A patient with seizures and a positive drug screen: three wrongs don't make a right.
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Adolescent↗
Biomedical subjects
Eran Kozer
Publications and source records attributed to Eran Kozer.
The safety of oral hypoglycemic agents in the first trimester of pregnancy: a meta-analysis.
OBJECTIVE: To examine the relationship between first-trimester exposure to oral hypoglycemic agents (OHAs), congenital anomalies and neonatal mortality, accounting for the potential confounding effect of maternal glycemic control. METHOD: A meta-analysis was conducted by searching the literature for studies reporting on women with type II diabetes mellitus, first-trimester exposure to OHAs and either major malformations and/or neonatal mortality. Glycemic control monitoring was noted. Studies were reviewed by two reviewers and disagreement was resolved by consensus. Odds ratios and risk differences were calculated to determine the risk of major malformations and neonatal mortality between those exposed and those not exposed to OHAs. RESULTS: Ten studies met the inclusion criteria. There was no significant difference in the rates of major malformations between those exposed and those not exposed to OHAs; the odds ratio was 1.05 (95% CI 0.65 to 1.70) and the risk difference was 0.00 (95% CI -0.03 to 0.03). For studies reporting glycemic control, the odds ratio for major malformations between those exposed and those not exposed to OHAs was 1.06 (95% CI 0.62 to 1.81). For neonatal death, the odds ratio was 1.16 (95% CI 0.67 to 2.00) and the risk difference was -0.03 (95% CI -0.17 to 0.12). The studies did not provide sufficient detail to determine which OHA(s) were associated with adverse neonatal outcomes. CONCLUSIONS: First-trimester exposure to OHAs did not significantly increase rates of major malformations or neonatal death. However, the studies were heterogeneous and care must be taken in interpreting the results. Further studies are needed to address the safety of OHAs in the first trimester with concomitant good glycemic control.
Abnormalities, Drug-Induced↗
Large errors in the dosing of medications for children.
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Child↗
Perinatal outcome following third trimester exposure to paroxetine.
BACKGROUND: Paroxetine hydrochloride is commonly used for maternal depression, panic disorder, and obsessive-compulsive disorder. The drug readily crosses the human placenta. Although it does not appear to increase teratogenic risk, there have been case reports of neonatal withdrawal. Symptoms were described soon after birth and lasted up to 1 month. OBJECTIVE: To investigate whether there is a clinically important discontinuation syndrome in neonates exposed to paroxetine in utero. METHODS: Prospective, controlled cohort study. PATIENTS: Fifty-five pregnant women counseled prospectively by the Motherisk program in Toronto, Ontario, regarding third-trimester exposure to paroxetine and their infants were included in the study group. Pregnant women who discontinued paroxetine before the third trimester or those receiving other drugs known to cause withdrawal-type symptoms, such as opioids or benzodiazepines, were excluded. A comparison group of 27 women using paroxetine during the first or second trimester and 27 women using nonteratogenic drugs were matched for maternal age, gravity, parity, social drug use, and nonteratogenic drug use. RESULTS: Of the 55 neonates exposed to paroxetine in late gestation, 12 had complications necessitating intensive treatment and prolonged hospitalization. The most prevalent clinical picture was respiratory distress (n = 9), followed by hypoglycemia (n = 2), and jaundice (n = 1). The symptoms disappeared within 1 to 2 weeks. In the comparison group, only 3 infants experienced complications (P =.03). In logistic regression, only third-trimester exposure to paroxetine was associated with neonatal distress (odds ratio, 9.53; 95% confidence interval, 1.14-79.3). CONCLUSION: When used near term, paroxetine is associated with a high rate of neonatal complications, possibly caused by its common discontinuation syndrome.
Adult↗
Aspirin consumption during the first trimester of pregnancy and congenital anomalies: a meta-analysis.
