Prospective evaluation of complications of dorsal penile nerve block for neonatal circumcision

OBJECTIVE: To evaluate the complications of the dorsal penile nerve block (DPNB) when used for routine neonatal circumcisions. METHODS: All male newborns born in a community hospital between November 1, 1989 and August 31, 1990, and circumcised after DPNB were evaluated. Questionnaires were completed at the time of hospital discharge and at a health supervision visit 2 weeks later. RESULTS: Questionnaires were returned for 491 (85%) eligible patients. The only complication of DPNB found was bruising at the site of injection in 54 patients (11%). All bruising had resolved by the 2-week visit, and none was thought to have any clinical significance. CONCLUSION: DPNB is a safe method of decreasing the pain and stress of neonatal circumcision.     

Parents and procedures: a randomized controlled trial

INTRODUCTION: Previous work has shown that parents prefer to be present when their children undergo common invasive procedures, although physicians are ambivalent about parental presence. PURPOSE: To determine the effect of a parent-focused intervention on the pain and performance of the procedure, anxiety of parents and clinicians, and parental satisfaction with care. POPULATION: Children younger than 3 years old undergoing venipuncture, intravenous cannulation, or uretheral catheterization. SETTING: Pediatric emergency department of Boston City Hospital. DESIGN: Randomized controlled trial with three groups; parents present and given instructions on how to help their children; parents present, but no instructions given; and parents not present. INTERVENTION: The parents were instructed to touch, talk to, and maintain eye contact during the procedure. RESULTS: A total of 431 parents was randomized to the intervention (N = 153), present (N = 147), and not present (N = 131) groups. The groups were equivalent with respect to measured sociodemographic variables and parents' previous experience in the pediatric emergency department. No differences emerged with respect to pain (3-point scale measured by parent and clinician, and analysis of cry); performance of the procedure (number of attempts, completion of procedure by first clinician, time); clinician anxiety; or parental satisfaction with care. Parents who were present were more likely to rate the pain of the children as extreme/severe (52%) in comparison to clinicians (15%, kappa .07, poor agreement) and were significantly less anxious than parents who were not present. CONCLUSION: Overall, the intervention was not effective in reducing the pain of routine procedures. Parental presence did not negatively affect performance of the procedure or increase clinician anxiety. Parents who were present were less anxious than those who were not present. CLINICAL IMPLICATION: In general, parents have indicated that they want to be present when their children undergo procedures. The results of this study challenge the traditional belief that parental presence negatively affects our ability to successfully complete procedures. We should encourage parents who want to be present to stay during procedures.     

Comparison of flutamide and spironolactone in the treatment of hirsutism: a randomized controlled trial

OBJECTIVE: To compare the clinical efficacy and safety of the pure antiandrogen flutamide and the steroidal derivative spironolactone in the treatment of hirsutism in women. DESIGN: Fifty-three premenopausal women suffering from moderate to severe hirsutism were randomized into two groups and received either flutamide or spironolactone in association with a triphasic oral contraceptive (OC) pill. Hirsutism, acne, seborrhea, alopecia, and side effects were monitored monthly for a treatment period of 9 months and a follow-up after treatment period of 6 months. Blood samples were taken at each visit for assessment of endocrine, biochemical, and hematologic parameters. RESULTS: After only 6 months of therapy, flutamide caused a maximal reduction in the hirsutism score to a value within almost normal range; during the same period, spironolactone caused only a 30% reduction of the hirsutism score. Whereas flutamide caused a dramatic (80%) decrease in total acne, seborrhea, and hair loss score after only 3 months of therapy, spironolactone caused only a 50% reduction in acne and seborrhea, with no significant effect on the hair loss score. Four patients in the spironolactone group but only one in the flutamide group stopped the medication because of adverse side effects. CONCLUSION: The present data obtained in a randomized prospective study clearly demonstrate that the pure antiandrogen flutamide is superior to spironolactone in the treatment of female hirsutism and its related androgen-dependent symptoms and signs in women.     

