Search PubMed⌕ Search

Biomedical subjects

G Koren

Publications and source records attributed to G Koren.

At least 235 records · Page 13Linked to original sources
PubMed1997

Efficacy and safety of lidocaine-prilocaine cream for pain during circumcision.

BACKGROUND: Neonatal circumcision is a painful surgical procedure often performed without analgesia. We assessed the efficacy and safety of 5 percent lidocaine-prilocaine cream (Emla) in neonates undergoing circumcision. METHODS: We carried out a double-blind, randomized, controlled trial in 68 full-term male neonates: 38 were assigned to receive lidocaine-prilocaine cream, and 30 to receive placebo. One gram of lidocaine-prilocaine or placebo cream was applied to the penis under an occlusive dressing for 60 to 80 minutes before circumcision. Behavioral (facial activity and time spent crying) and physiologic (heart rate and blood pressure) responses were recorded during the procedure. Blood samples were obtained at various times after drug application for measurements of methemoglobin and plasma lidocaine, prilocaine, and o-toluidine (a metabolite of prilocaine). RESULTS: A total of 68 and 59 neonates were included in the safety and efficacy analyses, respectively. Demographic characteristics such as gestational age and birth weight did not differ between the lidocaine-prilocaine and placebo groups. During circumcision, the neonates in the lidocaine-prilocaine group had less facial activity (P= 0.01), spent less time crying (P<0.001), and had smaller increases in heart rate (P=0.007) than the neonates in the placebo group. Facial-activity scores were 12 to 49 percent lower during various steps of the procedure in the lidocaine-prilocaine group. As compared with neonates in the placebo group, infants in the lidocaine-prilocaine group cried less than half as much and had heart-rate increases of 10 beats per minute less. Blood methemoglobin concentrations (expressed as a percentage of the hemoglobin concentration) were similar (1.3 percent) in both groups. Lidocaine and prilocaine were detected in plasma in 23 (61 percent) and 21 (55 percent) of the infants treated with lidocaine-prilocaine cream, respectively. CONCLUSIONS: Lidocaine-prilocaine cream is efficacious and safe for the prevention of pain from circumcision in neonates.

Anesthesia, Local↗
PubMed1997

Characteristics of pregnant women who engage in binge alcohol consumption.

OBJECTIVE: To characterize pregnant women who engage in binge drinking and to identify other risk behaviour that these women engage in. DESIGN: Observational study based on retrospective review of records. SETTING: A telephone and outpatient counselling service in Toronto that advises pregnant women about exposure to drugs, chemicals, radiation and infections during pregnancy and lactation. PARTICIPANTS: All pregnant women who sought counselling concerning fetal risk of exposure to binge drinking from 1985 to 1994 as well as those counselled by telephone from 1993 to 1994, and an equal number of control women who sought counselling. OUTCOME MEASURES: Information about binges, demographic factors, history of elective and spontaneous abortion, and use of psychotropic drugs and cigarettes as well as marijuana, cocaine and other illicit drugs. RESULTS: Of the 3800 women seen in the clinic, 119 (3.1%) reported binge drinking during pregnancy; of the 19,991 women counselled by telephone, 153 (0.8%) reported binge drinking during pregnancy. The mean number of drinks per binge was 7.2 (standard deviation 2.5). None of the women was an alcoholic; 83.1% had binged fewer than 10 times during their pregnancy. A large majority (84.0%) of the women had a binge early in the first trimester (before 6 weeks' gestation). In comparison with control women, the women who had engaged in binge drinking were significantly younger (mean 30.0 v. 27.9 years, p < 0.0001) and more likely to be single (12.2% v. 54.6%, p < 0.0001), to be white (69.2% v. 92.9%, p < 0.004), to smoke (19.3% v. 57.1%, p < 0.0001) and to use cocaine (1.1% v. 11.0%, p < 0.0001), marijuana (3.0% v. 19.3%, p < 0.0001) and other illicit drugs (0.7% v. 9.2%, p < 0.0001). CONCLUSIONS: Pregnant women who report binge alcohol consumption often report use of cigarettes, cocaine, marijuana and other illicit drugs as well, all of which represent a significant risk to the fetus. Rigorous efforts should be made to prevent the socially accepted binge consumption of alcohol among young, sexually active women.

