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At least 1,189 records · Page 66Linked to original sources
PubMed2002

Is roxithromycin better than amoxicillin in the treatment of acute lower respiratory tract infections in primary care? A double-blind randomized controlled trial.

OBJECTIVE: To assess the efficacy of roxithromycin relative to amoxicillin. STUDY DESIGN: We conducted a double-blind randomized controlled trial of oral 500 mg amoxicillin 3 times per day vs oral 300 mg roxithromycin once a day for 10 days. POPULATION: We included 196 adults who had presented to a general practitioner with lower respiratory tract infection (LRTI) and, in the physician's opinion, needed antibiotic treatment. OUTCOMES MEASURED: We measured clinical response after 10 and 28 days, defined in 4 ways: (1) decrease in LRTI symptoms; (2) complete absence of symptoms; (3) decrease in signs; and (4) complete absence of signs. Self-reported response included the decrease in symptoms and the time until resumption of impaired or abandoned daily activities on days 1 through 10, 21, and 27. RESULTS: Clinical cure rates after the completion of antibiotic treatment (10 days) were not significantly different for the 2 groups. After 28 days, the roxithromycin group showed no increase in cure rate as evidenced by the decrease in symptoms, indicating a significantly lower cure rate. However, this difference did not alter physicians' overall conclusion after complete follow-up that 90% of patients, regardless of age, had been effectively treated with either amoxicillin or roxithromycin. CONCLUSIONS: The surplus value of roxithromycin was not confirmed. Amoxicillin remains a reliable first-choice antibiotic in the treatment of LRTI in general practice.

Adult↗
PubMed2002

Randomized controlled trials for evaluating surgical questions.

OBJECTIVE: To discuss some of the obstacles inherent in the design of the randomized controlled trial (RCT) that the surgeon must confront and options to minimize these obstacles. DATA SOURCES: The literature was searched for articles discussing RCTs using MEDLINE from 1966 to 1998. STUDY SELECTION: Studies relevant to the general use of RCTs for evaluating surgical questions were selected. SYNTHESIS: Several problems inherent in RCTs were noted: (1) ethical considerations, (2) difficulties in patient accrual, (3) patient preferences, and (4) variability in surgical proficiency/technique. Some means of minimizing these problems are (1) the concept of clinical equipoise, (2) multicenter trials, and (3) stratified sampling of patients. Alternatives to the classic RCT are discussed, namely, the randomized consent design and the patient preference design. CONCLUSIONS: The nature of the RCTs is that they are difficult to use to evaluate surgical techniques. Some options are available to minimize these difficulties. Designing and conducting RCTs to evaluate surgical interventions require careful planning and some compromises. Unless the previously mentioned criteria are applied, the validity of the RCT can be considered no greater than that of other trials.

Ethics, Medical↗
PubMed1999

Randomized controlled trial of a comprehensive stroke education program for patients and caregivers.

BACKGROUND AND PURPOSE: We report the findings of a randomized controlled trial to determine the effectiveness of a multidisciplinary Stroke Education Program (SEP) for patients and their informal carers. METHODS: Two hundred four patients admitted with acute stroke and their 176 informal carers were randomized to receive an invitation to the SEP or to receive conventional stroke unit care. The SEP consisted of one 1-hour small group educational session for inpatients followed by six 1-hour sessions after discharge. The primary outcome measure was patient- and carer-perceived health status (SF-36) at 6 months after stroke. Knowledge of stroke, satisfaction with services, emotional outcome, disability, and handicap and were secondary outcome measures. RESULTS: Only 51 of 108 (47%) surviving patients randomized to the SEP completed the program, as did 20 of 93 (22%) informal carers of surviving patients. Perceived health status (Short Form 36 [SF-36] health survey) scores were similar for SEP patients and controls. Informal carers in the control group scored better on the social functioning component of the SF-36 than the SEP group (P=0.04). Patients and informal carers in the SEP group scored higher on the stroke knowledge scale than controls (patients, P=0.02; carers, P=0. 01). Patients in the SEP group were more satisfied with the information that they had received about stroke (P=0.004). There were no differences in emotional or functional outcomes between groups. CONCLUSIONS: Although the SEP improved patient and informal carer knowledge about stroke and patient satisfaction with some components of stroke services, this was not associated with an improvement in their perceived health status. Indeed, the social functioning of informal carers randomized to the SEP was less than in the control group.