Moxibustion for correction of breech presentation: a randomized controlled trial

CONTEXT: Traditional Chinese medicine uses moxibustion (burning herbs to stimulate acupuncture points) of acupoint BL 67 (Zhiyin, located beside the outer corner of the fifth toenail), to promote version of fetuses in breech presentation. Its effect may be through increasing fetal activity. However, no randomized controlled trial has evaluated the efficacy of this therapy. OBJECTIVE: To evaluate the efficacy and safety of moxibustion on acupoint BL 67 to increase fetal activity and correct breech presentation. DESIGN: Randomized, controlled, open clinical trial. SETTING: Outpatient departments of the Women's Hospital of Jiangxi Province, Nanchang, and Jiujiang Women's and Children's Hospital in the People's Republic of China. PATIENTS: Primigravidas in the 33rd week of gestation with normal pregnancy and an ultrasound diagnosis of breech presentation. INTERVENTIONS: The 130 subjects randomized to the intervention group received stimulation of acupoint BL 67 by moxa (Japanese term for Artemisia vulgaris) rolls for 7 days, with treatment for an additional 7 days if the fetus persisted in the breech presentation. The 130 subjects randomized to the control group received routine care but no interventions for breech presentation. Subjects with persistent breech presentation after 2 weeks of treatment could undergo external cephalic version anytime between 35 weeks' gestation and delivery. MAIN OUTCOME MEASURES: Fetal movements counted by the mother during 1 hour each day for 1 week; number of cephalic presentations during the 35th week and at delivery. RESULTS: The intervention group experienced a mean of 48.45 fetal movements vs 35.35 in the control group (P<.001; 95% confidence interval [CI] for difference, 10.56-15.60). During the 35th week of gestation, 98 (75.4%) of 130 fetuses in the intervention group were cephalic vs 62 (47.7%) of 130 fetuses in the control group (P<.001; relative risk [RR], 1.58; 95% CI, 1.29-1.94). Despite the fact that 24 subjects in the control group and 1 subject in the intervention group underwent external cephalic version, 98 (75.4%) of the 130 fetuses in the intervention group were cephalic at birth vs 81 (62.3%) of the 130 fetuses in the control group (P = .02; RR, 1.21; 95% CI, 1.02-1.43). CONCLUSION: Among primigravidas with breech presentation during the 33rd week of gestation, moxibustion for 1 to 2 weeks increased fetal activity during the treatment period and cephalic presentation after the treatment period and at delivery.     

Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial

CONTEXT: Postherpetic neuralgia (PHN) is a syndrome of often intractable neuropathic pain following herpes zoster (shingles) that eludes effective treatment in many patients. OBJECTIVE: To determine the efficacy and safety of the anticonvulsant drug gabapentin in reducing PHN pain. DESIGN: Multicenter, randomized, double-blind, placebo-controlled, parallel design, 8-week trial conducted from August 1996 through July 1997. SETTING: Sixteen US outpatient clinical centers. PARTICIPANTS: A total of 229 subjects were randomized. INTERVENTION: A 4-week titration period to a maximum dosage of 3600 mg/d of gabapentin or matching placebo. Treatment was maintained for another 4 weeks at the maximum tolerated dose. Concomitant tricyclic antidepressants and/or narcotics were continued if therapy was stabilized prior to study entry and remained constant throughout the study. MAIN OUTCOME MEASURES: The primary efficacy measure was change in the average daily pain score based on an 11-point Likert scale (0, no pain; 10, worst possible pain) from baseline week to the final week of therapy. Secondary measures included average daily sleep scores, Short-Form McGill Pain Questionnaire (SF-MPQ), Subject Global Impression of Change and investigator-rated Clinical Global Impression of Change, Short Form-36 (SF-36) Quality of Life Questionnaire, and Profile of Mood States (POMS). Safety measures included the frequency and severity of adverse events. RESULTS: One hundred thirteen patients received gabapentin, and 89 (78.8%) completed the study; 116 received placebo, and 95 (81.9%) completed the study. By intent-to-treat analysis, subjects receiving gabapentin had a statistically significant reduction in average daily pain score from 6.3 to 4.2 points compared with a change from 6.5 to 6.0 points in subjects randomized to receive placebo (P<.001). Secondary measures of pain as well as changes in pain and sleep interference showed improvement with gabapentin (P<.001). Many measures within the SF-36 and POMS also significantly favored gabapentin (P< or =.01). Somnolence, dizziness, ataxia, peripheral edema, and infection were all more frequent in the gabapentin group, but withdrawals were comparable in the 2 groups (15 [13.3%] in the gabapentin group vs 11 [9.5%] in the placebo group). CONCLUSIONS: Gabapentin is effective in the treatment of pain and sleep interference associated with PHN. Mood and quality of life also improve with gabapentin therapy.     