Adult↗
PubMed1997

Effect of neonatal circumcision on pain response during subsequent routine vaccination.

BACKGROUND: Preliminary studies suggested that pain experienced by infants in the neonatal period may have long-lasting effects on future infant behaviour. The objectives of this study were to find out whether neonatal circumcision altered pain response at 4-month or 6-month vaccination compared with the response in uncircumcised infants, and whether pretreatment of circumcision pain with lidocaine-prilocaine cream (Emla) affects the subsequent vaccination response. METHODS: We used a prospective cohort design to study 87 infants. The infants formed three groups--uncircumcised infants, and infants who had been randomly assigned Emla or placebo in a previous clinical trial to assess the efficacy of Emla cream as pretreatment for pain in neonatal circumcision. Infants were videotaped during vaccination done at the primary care physician's clinic. Videotapes were scored without knowledge of circumcision or treatment status by a research assistant who had been trained to measure infant facial action, cry duration, and visual analogue scale pain scores. FINDINGS: Birth characteristics and infant characteristics at the time of vaccination, including age and temperament scores, did not differ significantly among groups. Multivariate ANOVA revealed a significant group effect (p < 0.001) in difference (vaccination minus baseline) values for percentage facial action, percentage cry time, and visual analogue scale pain scores. Univariate ANOVAs were significant for all outcome measures (p < 0.05): infants circumcised with placebo had higher difference scores than uncircumcised infants for percentage facial action (136.9 vs 77.5%), percentage cry duration (53.8 vs 24.7%), and visual analogue scale pain scores (5.1 vs 3.1 cm). There was a significant linear trend on all outcome measures, showing increasing pain scores from uncircumcised infants, to those circumcised with Emla, to those circumcised with placebo. INTERPRETATION: Circumcised infants showed a stronger pain response to subsequent routine vaccination than uncircumcised infants. Among the circumcised group, preoperative treatment with Emla attenuated the pain response to vaccination. We recommend treatment to prevent neonatal circumcision pain.

Analysis of Variance↗
PubMed1997

Modeling supra-molecular helices: extension of the molecular surface recognition algorithm and application to the protein coat of the tobacco mosaic virus.

Geometric matching of molecular surfaces appears to be essential for the formation of binary molecular complexes and of supra-molecular aggregates. The structure of a binary complex is characterized by the best geometric match, whereas the structure of an aggregate is characterized by the best combined match, i.e. the sum of all the internal matches in the system. We describe a method to identify and quantify the binary matches between molecules and then use them to form the supra-molecular helices and evaluate them. This method is applied to the single protein subunit of tobacco mosaic virus. It successfully predicts the structure of the helical protein coat of the virus and the structure of the disk that is formed as the initial step in the virus assembly process. It also predicts structural intermediates, between disk and helix, which explain how the disk can transform into a helix without dissociating into subunits.

Algorithms↗
PubMed1997

Neurodevelopment of children exposed in utero to antidepressant drugs.

BACKGROUND: Many women of reproductive age have depression, necessitating therapy with either a tricyclic antidepressant drug or a drug, such as fluoxetine, that inhibits the reuptake of serotonin. Whether these drugs affect fetal neurodevelopment is not known. METHODS: We studied the children of 80 mothers who had received a tricyclic antidepressant drug during pregnancy, 55 children whose mothers had received fluoxetine during pregnancy, and 84 children whose mothers had not been exposed during pregnancy to any agent known to affect the fetus adversely. The children's global IQ and language development were assessed between 16 and 86 months of postnatal age by age-appropriate Bayley Scales of Infant Development or the McCarthy Scales of Children's Abilities (for IQ) and the Reynell Developmental Language Scales. RESULTS: The mean (+/-SD) global IQ scores were 118+/-17 in the children of mothers who received a tricyclic antidepressant drug, 117+/-17 in those whose mothers received fluoxetine, and 115+/-14 in those in the control group. The language scores were similar in all three groups. The results were similar in children exposed to a tricyclic antidepressant drug or fluoxetine during the first trimester and those exposed throughout pregnancy. There were also no significant differences in temperament, mood, arousability, activity level, distractibility, or behavior problems in the three groups of children. CONCLUSIONS: In utero exposure to either tricyclic antidepressant drugs or fluoxetine does not affect global IQ, language development, or behavioral development in preschool children.