Adult↗
PubMedDate not supplied

Randomized controlled trials of 5- and 14-days primaquine therapy against relapses of vivax malaria in an Afghan refugee settlement in Pakistan.

Primaquine is the only drug available that can eliminate hypnozoites from the liver and prevent relapses of vivax malaria. The World Health Organization recommends a course of 14-21 days depending on region and strain. The National Malaria Control and Eradication Programmes of Pakistan and India have adhered to a 5-day course as their standard as it is deemed more practical to implement and because facility for detecting glucose 6-phosphate dehydrogenase (G6PD) deficiency is seldom available at the periphery. Evidence for the efficacy of the 5-day regimen is controversial or lacking. Two, year-long, randomized controlled trials were undertaken in an Afghan refugee camp in north-western Pakistan using a process of passive case detection and treatment at the camp's clinic: the first trial compared treatment with chloroquine alone versus chloroquine plus 5-days primaquine, the second trial compared chloroquine alone versus chloroquine plus 14-days primaquine. Chloroquine is not hypnozoitocidal and was administered to eliminate the erythrocytic stages and to alleviate clinical symptoms. The daily primaquine dose was 0.25 mg/kg bodyweight and the total chloroquine dose was 25 mg/kg over 3 days. During the first trial 52% (129/250) of the non-primaquine group recorded a 2nd clinical-parasitaemic episode and 23% recorded a 3rd, whereas 51% (128/250) of the 5-days primaquine group reported a 2nd episode and 21% recorded a 3rd. During the second trial 49% (49/100) of the non-primaquine group recorded a 2nd episode and 25% recorded a 3rd, whereas only 32% (32/100) of the 14-days primaquine group recorded a 2nd and only 2% recorded a 3rd. The 5-days primaquine regimen has no value as an anti-relapse therapy and should be abandoned. In extended tests in vivo in which vivax cases (n = 31) were treated with chloroquine 25 mg/kg and 14-days primaquine, there was no parasite recrudescence within 28 days and hence no evidence of resistance to chloroquine.

Adolescent↗
PubMed2000

A prospective, randomized controlled trial comparing the efficacy and safety of sotalol, amiodarone, and digoxin for the reversion of new-onset atrial fibrillation.

STUDY OBJECTIVE: A prospective, randomized controlled trial of new-onset atrial fibrillation was conducted to compare the efficacy and safety of sotalol and amiodarone (active treatment) with rate control by digoxin alone for successful reversion to sinus rhythm at 48 hours. METHODS: We prospectively randomly assigned 120 patients with atrial fibrillation of less than 24 hours' duration to treatment with sotalol, amiodarone, or digoxin using a single intravenous dose followed by 48 hours of oral treatment. Patients had ECG monitoring for 48 hours, and time of reversion, adequacy of rate control, and numbers of adverse events were compared. After 48 hours, those still in atrial fibrillation underwent cardioversion according to a standardized protocol. After 48 hours of therapy and attempted cardioversion, the number of patients whose rhythms had successfully reverted were compared. RESULTS: There was a significant reduction in the time to reversion with both sotalol (13. 0+/-2.5 hours, P <.01) and amiodarone (18.1+/-2.9 hours, P <.05) treatment compared with digoxin only (26.9+/-3.4 hours). By 48 hours, the active treatment group was significantly more likely to have reverted to sinus rhythm than the rate control group (95% versus 78%, P <.05; risk ratio 5.4, 95% confidence interval [CI] 1.5 to 19.2 ). In those patients whose rhythms did not revert to sinus rhythm, there was superior ventricular rate control in the sotalol group at both 24 and 48 hours compared with those who received either amiodarone or digoxin. There were also fewer adverse events in the active treatment group compared with the rate control group. CONCLUSION: Immediate pharmacologic therapy for new-onset atrial fibrillation with class III antiarrhythmic drugs (sotalol or amiodarone) improves complication-free 48-hour reversion rates compared with rate control with digoxin.

Aged↗
PubMed2001

A novel collagen-based composite offers effective hemostasis for multiple surgical indications: Results of a randomized controlled trial.