OBJECTIVE: The purpose of this study was to determine, on the basis of published reports, whether aspirin use during the first trimester of pregnancy is associated with an increased risk of congenital malformations. STUDY DESIGN: We reviewed the literature for published studies that reported exposure to aspirin during the first trimester of pregnancy and congenital malformations. Two reviewers independently determined whether a study should be included in the final analysis and extracted the data. We calculated the pooled odds ratio and 95% CI. RESULTS: Twenty-two studies met the inclusion criteria. In the eight studies that reported an overall risk, the risk of congenital malformations in offspring of women who were exposed to aspirin was not significantly higher than that in control subjects (odds ratio, 1.33; 95% CI, 0.94-1.89). However, a significantly increased risk of gastroschisis (odds ratio, 2.37; 95% CI, 1.44-3.88) was found. CONCLUSION: We found no evidence of an overall increase in the risk of congenital malformations that could be associated with aspirin. Aspirin exposure during the first trimester may be associated with an increased risk of gastroschisis.
Abnormalities, Drug-Induced↗
How high can we go with phenytoin?
Phenytoin is an effective anticonvulsant, but high serum phenytoin concentrations may be associated with serious toxicity. The upper limit for the therapeutic serum concentration of phenytoin is considered to be 80 micromol/L. However, in some situations higher serum concentrations are needed to control seizures. The authors describe a 9-year-old girl who needed concentrations twice the normal amount to control recurrent episodes of decreased levels of consciousness. Except for nystagmus, she had no other signs of phenytoin toxicity. This patient highlights the critical principle in therapeutic drug monitoring of individualizing drug therapy. Although some patients receiving phenytoin may achieve seizure control with "subtherapeutic" levels (i.e., <40 micromol/L), others may need supratherapeutic levels, as was the case with this patient. Clinicians should be careful not to treat "numbers" (i.e., serum concentrations), but rather the patient's clinical condition, with a careful balance between therapeutic advantage and adverse effects.
Anticonvulsants↗
Comparison of oral versus normal and high-dose rectal acetaminophen in the treatment of febrile children.
OBJECTIVES: To compare the defervescent effect of high-dose rectal suppository acetaminophen with the recommended oral and rectal dosages and to evaluate acceptability of rectal acetaminophen. METHODS: A randomized, controlled trial was performed in 70 patients aged 6 months to 6 years with fever > or =39 degrees C. Group A received rectal acetaminophen 15 mg/kg, group B received rectal acetaminophen 30 mg/kg, and group C received oral acetaminophen 15 mg/kg. Primary outcome was maximal change in temperature during the 3-hour study period after initial treatment. RESULTS: There were 24 patients in group A, 23 in group B, and 23 in group C. There was no significant difference in temperature change between the groups during the 3 hours or in the maximum drop in temperature or final temperature. Visual analog scores for satisfaction of parents did not reveal any significant differences between the oral and rectal routes. CONCLUSIONS: There was no difference between the temperature decrement in patients treated with 15 mg/kg oral acetaminophen and the same or double dose rectally. Thus, there seems to be no evidence to support the use of higher doses of rectal acetaminophen for the treatment of fever in children. The rectal route proved to be as acceptable as the oral among parents.
Acetaminophen↗
Variables associated with medication errors in pediatric emergency medicine.
OBJECTIVE: Medication errors are a common cause of iatrogenic morbidity and mortality. The incidence of medication errors in pediatric emergency departments (EDs) has not been described. The objective of this study was to describe the incidence and type of drug errors in a pediatric ED and determine factors associated with risk of errors. METHODS: A retrospective cohort study was conducted of the charts of 1532 children who were treated in the ED of a pediatric tertiary care hospital during 12 randomly selected days from the summer of 2000. Two pediatricians, blinded to other study variables, independently decided whether a medication error occurred and ranked it according to a severity score. Disagreement was resolved by consensus. RESULTS: Prescribing errors were identified in 10.1% of the charts. The following variables were associated in univariate analysis with an increased proportion of errors: patients seen between 4 AM and 8 AM (odds ratio [OR]: 2.45; 95% confidence interval [CI]: 1.10-5.50), patients with severe disease (OR: 2.53; 95% CI: 1.18-5.41), medication ordered by a trainee (OR: 1.48; 95% CI: 1.03-2.11), and patients seen during weekends (OR: 1.48; 95% CI: 1.04-2.11). Among trainees, there was a higher rate of errors at the beginning of the academic year (OR: 1.67; 95% CI: 1.06-2.64). Logistic regression revealed increased risk for errors when a medication was ordered by a trainee (OR: 1.64; 95% CI: 1.06-2.52) and in seriously ill patients (OR: 1.55; 95% CI: 1.06-2.26). CONCLUSIONS: In the pediatric ED, trainees are more likely to commit prescribing errors, and the most seriously ill patients are more likely to be subjected to prescribing errors.