Outcome of subacute stroke rehabilitation: a randomized controlled trial

We compared the biological activity of a new group of keto-C-glycosides to that of a narrow spectrum of unsaturated ketonucleosides in a panel of non-small-cell lung cancer (NSCLC) cells with various levels of intrinsic resistance to standard chemotherapy drugs. Unlike cisplatin, etoposide, adriamycin, or taxol, for which a significant difference in the cytotoxic effect was observed between sensitive cell lines (H460, H125, and MGH4) and drug-resistant cell lines (H661, MGH7, and FADU), nucleoside analogs were equally cytotoxic in NSCLC cell lines, with compound 92 being 10-fold more active than compound 43, 44, 81, or 161, while compound 3 was the least active. Apoptotic measurements with flow cytometric analysis of terminal uridine deoxynucleotide nick end-labeled cells revealed that the cytotoxic activity of these nucleosides correlated with their potency to induce apoptosis. Compound 92 triggered death in cells with wild-type p53, mutated p53, or p53 gene deletion. Our findings suggest that keto-C-glycosides may be promising alternative anticancer agents which merit further studies in in vivo cancer models refractory to standard chemotherapy drugs.     

Rare complication of circumcision: penile amputation and reattachment

We report a case of traumatic penile amputation which occurred accidentally during a ritual circumcision in a 10-year-old boy. A successful penile reattachment was accomplished. Additionally, we discussed the causes and prevention of this condition.     

Nebulized budesonide and oral dexamethasone for treatment of croup: a randomized controlled trial

CONTEXT: The effectiveness of glucocorticoids for patients with croup is well established but it remains uncertain which glucocorticoid regimen is most effective. OBJECTIVE: To determine the effectiveness of 3 glucocorticoid regimens in patients with croup. DESIGN: Randomized controlled trial with parallel design. SETTING: Emergency departments of 2 Canadian pediatric tertiary care hospitals. PARTICIPANTS: Children with a clinical syndrome consistent with croup, aged 3 months to 5 years, with a croup score of 2 or greater following at least 15 minutes of mist therapy. INTERVENTIONS: Oral dexamethasone, 0.6 mg/kg, and nebulized placebo; oral placebo and nebulized budesonide, 2 mg; or oral dexamethasone, 0.6 mg/kg, and nebulized budesonide, 2 mg. MAIN OUTCOME MEASURES: Westley croup score (primary outcome), hospital admission rates, time spent in the emergency department, return visits to the emergency department, or ongoing symptoms at 1 week. RESULTS: The mean change in the croup score from baseline to the final study assessment was -2.3 (95% confidence interval [CI], -2.6 to -2.0) in the budesonide group (n = 65), -2.4 (95% CI, -2.6 to -2.2) in the dexamethasone group (n = 69), and -2.4 (95% CI, -2.7 to -2.1) in the budesonide and dexamethasone group (n = 64, P = .70). CONCLUSIONS: Based on the similar outcomes in the 3 groups, oral dexamethasone is the preferred intervention because of its ease of administration, lower cost, and more widespread availability.     