BACKGROUND: Intraoperative bleeding is ubiquitous during open surgical procedures and uniformly effective hemostasis remains elusive. We conducted a randomized controlled trial to determine the effectiveness of a novel collagen-based composite (CoStasis Surgical Hemostat) compared with standard methods of hemostasis during general, hepatic, cardiac, and orthopedic operations. METHODS: Hemostatic treatment was assigned randomly to 347 subjects; 318 subjects (167 CoStasis, 151 controls) underwent operation, received treatment, and provided hemostatic success data. CoStasis was applied to the bleeding site without manual pressure as a sprayable liquid composite of bovine microfibrillar collagen, bovine thrombin, and autologous plasma. Manual compression was used as the control hemostat. Hemostatic success was achieved if bleeding had ceased completely within 10 minutes (3 minutes for cardiac subjects). The time to controlled bleeding (ie, slight oozing) and time to complete hemostasis were recorded for all subjects. RESULTS: Hemostatic success was achieved in more than 90% (153/167) of CoStasis subjects compared with 58% (88/151) of control subjects (P =.01). Superior hemostatic effectiveness with CoStasis was realized in every surgical specialty: general (77/79 vs 49/75, P =.01), hepatic (38/39 vs 20/29, P =.01), cardiac (28/37 vs 17/37, P =.02), and orthopedic (10/12 vs 2/10, P =.01). The duration of bleeding was also significantly shorter with CoStasis. The median time to controlled bleeding (42 seconds vs 150 seconds, P =.0001) and time to complete hemostasis (75 seconds vs 252 seconds, P =.0001) were both markedly longer with the control intervention. There were no serious adverse events related to the use of CoStasis. CONCLUSIONS: CoStasis is more effective at controlling and stopping diffuse intraoperative bleeding than standard methods of hemostasis in 4 distinct surgical indications representing a wide variety of operative interventions.

Adult↗
PubMed2006

The impact of including husbands in antenatal health education services on maternal health practices in urban Nepal: results from a randomized controlled trial.

Observational studies suggest that including men in reproductive health interventions can enhance positive health outcomes. A randomized controlled trial was designed to test the impact of involving male partners in antenatal health education on maternal health care utilization and birth preparedness in urban Nepal. In total, 442 women seeking antenatal services during second trimester of pregnancy were randomized into three groups: women who received education with their husbands, women who received education alone and women who received no education. The education intervention consisted of two 35-min health education sessions. Women were followed until after delivery. Women who received education with husbands were more likely to attend a post-partum visit than women who received education alone [RR = 1.25, 95% CI = (1.01, 1.54)] or no education [RR = 1.29, 95% CI = (1.04, 1.60)]. Women who received education with their husbands were also nearly twice as likely as control group women to report making >3 birth preparations [RR = 1.99, 95% CI = (1.10, 3.59)]. Study groups were similar with respect to attending the recommended number of antenatal care checkups, delivering in a health institution or having a skilled provider at birth. These data provide evidence that educating pregnant women and their male partners yields a greater net impact on maternal health behaviors compared with educating women alone.

Adult↗
PubMed2002

Effect of delayed cord clamping on iron stores in infants born to anemic mothers: a randomized controlled trial.

OBJECTIVE: To study the effects of cord clamping on iron stores of infants born to anemic mothers at 3 months of age. DESIGN: Randomized controlled trial. SETTING: Teaching hospital. METHODS: Infants born to mothers with hemoglobin (Hb)<100 g/L were randomized at delivery to either immediate cord clamping (early group) or cord clamping delayed till descent of placenta into vagina (delayed group). The outcome measures were infant's hemoglobin and serum ferritin 3 months after delivery. RESULTS: There were 102 neonates randomized to early (n = 43) or delayed cord clamping (n = 59). The groups were comparable for maternal age, parity, weight and supplemental iron intake, infant s birth weight, gestation and sex. The mean infant ferritin and Hb at 3 months were significantly higher in the delayed clamping group (118.4 microg/L and 99 g/L) than in the early clamping group (73 microg/L and 88 g/L). The mean decrease in Hb (g/L) at 3 months adjusted for co-variates was significantly less in the delayed clamping group compared to the early clamping group (-1.09, 95% CI-1.58 to -0.62, p >0.001). The odds for anemia (<100 g/L) at 3 months was 7.7 (95% CI 1.84-34.9) times higher in the early compared to the delayed clamping group. CONCLUSION: Iron stores and Hb in infancy can be improved in neonates born to anemic mothers by delaying cord clamping at birth.

Adult↗
PubMed2005

A comparison of response rate and time according to the survey methods used: a randomized controlled trial.