Child↗
Approaches toward repeated supratherapeutic doses of paracetamol in children: a survey of medical directors of poison centres in North America and Europe.
BACKGROUND: During the last few years there has been an increase in the number of reports of liver failure associated with prolonged paracetamol (acetaminophen) administration in children for therapeutic reasons. OBJECTIVE: To describe the approach taken by medical directors of poison centres regarding the treatment of repeated supratherapeutic doses of paracetamol in children. METHODS: Questionnaires mailed to the medical directors of 76 poison centres in North America and 48 poison centres in Europe asked respondents to comment on the management of a hypothetical case of a child who had received repeated doses of paracetamol at a daily dose of 90 mg/kg during a febrile illness and who presented to the emergency department with mildly elevated serum transaminase levels. RESULTS: The response rate was 62% for North American centres and 44% for European centres. There was a wide range of answers regarding the maximal safe daily dose of paracetamol. For the case described, 71% of the respondents suggested measuring paracetamol serum concentration. Fifty-four percent suggested treating the patient with acetylcysteine and 35% suggested not treating the patient. CONCLUSIONS: Our study showed that there is little agreement among medical directors of poison centres on the toxic threshold for chronic exposure to paracetamol in children and on how these cases should be managed.
Acetaminophen↗
A prospective study of multiple supratherapeutic acetaminophen doses in febrile children.
Repeated doses of acetaminophen given for therapeutic reasons have been reported to cause hepatotoxicity in adults and children. We studied the effect of repeated acetaminophen (APAP) overdoses administered for therapeutic purposes in a prospective cohort of children. Forty-four children, aged 2 mo to 10 y were referred with a fever of >38.5 C for more than 48 h, and received >60 mg APAP/kg/d. In each patient AST, ALT and APAP blood levels were measured. The mean total daily dose of APAP was 92+/-26 (63-171) mg/kg. There was a weak, but significant, negative correlation between age and daily dose of APAP where younger children received higher doses of APAP. In 4 children (9.1%) an elevation of AST and ALT was found. Three of the 4 patients with elevated liver enzymes had received >90 mg APAP/kg/day; APAP blood levels ranged from 0 to 23 mg/mL. No correlation was found between the time since last APAP dose and the serum drug level. Ill children receiving repeated supratherapeutic doses of acetaminophen may show abnormalities in liver function. However, severe liver injury was rare.
Acetaminophen↗
Resting energy expenditure in children with cyanotic and noncyanotic congenital heart disease before and after open heart surgery.
BACKGROUND: Failure to thrive is a common problem in children with congenital heart disease (CHD). Resting energy expenditure (REE) in cyanotic and noncyanotic children with CHD before and after open heart surgery has hardly been investigated. METHODS: Twenty-nine children younger than 3 years of age with CHD (14 cyanotic and 15 noncyanotic CHD) who were referred for open heart surgery were enrolled. Data on dietary intake, anthropometric measurements, and indirect calorimetry parameters were measured 24 hours before the surgery, (day -1), and on day 5 after surgery. The measured REE was compared with the Schofield and World Health Organization (WHO) REE prediction equations. RESULTS: The mean +/- SD measured REE was similar in the cyanotic and noncyanotic children before and after surgery (before surgery: 57 +/- 13 and 58 +/- 9 kcal/kg per day, respectively; 5 days after surgery: 59 +/- 10 and 62 +/- 10 kcal/kg per day, respectively). Oxygen consumption (VO2) and carbon dioxide production (VCO2) did not change significantly before and after surgery and were similar in both groups. The measured REE for all children on day -1 and day 5 was similar to the calculated REE using the Schofield equation but was significantly different from the calculated REE using the WHO equation (p < .01). CONCLUSIONS: Significant changes in REE, VCO2, and VO2 were not observed before and 5 days after open heart surgery in children with CHD. These parameters (REE, VCO2, and VO2) were also similar in children with cyanotic versus noncyanotic CHD. The Schofield equation is more accurate than the WHO equation in predicting energy needs of children with CHD, but measurement of REE is preferred over calculation of REE.
Calorimetry, Indirect↗