Preventing sleep problems in infants: a randomized controlled trial

In the pre-school years sleep problems are one of the most common subjects on which parents seek advice from health professionals. In the majority of cases a sleepless child causes significant stress within the family, and if parents do not obtain sufficient sleep this can have a detrimental effect on their physical and emotional well-being. In a small number of cases a child who wakes frequently and will not settle back to sleep may be at risk of physical abuse. In recent years it has been suggested that it may be possible to prevent sleep problems developing by providing parents with advice in the post-natal period. Parents have stated that they find this type of intervention helpful, however, there has been no attempt to establish whether a preventive approach is effective. The aim of this research was to evaluate the efficacy of health education in reducing the incidence of sleep problems. Adopting an experimental approach, participants were randomly allocated to a control group or an intervention group. Parental knowledge of sleep and settling behaviour was manipulated when the children in the intervention group were 3 months old. The sleeping behaviour of the infants in both groups was compared 6 months later, when the children were 9 months old. Data was collected from 86 families in the intervention group and 83 families in the control group. A comprehensive analysis of the sleeping behaviour demonstrated that a significantly smaller percentage of babies in the intervention group had settling and night-waking difficulties than in the control group.     

A randomized, controlled trial of oral and intramuscular dexamethasone in the prevention of neonatal respiratory distress syndrome

OBJECTIVE: The study's objective was to compare the efficacies of oral and intramuscular antenatal administration of dexamethasone in reducing neonatal respiratory distress syndrome. STUDY DESIGN: Subjects at high risk for preterm delivery between 24 and 33 weeks' gestation were prospectively randomly assigned to receive either 6 mg intramuscular dexamethasone or 8 mg oral dexamethasone every 12 hours for 4 doses. The regimen was repeated weekly until 34 weeks' gestation if delivery had not yet occurred. A blinded data review was performed. The primary outcome of the trial was respiratory distress syndrome. Data were analyzed in an intent to treat fashion. Comparisons were made with an unpaired t test, chi2 or Fisher exact test, and survival analysis. P <.05 was considered significant. RESULTS: The study was discontinued at 39% enrollment after a blinded review of available outcomes. A total of 170 women with 188 fetuses were randomly assigned. The oral and intramuscular groups had similar mean gestational ages at enrollment (29.9 weeks vs 29.2 weeks) and similar median latencies (9.5 vs 10 days). No difference in the frequency of respiratory distress syndrome was found between the oral and intramuscular groups, (34.3% vs 29.8%). Neonatal sepsis (10.1% vs 1.2%, P =.01) and intraventricular hemorrhage (10.1% vs 2. 4%, P =.04) were significantly higher in the oral group. There were no statistical differences in the frequencies of necrotizing enterocolitis or neonatal death. A subgroup analysis of 112 patients who were delivered at <34 weeks' gestation revealed no statistical difference in respiratory distress syndrome between the groups; however, oral dexamethasone was associated with a significant increase in sepsis (15.9% vs 1.6%, P =.009) and intraventricular hemorrhage (15.9% vs 3.3%, P =.03). CONCLUSION: Oral administration increases neonatal morbidity without demonstrable benefit and should not at this time be used clinically for induction of fetal pulmonary maturation.     

Biofeedback-based behavioral treatment for chronic tinnitus: Results of a randomized controlled trial.

Many tinnitus sufferers believe that their tinnitus has an organic basis and thus seek medical rather than psychological treatments. Tinnitus has been found to be associated with negative appraisal, dysfunctional attention shift, and heightened psychophysiological arousal, so cognitive-behavioral interventions and biofeedback are commonly suggested as treatments. This study developed and investigated the efficacy of a biofeedback-based cognitive-behavioral treatment for tinnitus. In total, 130 tinnitus patients were randomly assigned to an intervention or a wait-list control group. Treatment consisted of 12 sessions of a biofeedback-based behavioral intervention over a 3-month period. Patients in the wait-list group participated in the treatment after the intervention group had completed the treatment. Results showed clear improvements regarding tinnitus annoyance, diary ratings of loudness, and feelings of controllability. Furthermore, changes in coping cognitions as well as changes in depressive symptoms were found. Improvements were maintained over a 6-month follow-up period in which medium-to-large effect sizes were observed. The treatment developed and investigated in this study is well accepted and leads to clear and stable improvements. Through demonstration of psychophysiological interrelationships, the treatment enables patients to change their somatic illness perceptions to a more psychosomatic point of view. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Octreotide: effective treatment for hyperparathyroidism? A prospective, randomized, controlled clinical trial