The purpose of this study was to evaluate the effects of recorded and standard deliveries, and stamped and franked return envelops in a postal survey of Korean-Vietnam veterans. Nine hundred veterans were randomly divided into four subgroups. A randomized controlled trial was conducted for two mailing strategies. The 52 study subjects to whom mail was undeliverable and 36 additional study subjects found not to be residing at the listed addresses were excluded from the study. The 699 (86%) surveys were returned within 39 business days after the first mailing. The response rate for the recorded delivery (88%) was significantly higher than that of the standard delivery (82%)(p = 0.03), and the response rate of the stamped return envelops (88%) was higher than that of the franked return envelops (85%)(p = 0.27). The replies for the recorded and standard deliveries arrived an average of 10.2 and 9.9 business days, respectively, after the first mailing (p = 0.60). The average times of the responses for the stamped and franked return envelops were 9.8 and 10.4 business days, respectively (p = 0.25). Recorded deliveries significantly increased the response rate compared to standard deliveries, and stamped return envelops slightly increased the response rate a little compared to franked return envelops. The timing of response of recorded deliveries was similar to that of standard deliveries but the volume of response of recorded deliveries was higher than that of standard deliveries.

Data Collection↗
PubMed2000

Tricyclic antidepressants for depressive disorders in children and adolescents: a meta-analysis of randomized-controlled trials.

The tricyclic antidepressants (TCAs) are effective for the treatment of adult depression. However, their efficacy of these in the treatment of children and adolescents with depression is equivocal. Therefore, it is necessary to determine the efficacy and acceptability of TCAs in the treatment of depressive disorders in children and adolescents. The databases of MEDLINE (from 1966 to October 1999) and Controlled Clinical Trials Registered (from 1980 to October 1999) were searched for randomized-controlled trials relevant to the use of TCAs for treating depressed children and adolescents. The reviewers also examined the reference lists of identified papers and that of a previous meta-analysis. In each trial, both nonresponse rates and dropout rates were taken into account and extracted on an intention-to-treat basis. The nonresponse-rate and dropout-rate odd ratios (ORs) with 95 per cent confidence intervals (95% CIs) of each trial and the pooled non-response-rate and dropout-rate ORs (95% CIs) of all trials were computed. Nine trials included in this meta-analysis were 2 amitriptyline, 3 desipramine, 2 imipramine, and 2 nortriptyline studies. By using a fixed-effect model, the pooled nonresponse-rate OR (95% CI) and the pooled dropout rate OR (95% CI) of antidepressant-treated group were 0.92 (0.57 to 1.47) and 2.14 (1.12 to 4.09), respectively. In summary, the evidence so far does not support that TCAs are more effective or more acceptable than placebo in the treatment of depressive disorders in children and adolescents. However, the studies of selective serotonin reuptake inhibitors and newer antidepressants for the treatment of these disorders should be further investigated.

Adolescent↗
PubMed2026

Comparison of summative assessments between simulated electronic health records versus traditional paper-based patient cases: A non-inferiority randomized controlled trial.

INTRODUCTION: Electronic health records are fundamental to contemporary pharmacy practice, yet evidence supporting their use in pharmacy education is lacking. This single-center, non-inferiority randomized controlled trial with blinded outcome assessment evaluated whether delivering patient cases via a simulated academic EHR (aEHR) was non-inferior to a traditional paper-based format in student exam performance. METHODS: 53 third-year PharmD students at the University of British Columbia were randomized 1:1 to complete a mock summative examination using either the aEHR or paper-based case delivery, stratified by self-reported EHR comfort level. The primary outcome was mean written exam score (%). Non-inferiority was pre-specified at a margin of 14%. Adjusted linear regression was used for the primary analysis, with a multiple imputation sensitivity analysis. Student perceptions were explored through post-exam focus groups analyzed using inductive thematic analysis. RESULTS: 42 students (21 per group) completed the exam and were included in the primary analysis. Mean scores were 66% (SD 11) in the aEHR group and 68% (SD 10) in the paper group. The adjusted mean difference (paper minus aEHR) was -2.2% (95% CI -9.2% to +4.8%), satisfying non-inferiority but not superiority. Sensitivity analysis (n&#xa0;=&#xa0;53) yielded consistent results (-2.3%; 95% CI -7.1% to +4.1%). Focus groups revealed initial student anxiety with the aEHR but recognized its alignment with clinical practice. DISCUSSION: These findings support the feasibility of integrating simulated EHRs into summative pharmacy assessments without compromising performance. CONCLUSION: Simulated EHRs are a non-inferior assessment medium compared with paper-based formats and represent a viable step toward technology-driven pharmacy practice environments.