Adult↗
PubMed1997

Findings in children exposed in utero to phenytoin and carbamazepine monotherapy: independent effects of epilepsy and medications.

Our objective was to evaluate the patterns of malformations in children exposed in utero to phenytoin (DPH) and carbamazepine (CBZ) monotherapy, and to compare them prospectively with matched mother-child pairs exposed to nonteratogens, and to separate the effects of antiepileptic drugs (AEDs) from those of epilepsy by collecting groups of untreated epileptics and those treated with DPH and CBZ for conditions other than epilepsy. This was a prospective, controlled, and blinded observational study. Thirty-six mother-child pairs exposed to CBZ monotherapy, 34 pairs exposed to DPH monotherapy, and 9 nonmedicated epileptic women and their children were compared with matched mother-child pairs exposed to nonteratogens. The control mothers were matched for maternal age, time of consultation, obstetric history, and socioeconomic status (SES). One main outcome measures a "blinded" morphological assessment of the offspring. We found that minor anomalies were significantly more common among children of epileptics on either drug (P = 0.01) and among DPH-treated nonepileptic offspring (P = 0.03). Among epileptics, the relative risk for minor anomalies following DPH (2.1) was similar to that after exposure to either DPH (P = 0.006) or CBZ (P = 0.01). Increased rates of hypertelorism were detected among DPH-exposed offspring. High forehead, frontal bossing, malar hypoplasia, epicanthus and micrognathia were associated with untreated epilepsy, as well as with DPH and CBZ treatment.

Adult↗
PubMed1997

Compliance with cyclosporine in adolescent renal transplant recipients.

Inadequate compliance with prescribed medication regimens in children is complex and poorly understood. We measured the extent and pattern of noncompliance with cyclosporine in our adolescent renal transplant population and attempted to determine factors associated with poor compliance. After informed consent, each patient was provided cyclosporine capsules in a medication bottle equipped with an electronic monitoring device (MEMS-4) in the lid. Of the 24 patients eligible, 19 patients (8 female, 11 male) completed the study. Four (21%) patients took less than 80% of the prescribed cyclosporine doses. Five (26%) patients took drug holidays involving > or = consecutive doses. There was a trend towards improved compliance with the evening dose (88.5% vs. 93.4%, P = 0.09) and a downward trend in compliance over the course of the study (P = 0.17). None of the variables tested were found to be associated with noncompliance. Experienced physicians and nurses were able to identify 2 of the 4 individuals who were identified by MEMS as noncompliant. Additionally, 2 of the 4 noncompliance patients demonstrated low cyclosporine trough levels (< 50 ng/ml). Noncompliance with cyclosporine regimens occurs commonly in adolescent renal transplant recipients. Unexpectedly low cyclosporine levels are strongly suggestive of noncompliance, whereas other variables, including prediction by physicians and nurses intimately involved in the care, were not reflective of noncompliance.

Adolescent↗
PubMed1997

Accidental electric shock in pregnancy: a prospective cohort study.

OBJECTIVE: Our purpose was to quantify fetal risk after accidental electric shock in pregnancy. STUDY DESIGN: All pregnant women who were counseled by the Motherisk Program in Toronto and by the Vermont Pregnancy Risk Information Service in Burlington after having an electric shock during pregnancy were enrolled in a prospective, controlled, observational study. RESULTS: Thirty-one women were followed up after delivery: 26 had been exposed to 110 V, 2 to 220 V, 2 to high voltage, and 1 to 12 V. Twenty-eight women gave birth to healthy normal infants, one had a child with a ventricular septal defect, and two had spontaneous abortions. In the control group there were 30 healthy babies; one woman had a spontaneous abortion. There were no differences between the groups in pregnancy outcome, birth weight, gestational age, type of delivery, or rates of neonatal distress. CONCLUSION: In most cases accidental electric shock occurring during day-to-day life during pregnancy does not pose a major fetal risk.

Abortion, Spontaneous↗
PubMed1997

Noninvasive methods for drug measurement in pediatrics.