Although clinical and electrophysiological evidence indicates that the amygdaloid body plays an important role in the pathogenesis of temporal lobe epilepsy, there are very few detailed data on histopathological changes in this nucleus in epilepsy patients. In the present study we have examined the lateral nucleus of the amygdaloid body in 70 surgical specimens from patients with temporal lobe epilepsy and in 10 control specimens with respect to neuronal density and gliosis. The results were compared to the neuronal loss in the hippocampal formation. Our goal was to examine the pathological alterations of the amygdaloid body and their correlation with other morphological changes in temporal lobe epilepsy. In epilepsy patients with Ammon's horn sclerosis or focal lesions of the temporal lobe, the neuronal density of the lateral amygdaloid nucleus was significantly decreased as compared to normal controls (P < 0.001). Overall, the mean volumetric density in epilepsy patients was reduced to 59% of that in normal individuals. There was no correlation between the neuronal density in the lateral amygdaloid nucleus and that in the different segments of the hippocampal formation or to the age at onset or the duration of epilepsy. The neuronal loss of the amygdaloid nucleus correlated well with the presence of fibrillary gliosis. Our findings demonstrate that the amygdaloid body is severely altered in most patients with temporal lobe epilepsy and that these changes are independent of those in the hippocampus. The presence of neuronal loss and gliosis in the amygdaloid nucleus of patients with focal lesions but no Ammon's horn sclerosis is compatible with an involvement of the amygdala in secondary epileptogenesis.     

Efficacy of octreotide in diarrhoea due to Vibrio cholerae: a randomized, controlled trial

The ultrastructure of autonomic nerve fibers and terminal varicosities is described in relation to the lamina propria of the human seminiferous tubules during childhood (age 3 to 10 years). Autonomic nerve varicosities are classified as: Type I with numerous small (30-60 nm) agranular vesicles and variable numbers of large (100 nm) granular vesicles, and Type II with numerous small (30-60 nm) granular vesicles and sporadic large granular vesicles. These two varicosity types are consistent in morphology with cholinergic and adrenergic nerve terminals, respectively. Nerve varicosities are found, associated with Schwann cells, in proximity to the cells of the lamina propria. Although not found in direct "synaptic' contact, these autonomic endings are often within a few hundred nanometers of the cellularity of the lamina propria. The Schwannian sheath is interrupted over the varicosities at these sites and occasionally the terminal varicosities are totally lacking a Schwann sheath. These findings are consistent with the structural relationship of autonomic nerve "terminals' and effector in other endocrine and non-endocrine systems. This is the first evidence of adrenergic nerve varicosities in proximity to the lamina propria in humans (at any age). Evidence is also presented which suggests a locational difference in the distribution of cholinergic (Type I) and adrenergic (Type II) nerve varicosities in this region, with only cholinergic endings observed directly adjacent to the basal lamina of the seminiferous tubules.     

Therapeutic efficacy of tirilazad in experimental multiple cerebral emboli: a randomized, controlled trial