Humans↗
PubMed1978

A randomized controlled trial of a short course of cephaloridine in the prevention of infection after abdominal hysterectomy.

One hundred patients took part in a randomized controlled trial to test the efficacy of three 1 g doses of cephaloridine in preventing infection after abdominal hysterectomy. The first dose was given as an intravenous bolus at the commencement of surgery and the second and third as intramuscular injections 6 and 12 hours later. Given in this way, cephaloridine was found to be very effective in preventing febrile morbidity, abdominal wound infection and urinary tract infection. It was less effective in preventing pelvic wound infection and postoperative colonization of the vagina with Escherichia coli.

Cephaloridine↗
PubMed1997

Evaluation of index and profile measures of health status in a randomized controlled trial. Comparison of the Medical Outcomes Study 36-Item Short Form Health Survey, EuroQol, and disease specific measures.

OBJECTIVES: The authors compare two generic measures of health status with disease-specific measures in a randomized controlled trial of transurethral resection of the prostate with laser vaporization prostatectomy for benign prostatic hypertrophy. METHODS: Patients entered into the trial completed the following questionnaires prior to treatment and at follow-up at 3 months and 1 year. The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) is a generic measure that produces an eight-dimension profile as well as two summary measures of health status (the physical component score and the mental component score). The EuroQol provides two single index measures of health status; one intended to convey the utility (or lack of) that an individual derives from his or her own health state compared with alternative states and a second simple visual analog scale "thermometer" of health status. The American Urological Association symptom score and the Bothersome index are disease-specific indices of health status for use specifically with benign prostatic hypertrophy patients. RESULTS: The EuroQol indicates no statistically significant improvements with time for either arm of the trial. The SF-36 physical and general health perceptions domains indicates statistically significant improvements for the transurethral resection of the prostate arm alone at 3 months and 1 year, as do the physical summary score at the 3-month follow-up visit. The effect sizes of these improvements, however, are small, using standard criteria. In contrast, statistically significant differences are found with time for both transurethral resection of the prostate and laser prostatectomy on both disease-specific measures, which also indicate statistically significant superior outcome for the transurethral resection of the prostate arm compared with the laser arm. CONCLUSIONS: The results indicate that the disease-specific measures are more sensitive to change than the generic measures of outcome. Possible explanations for this are discussed.

Follow-Up Studies↗
PubMed2002

Acupuncture to treat nausea and vomiting in early pregnancy: a randomized controlled trial.

BACKGROUND: Nausea and vomiting in early pregnancy are troublesome symptoms for some women. We undertook a single blind randomized controlled trial to determine whether acupuncture reduced nausea, dry retching, and vomiting, and improved the health status of women in pregnancy. METHODS: The trial was undertaken at a maternity teaching hospital in Adelaide, Australia, where 593 women less than 14 weeks' pregnant with symptoms of nausea or vomiting were randomized into 4 groups: traditional acupuncture, pericardium 6 (p6) acupuncture, sham acupuncture, or no acupuncture (control). Treatment was administered weekly for 4 weeks. The primary outcomes were nausea, dry retching, vomiting, and health status. Comparisons were made between groups over 4 consecutive weeks. RESULTS: Women receiving traditional acupuncture reported less nausea (p < 0.01) throughout the trial and less dry retching (p < 0.01) from the second week compared with women in the no acupuncture control group. Women who received p6 acupuncture (p < 0.05) reported less nausea from the second week of the trial, and less dry retching (p < 0.001) from the third week compared with women in the no acupuncture control group. Women in the sham acupuncture group (p < 0.01) reported less nausea and dry retching (p < 0.001) from the third week compared with women in the no acupuncture group. No differences in vomiting were found among the groups at any time. CONCLUSION: Acupuncture is an effective treatment for women who experience nausea and dry retching in early pregnancy. A time-related placebo effect was found for some women.

Acupuncture Therapy↗
PubMed2002

Periodontal therapy may reduce the risk of preterm low birth weight in women with periodontal disease: a randomized controlled trial.