Infants and children present a special challenge to drug monitoring because the disposition of drugs differs from adults and because there are far fewer clinical studies designed for children than for adults. The excuse for this unfortunate situation is the imposition of severe technical and ethical constraints caused by blood sampling; however, in the past two decades, several new noninvasive methods to measure drugs have been tested and implemented in therapeutic drug monitoring. It is our hope that these new techniques will help advance the ability to diagnose and manage infants and young children.

Adolescent↗
PubMed1997

Oral iron chelation with deferiprone.

Deferiprone is the most widely studied oral iron chelator and, at present, the only one shown to be effective in achieving negative iron balance in long-term clinical trials for chronic iron overload. Because of its adverse effects (e.g., agranulocytosis and arthropathy) its use is presently restricted to clinical trials and to countries where desferrioxamine is unavailable. Deferiprone was licensed for clinical use in India in 1995. Clinical trials are in progress in many centers worldwide that will provide further information on the long-term effectiveness of deferiprone as well as on the incidence of serious adverse effects in patients with iron overload. Trials of combined use of deferiprone and desferrioxamine are also in progress. In the meantime, deferiprone is an acceptable alternative for patients who cannot use desferrioxamine because of serious adverse effects, lack of compliance, or unavailability. Elucidation of the mechanisms involved in the agranulocytosis and arthropathy associated with deferiprone is still needed, as are methods to predict individual susceptibility to these adverse effects and ways of preventing them. In addition, new indications for iron-chelating therapy are continuously being explored.

Acute Disease↗
PubMed1997

Counseling sexually active teenagers treated with potential human teratogens.

Adolescents with hemoglobinopathies need daily chelation therapy with drugs which are known or suspected to be teratogenic. The prevention of fetal exposure to such drugs is therefore a major task for health professionals caring for these patients. We describe a pilot program aiming to prevent pregnancy among sexually active adolescents treated with iron chelators in Toronto. Most of them had normal response to GnRH, suggesting endocrinologic fertility, and unlike the literature concerning their healthy peers, all sexually active patients in this study reported use of at least one form of contraception.

Adolescent↗
PubMed1997

Prospective controlled study of hydroxyzine and cetirizine in pregnancy.

BACKGROUND: Hydroxyzine has been used for many years for the treatment of allergic symptoms. Cetirizine, an active metabolite of hydroxyzine, has become very popular for the treatment of allergy symptoms because of its efficacy without the sedating effects of the parent compound. Little is known about the safety of hydroxyzine use during pregnancy, and there are no published reports on the effects of cetirizine on pregnancy outcome. OBJECTIVE: To determine whether hydroxyzine and cetirizine are associated with any increased risk of malformations in humans. METHODS: All pregnant women counseled by the Motherisk Program in Toronto on the use of hydroxyzine or cetirizine during their pregnancies were enrolled in a prospective, controlled, observational study. The control group consisted of pregnant women matched for age, smoking, and alcohol consumption who were counseled for non-teratogenic drug. RESULTS: One hundred twenty women were followed after exposure to either hydroxyzine or cetirizine during pregnancy. Of these, 53 were exposed to hydroxyzine during organogenesis and 39 to cetirizine. There were no significant differences found between the hydroxyzine or cetirizine groups and the control groups in the pregnancy outcome: rate of livebirths, spontaneous or therapeutic abortion, or stillbirth. There was also no difference in the rates of major or minor anomalies, mean birth weight, mode of delivery, gestational age, or presence of neonatal distress. CONCLUSIONS: The use of hydroxyzine and cetirizine does not appear to be associated with increased teratogenic risk.

Abortion, Spontaneous↗
PubMed1997

Cisapride use during human pregnancy: a prospective, controlled multicenter study.

The objective of this prospective multicenter study was to determine whether cisapride is associated with increased risk of malformations, spontaneous abortions, or decreased birthweight when used during pregnancy. Cases were paired for age, smoking, and alcohol consumption with controls exposed to nonteratogens, as well as with disease-paired controls. One hundred and twenty-nine pregnant women were exposed to cisapride during pregnancy, including 88 during the period of fetal organogenesis. There were no differences in maternal history, birthweight, gestational age at delivery, and rates of livebirths, spontaneous or therapeutic abortions, fetal distress, and major or minor malformations among groups. It is concluded that exposure to cisapride during pregnancy is not associated with a major increased risk of malformations or spontaneous abortions or with decreased birthweight.

Abnormalities, Drug-Induced↗