OBJECTIVE: A significant proportion of patients who undergo cardiac surgery or carotid endarterectomy appear to develop subtle cognitive deficits, with the occurrence of multiple cerebral microemboli documented by Doppler ultrasound during these procedures. We used an experimental multiple cerebral embolism model to test whether treatment with tirilazad (U74006F), a putative inhibitor of lipid peroxidation, would improve functional outcome after multiple brain emboli. DESIGN: Randomized, controlled trial. SETTING: Animal care facility procedure room. SUBJECTS: A total of 44 New Zealand White rabbits weighing 2 to 3.0 kg. INTERVENTIONS: Variable quantities of 125I-labeled 50-microns microspheres were injected via a carotid catheter to produce multifocal brain ischemia. Rabbits randomly received either: tirilazad (3 mg/kg i.v.) 5 mins before embolization (pretreatment), or 30 mins after embolization (posttreatment) followed by 1.5 mg/kg every 5 hrs x 3 doses. A third group received vehicle only (control) 5 mins before, followed by three doses every 5 hrs. MEASUREMENTS AND MAIN RESULTS: The animals were rated by a blinded observer at 18 hrs after ischemia and scored as either grossly abnormal/dead or normal. The animals were killed and the amount of microspheres in the brain that were required to produce abnormal function at 18 hrs was calculated for each group. To determine if tirilazad also modified leukocyte function during ischemia, neutrophil adhesion to laminin was determined at baseline and 18 hrs after ischemia using a myeloperoxidase assay. In this study, pretreatment, but not posttreatment with tirilazad produced a significant reduction in neurologic deficits. Tirilazad also attenuated postischemic increases in neutrophil adhesion. CONCLUSIONS: Tirilazad pretreatment reduces neurologic deficits from multiple cerebral emboli. This significant protective effect suggests that pretreatment with tirilazad may play a role in clinical situations where the risk of cerebral emboli is high, with changes in leukocyte adherence as a potential mechanism.     

Prospective randomized controlled trial of preservation of the intercostobrachial nerve during axillary node clearance for breast cancer

OBJECTIVE: The authors' goal was to determine whether cognitive behavioral treatment of residual symptoms of depression might have a significant effect on relapse rate. METHOD: A 6-year follow-up assessment was conducted of 40 patients with primary major depressive disorder who had been successfully treated with antidepressants and were randomly assigned to either cognitive behavioral treatment of residual symptoms or standard clinical management. RESULTS: Ten of the patients (50%) in the cognitive behavioral treatment group and 15 (75%) in the standard clinical management group relapsed. The difference did not attain statistical significance. When multiple relapses were considered, patients in the cognitive behavioral treatment group had a significantly lower number of depressive episodes than those in the standard clinical management group. Patients responded to the same antidepressant drug used in the index episode; in two cases (4%), resistance occurred. CONCLUSIONS: The protective effects of cognitive behavioral treatment that were evident at 4-year follow-up faded afterward. Cognitive behavioral treatment of residual symptoms, however, improved the long-term outcome of major depression in terms of total number of episodes during the follow-up period.     

Patient-controlled sedation and analgesia, using propofol and alfentanil, during colonoscopy: a prospective randomized controlled trial

BACKGROUND AND STUDY AIMS: Patient-controlled sedation (PCS) enables titration of dosage to an individual's requirements and is potentially useful in colonoscopy. The aim was to compare the value of patient-controlled sedation, using propofol and alfentanil, with that of intravenous diazemuls and pethidine during colonoscopy. PATIENTS AND METHODS: Following randomization, 66 patients undergoing colonoscopy received either an intravenous bolus of pethidine (50 mg) and diazemuls (10-20 mg) prior to colonoscopy or were connected to an infusion pump containing propofol (10 mg/ml) and alfentanil (25 microg/ml). Patients self-administered 0.5 ml boluses as often as they required. Pain and sedation score were recorded by a nurse specialist and on a patient questionnaire. An anaesthetist was present throughout the procedure. RESULTS: PCS provided lighter sedation (median sedation score, 3 versus 4; P=0.0001), less analgesia (median pain score, 1 versus 0; P=0.004), a smaller maximum fall in systolic blood pressure (23 mmHg versus 33 mmHg; P=0.02) and a faster recovery time (median 10 min versus 40 min; P=0.0001), irrespective of the dose administered, compared with a diazemuls-pethidine combination. The duration of the procedure was unaffected. All patients were satisfied with their level of sedation. CONCLUSIONS: Patient-controlled sedation is an effective alternative to premedication with narcotic/benzodiazepine combinations during colonoscopy.