PubMed Health⌕ Search

Biomedical subjects

A Taddio

Publications and source records attributed to A Taddio.

28 records · Page 2Linked to original sources

Safety of metronidazole in pregnancy: a meta-analysis.

OBJECTIVE: Our purpose was to determine from published experience in humans whether metronidazole exposure during the first trimester of pregnancy is associated with an increased teratogenic risk. STUDY DESIGN: All published articles reporting on metronidazole use during pregnancy were screened by two independent reviewers to select those including pregnant patients exposed during the first trimester and comparing the outcomes of their pregnancies with that of patients either not exposed to metronidazole or exposed only during the third trimester. The outcome under consideration was the occurrence of birth defects in live-born infants. The overall odds ratios of first-trimester exposure versus no first-trimester exposure was calculated by combining the selected studies in a meta-analysis according to the procedure of Mantel and Haenszel. RESULTS: From 32 identified studies, 7 met the inclusion criteria for meta-analysis. Six were prospective and included 253 women exposed to the drug in the first trimester of pregnancy; one was retrospective and reported on 1083 exposed women. The overall weighted odds ratio of exposure versus no exposure during the first trimester calculated by meta-analysis of the 7 studies was 0.93 (95% confidence interval 0.73 to 1.18). The odds ratio calculated from the 6 prospective studies was 1.02 (95% confidence interval 0.48 to 2.18). CONCLUSION: Metronidazole does not appear to be associated with an increased teratogenic risk.

Abnormalities, Drug-Induced↗

A revised measure of acute pain in infants.

Acute pain in infants is not assessed or managed optimally. The objectives of the study were (a) to adapt a behavioral pain assessment measure (Children's Hospital of Eastern Ontario Pain Scale, CHEOPS) for use with infants, and (b) to establish the reliability and validity of the measure in a study of infants undergoing immunization. Ninety-six healthy 4- to 6-month-old infants were randomized to receive either the local anesthetic cream Eutectic Mixture of Local Anesthetics (EMLA) (N = 49), or a placebo (N = 47) prior to immunization. The infant's behavioral response was videotaped immediately before and following the immunization. Postprocedural pain scores were assessed from the videotape and were significantly lower in infants who received EMLA (P = 0.01). Pain scores were also significantly correlated with visual analogue scale (VAS) scores assessed during vaccination. Five independent raters also independently rated ten infants to determine interrater reliability. Agreement between raters' scores was high (intraclass correlation coefficient, 0.95). Results from this study suggest that this measure has beginning construct and concurrent validity and interrater reliability when used in a research study. Further testing of the measure in the clinical setting is required.

Acute Disease↗

Safety of lidocaine-prilocaine cream in the treatment of preterm neonates.

The safety of lidocaine-prilocaine cream (EMLA) was evaluated in an open trial in 30 preterm neonates (mean gestational age, 32.8 weeks; birth weight, 1911 gm); 0.5 gm was applied to the heel for 1 hour. Mean baseline and follow-up (4, 8, or 12 hours after EMLA application) methemoglobin levels were not different, ranging from 1.15% to 1.45%, and from 1.13% to 1.49%, respectively.

Analgesics↗

Penile absorption of EMLA cream in piglets: implications for use of EMLA in neonatal circumcision.

EMLA (eutectic mixture of lidocaine and prilocaine) cream is currently not recommended for use in infants < 1 month of age because of the potential risk of methemoglobinemia as a result of the o-toluidine metabolite of prilocaine. We studied bioavailability and changes in methemoglobin levels following topical penile exposure to 1 g of EMLA cream for 1 hour in piglets. Lidocaine, prilocaine, and o-toluidine concentrations were measured simultaneously using a high-performance liquid chromatography method. The systemic bioavailability of EMLA was low: 4.0 +/- (SD) 4.7% for lidocaine (range 0-13.6; n = 8) and 7.2 +/- 5.7% for prilocaine (range 0-14.5; n = 8). The ratio between exposure to o-toluidine with EMLA versus intravenous administration (i.e., AUCEMLA/AUCIV; see text) was also low: 4.2 +/- 9.3% (range 0-28.6; n = 9). The mean maximum methemoglobin value after intravenous administration was 1.23 +/- 0.64% (range 0.5-3.0; n = 12) and after penile application 0.99 +/- 0.36% (range 0.5-2.0; n = 12). The methemoglobin value was elevated significantly above baseline after intravenous administration (p = 0.03), but not after penile application of EMLA. These findings suggest that penile administration of 1 g of EMLA may be safe for neonatal circumcision, but further study is required.

Absorption↗

Quality of nonstructured and structured abstracts of original research articles in the British Medical Journal, the Canadian Medical Association Journal and the Journal of the American Medical Association.

OBJECTIVE: To assess and compare the quality of nonstructured and structured abstracts of original research articles in three medical journals. DESIGN: Blind, criterion-based observational study. SAMPLE: Random sample of 300 abstracts (25 abstracts per journal each year) of articles published in the British Medical Journal (BMJ), the Canadian Medical Association Journal and the Journal of the American Medical Association (JAMA) in 1988 and 1989 (nonstructured abstracts) and in 1991 and 1992 (structured abstracts). MAIN OUTCOME MEASURES: The quality of abstracts was measured against 33 objective criteria, which were divided into eight categories (purpose, research design, setting, subjects, intervention, measurement of variables, results and conclusions). The quality score was determined by dividing the number of criteria present by the number applicable; the score varied from 0 to 1. RESULTS: The overall mean quality scores for nonstructured and structured abstracts were 0.57 and 0.74 respectively (p < 0.001). The frequency in meeting the specific criteria was generally higher for the structured abstracts than for the nonstructured ones. The mean quality score was higher for nonstructured abstracts in JAMA than for those in BMJ (0.60 v. 0.54, p < 0.05). The scores for structured abstracts did not differ significantly between the three journals. CONCLUSIONS: The findings support recommendations that promote the use of structured abstracts. Further studies should be performed to assess the effect of time on the quality of abstracts and the extent to which abstracts reflect the content of the articles.