BACKGROUND: Recent studies have suggested that periodontal disease is a risk factor for preterm low birth weight (PLBW). A randomized controlled trial was undertaken to help further evaluate the proposed association between periodontal disease and PLBW. METHODS: Four hundred pregnant women with periodontal disease, aged 18 to 35, were enrolled while receiving prenatal care in Santiago, Chile. Women were randomly assigned to either an experimental group (n = 200), which received periodontal treatment before 28 weeks of gestation or to a control group (n = 200) which received periodontal treatment after delivery. Previous and current pregnancies and known risk factors were obtained from patient medical records and interviews. The primary outcome assessed was the delivery at less than 37 weeks of gestation or an infant weighing less than 2,500 g. RESULTS: Of the 400 women enrolled, 49 were excluded from the analyses for different reasons. The incidence of PLBW in the treatment group was 1.84% (3/163) and in the control group was 10.11% (19/188), (odds ratio [OR] 5.49, 95% confidence interval [CI] 1.65 to 18.22, P= 0.001). Multivariate logistic regression analysis showed that periodontal disease was the strongest factor related to PLBW (OR 4.70, 95% CI 1.29 to 17.13). Other factors significantly associated with such deliveries were: previous PLBW (OR 3.98, 95% CI 1.11 to 14.21), less than 6 prenatal visits (OR 3.70, 95% Cl 1.46 to 9.38), and maternal low weight gain (OR 3.42, 95% CI 1.16 to 10.03). CONCLUSIONS: Periodontal disease appears to be an independent risk factor for PLBW. Periodontal therapy significantly reduces the rates of PLBW in this population of women with periodontal disease.

Adolescent↗
PubMed2004

Women's views regarding participation in a proposed randomized controlled trial of twin delivery.

OBJECTIVE: To determine the views of women regarding participation in a proposed multicentre randomized controlled trial comparing planned vaginal birth to planned Caesarean delivery for twins at 32 or more weeks' gestation, in which the first twin (twin A) is presenting as a vertex. METHODS: Pregnant women with a known twin gestation were recruited from 2 hospital centres. Written information was provided about the proposed Twin Birth Study, and the women were then requested to complete a questionnaire to determine their views regarding participation in the proposed trial. RESULTS: Of the 64 women recruited for the study, 31 (48%) indicated they would be willing to consider participating in the proposed trial (95% CI, 37-60%), 14 (22%) were unsure about trial participation (95% CI, 13-33%), and 19 (30%) indicated they would not be willing to participate in the proposed study (95% CI, 20-42%). The most common reason for agreement to participation was altruism (n = 28). Those who responded "not sure" wished to speak with their partner (n = 5) or their doctor (n = 8) before deciding on participation. Of those who indicated they would not participate in the proposed trial, 12 (63%) indicated they preferred to have a vaginal birth, and 7 (37%) preferred to have a Caesarean section. CONCLUSIONS: Almost half the women in our sample were agreeable to considering their participation in a randomized trial that will compare planned vaginal birth to planned Caesarean section for twins at 32 or more weeks' gestation with twin A presenting as a vertex. Altruism was the most common reason for agreeing to participate, whereas preference for a specific mode of delivery was the most common reason for declining participation.

Adult↗
PubMed1996

Parental presence during induction of anesthesia. A randomized controlled trial.

BACKGROUND: To determine whether parental presence during induction of anesthesia is an effective preoperative behavioral intervention, a randomized controlled trial with children undergoing outpatient surgery was conducted. METHODS: Eighty-four children were randomly assigned to a parent-present or parent-absent group. Using multiple behavioral and physiologic measures of anxiety, the effect of the intervention on the children and their parents was assessed. Predictors for the response to the intervention were examined using multivariate linear regression analysis. RESULTS: When the intervention group (parent-present) was compared to the control group (parent-absent), overall there were no significant differences in any of the behavioral or physiologic measures of anxiety tested during induction of anesthesia. Using the child's serum cortisol concentration as the outcome, parental presence, the child's age and baseline temperament, and trait anxiety of the parent, were identified as predictors of the child's anxiety during induction. Analysis of variance demonstrated that three groups showed diminished cortisol concentrations with parental presence: children older than 4 yr (P = 0.001), children whose parent had a low trait anxiety (P = 0.02), and children who had a low baseline level of activity as assessed by temperament (P = 0.05). CONCLUSIONS: Children who were older than 4 yr or those with a parent with a low trait anxiety or who had a low baseline level of activity/temperament benefited from parental presence during induction.

Anesthesia↗