clearance, 1.2 mL/min/kg; half-life, 16.8 hours; and volume of distribution, 1.5 L/kg. On the basis of the pharmacokinetics model, a 0.1 mg/kg dose is expected to achieve concentrations of approximately 100 ng/mL and maintain concentrations >30 to 50 ng/mL for 6 to 12 hours. A second dose of 0.05 mg/kg would achieve desired therapeutic serum levels for approximately 12 hours without excessive sedation. Age-dependent dosing is not necessary beyond using a maximum initial dose of 4 mg. CONCLUSIONS Lorazepam pharmacokinetics in convulsive SE is similar to earlier pharmacokinetics measured in pediatric patients with cancer, except for longer half-life, and similar to adult pharmacokinetics parameters except for increased clearance.

Randomised controlled trial of Lactobacillus rhamnosus (LGG) versus placebo in children presenting to the emergency department with acute gastroenteritis: The PECARN probiotic study protocol

To determine the accuracy and reliability of a labeled leukocyte imaging technique in the early diagnosis of pediatric appendicitis, we prospectively studied patients presenting to the pediatric emergency department with abdominal pain suggestive of appendicitis. Patients scheduled for urgent laparotomy were excluded, as were postmenarchal females. Blinded interpretations by two independent radiologists were compared with surgical findings, if managed operatively, or with discharge diagnoses and three week follow-up, if managed medically. Twenty-three children underwent technetium-99m hexamethylpropylene amine oxime (HMPAO) leukocyte scintigraphy. Seven had pathologically proven appendicitis, with false negative interpretations made in three and five cases by the two radiologists. Sixteen patients had prompt resolution of symptoms; however, scintigraphic abnormalities were identified in 10 and seven cases by the two radiologists. Resulting sensitivity, depending on the individual reader, ranged from 29 to 57%, with specificity 38 to 56%, positive predictive value 22 to 29%, negative predictive value 64 to 67%, and accuracy 43 to 48%. Interrater reliability for agreement on the scintigraphic diagnosis of appendicitis was poor (kappa = 0.38). Technetium-99m HMPAO leukocyte scintigraphy was neither accurate nor reliable as a diagnostic tool in a subgroup of pediatric patients with an initial clinical presentation equivocal for appendicitis. This finding contradicts previously published experience using similar scintigraphic techniques.

Diagnostic performance of a biomarker panel as a negative predictor for acute appendicitis in adult ED patients with abdominal pain

OBJECTIVES The objective was to describe the perspective of research personnel on issues of informed consent in a time-sensitive clinical study under emergency circumstances. METHODS The authors convened concurrent focus groups of research staff and investigators involved in a pharmacokinetic study of lorazepam for status epilepticus (SE). Moderators led discussion with open-ended questions on selected issues of parental consent, communication and understanding, patient assent, and comparison to other types of studies. Focus group transcripts were analyzed to identify themes and subthemes from the discussions. RESULTS Most themes and subthemes were identified in both research staff and investigator focus groups. Focus group discussion points were categorized into three main themes: barriers to and enablers of informed consent, barriers to and enablers of actual enrollment, and overall ethical concerns about the research. Many of the issues identified were unique to emergency research. CONCLUSIONS From the perspectives of research staff and investigators enrolling patients in a time-sensitive emergency department study, the authors identified several areas of concern that should be addressed when planning future emergency studies.