Abstracting and Indexing↗

Use of lidocaine-prilocaine cream for vaccination pain in infants.

PURPOSE: To determine whether use of lidocaine-prilocaine 5% cream (EMLA) decreases pain associated with diphtheria-pertussis-tetanus (DPT) vaccination in infants. METHODS: Randomize, double-blind, controlled trial in outpatient pediatric practice, Toronto, Ontario, Canada. Before vaccination, parents applied 2.5 gm of EMLA or placebo to the infant's leg and covered it with an occlusive dressing for at least 60 minutes. The infant received a 0.5 ml intramuscular injection of DPT at 2 degree to 8 degree C with a 1.6 cm 25-gauge needle; the infant was videotaped. The Modified Behavioral Pain Scale (MBPS) was used to assess baseline and postvaccination pain scores. Latency and duration of infant cry were also measured. RESULTS: A total of 49 evaluable infants received EMLA, and 47 infants received placebo. There were no significant differences in demographic data; mean age was 5 months; and 50% of the subjects were male. The median difference in pre-vaccination and postvaccination MBPS scores was lower for EMLA than for placebo (p = 0.001). The latency to the first cry was longer for subjects who were treated with EMLA (p = 0.0004)), but the total crying time was shorter (10.3 seconds vs 25.2 seconds; p = 0.027). Of the study group, 90% (45/50) of subjects treated with EMLA and 12% (6/49) of subjects treated with placebo had local skin reactions (p < 0.0001), mainly skin blanching. CONCLUSIONS: Pretreatment with EMLA decreases infant pain from DPT vaccinations. Application of these data is limited to healthy infants receiving DPT vaccinations.

Anesthetics, Local↗

Acyclovir excretion in human breast milk.

OBJECTIVE: To measure acyclovir concentrations in the breast milk of a lactating woman using the drug for herpes zoster while nursing her 7-month-old infant. METHODS: The maternal dosage of acyclovir was 800 mg five times daily for seven days. Three random breast milk samples collected on the fifth and sixth days of therapy were analyzed for acyclovir concentrations with radioimmunoassay (RIA). RESULTS: Acyclovir concentrations in breast milk ranged from 18.5 mumol (4.16 micrograms/mL) to 25.8 mumol (5.81 micrograms/mL). An estimate of the infant's dosage ingested through nursing was 0.73 mg/kg/d, or approximately 1 percent of the maternal dose in milligrams/kilograms/day. The baby was nursed without any signs of adverse effects. CONCLUSIONS: Acyclovir was measured in clinically insignificant concentrations in the milk of a woman receiving large dosages for herpes zoster. Breast feeding continued without adverse effects to the nursing infant.

Acyclovir↗

Bulk compounding in Canadian hospitals--a survey.

A five-page English survey was mailed to 350 Canadian hospitals with 100+ beds to identify aspects of pharmacy bulk compounding services. The survey used open-ended questions to determine demographic and background information of the hospitals surveyed, availability of bulk compounding services and associated personnel requirements, products and dosage forms compounded, and compliance with "CSHP Guidelines for Bulk Compounding of Products in Hospitals". A 47.4 percent response rate was achieved. Sixty-six percent of respondents provided bulk compounding services. Proportionately, teaching hospitals were more likely to compound (84.6%) than other types of hospitals. Hospitals with 400+ beds were more likely to compound (85.7%) than hospitals with less than 400 beds (55.7%). No pattern was determinable for personnel requirements necessary for bulk compounding services. Items compounded most frequently were topical (80%) or oral (79.1%) preparations. Dosage forms most likely to be compounded were solutions (81.8%), ointments (69.1%) and suspensions (68.2%). Cocaine solution was the most commonly prepared product (47.3%). Compliance with CSHP standards was generally good (50-90%).

Canada↗

Effect of counseling on maternal reporting of adverse effects in nursing infants exposed to antibiotics through breast milk.

In a recent trial, we found that nursing women reported diarrhea in their nursing infants after maternal use of antibiotics. However, because they were told that this could occur during a medication counseling session, the observed effect could have been due to a reporting bias. The objectives of this study were to determine if counseling nursing women about side effects of antibiotic they used could (a) influence the adverse event reporting rate or (b) influence maternal nursing and medication compliance behavior. In a randomized, controlled trial, nursing women calling a teratogen information service for advice about selected antibiotics received one of two possible counseling formats (A and B). Both groups were informed that the antibiotics were safe to use. Mothers in group B were also informed about a theoretical risk of diarrhea in the infant. Mothers later reported clinical events they noted in the infants and judged whether they were due to the antibiotic. Eighty-seven percent (54/62) of group A subjects compared to 68% (52/76) of group B subjects reported clinical events in their infants during their antibiotic therapy (P = 0.017). The incidence of reported diarrhea was 26% in group A compared to 17% in group B (P = 0.3); 34% of subjects in both groups attributed clinical events to antibiotic therapy (P = 1.0). Diarrhea was attributed to antibiotic therapy in 13% of group A and 12% of group B subjects (P = 1.0). No differences were observed between groups in breastfeeding pattern and antibiotic compliance. Breastfeeding women counseled about adverse effects were not more likely to report side effects in their infants or to change nursing behavior and medication compliance.

Adverse Drug Reaction Reporting Systems↗