Letter to the Editor

PEDIATRICS ◽  
1994 ◽  
Vol 93 (5) ◽  
pp. 871-871
Author(s):  
Mary C. Theroux ◽  
David West
Keyword(s):  
Heart Rate ◽  
Placebo Group ◽  
Multiple Comparisons ◽  
Control Group ◽  
Placebo Control ◽  
Maximum Heart Rate ◽  
Control Groups ◽  
Placebo Control Group ◽  
Objective Outcome ◽  
Mean Heart Rate

We thank Drs Lopez and Urbansky for their comments. Their observation that the placebo group may have sufficiently biased the combined placebo/control group to account for the significant findings noted is reasonable, despite no significant differences being found between the placebo group and the control group. Analysis of variance among the three groups was carried out for the objective outcome variables. Differences in mean heart rate changes and maximum heart rate changes remained significant, and differences between study versus control groups and study versus placebo groups were both found to be significant, accounting for multiple comparisons.

Efficacy of Intranasal Midazolam in Facilitating Suturing of Lacerations in Preschool Children in the Emergency Department

PEDIATRICS ◽  
1993 ◽  
Vol 91 (3) ◽  
pp. 624-627
Author(s):  
Mary C. Theroux ◽  
David W. West ◽  
David H. Corddry ◽  
Patrice M. Hyde ◽  
Steven J. Bachrach ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Emergency Department ◽  
Heart Rate ◽  
Placebo Group ◽  
Preschool Children ◽  
Control Group ◽  
Placebo Control ◽  
Midazolam Group ◽  
Placebo Control Group ◽  
Intranasal Midazolam

Sedating children safely and effectively for minor laceration repair is a well-recognized clinical problem. A randomized, double-blind, and controlled study was conducted to evaluate the efficacy of intranasal midazolam for reducing stress during the suturing of lacerations in preschool children. Fifty-nine children with simple lacerations that required suturing were randomly assigned to one of three groups. Group 1 received intranasal midazolam, 0.4 mg/kg, prior to suturing. Group 2 received an equivalent volume of normal saline intranasally prior to suturing as a placebo. Group 3 was the control group and received no intervention prior to suturing. Heart rate, respiratory rate, blood pressure, and pulse oximetry were monitored at 5-minute intervals throughout the procedure. Subjective variables were also measured at 5-minute intervals and included a cry score, a motion score, and a struggle score. Parent satisfaction was measured via a short telephone interview the following day. There were no significant differences in outcome between the placebo group and the control group. Their results were pooled and compared with the results for the midazolam group. The midazolam group showed significant reductions for mean heart rate, maximum heart rate, and maximum systolic blood pressure when compared with the placebo/control group. Scores for two of the three subjective variables, cry and struggle, were significantly reduced for the midazolam group. The papoose board was considered unnecessary in retrospect for more than half of patients in the midazolam group compared with only one fifth of patients in the placebo/control group. Telephone follow-up revealed that parents in the midazolam group were twice as likely (68% vs 33%) to find the suture experience in the emergency department better than they had expected. No respiratory depression or any other significant adverse effects were noted in any of the three groups. It is concluded that infranasal midazolam was effective and safe in reducing anxiety and stress, which commonly accompany the suturing of lacerations in healthy preschool children.

scholarly journals Efficacy of a novel topical combination of esafoxolaner, eprinomectin and praziquantel against Echinococcus multilocularis infections in cats

Parasite ◽  
2021 ◽  
Vol 28 ◽  
pp. 29
Author(s):  
Joe Prullage ◽  
Dwight Bowman ◽  
Michael Ulrich ◽  
Eric Tielemans
Keyword(s):  
Echinococcus Multilocularis ◽  
Experimental Studies ◽  
The United States ◽  
Treated Group ◽  
Control Group ◽  
Placebo Control ◽  
The Novel ◽  
Control Groups ◽  
Geometric Means ◽  
Placebo Control Group

NexGard® Combo, a novel topical endectoparasiticide formulation for cats combining esafoxolaner, eprinomectin and praziquantel, for the treatment of internal and external parasite infestations, including arthropods, nematodes and cestodes, was tested for efficacy against induced infections of Echinococcus multilocularis in cats, in two experimental studies. The two studies were performed in the United States with the same E. multilocularis isolate sourced locally. In each study, 20 cats were inoculated intra-gastrically with ~30,000 E. multilocularis protoscoleces three weeks before treatment, then ten cats were randomly allocated to a placebo control group or to the novel formulation treated group. Inoculated cats were treated topically once at the minimum recommended dose of the novel formulation, or with an identical volume of placebo. One week after treatment, cats were humanely euthanized for parasite recovery and count. The efficacy calculation was based on comparison of number of scoleces found in the control group and the novel formulation group. In the two control groups, E. multilocularis scoleces were found in five (range: 30–1025) and eight (range 2–345) cats, the geometric means inclusive of the ten cats per group were 8.9 and 28.8, respectively. In the two novel formulation-treated groups, none of the cats harbored any E. multilocularis scoleces, demonstrating 100% efficacy.

scholarly journals Comparative effects of lidocaine and esmolol in attenuating the hemodynamic response to laryngoscopy and intubation

2017 ◽  
Vol 17 (2) ◽  
pp. 23-30
Author(s):  
Ram Bhakta Koju ◽  
Y Dongol
Keyword(s):  
Blood Pressure ◽  
Placebo Group ◽  
Statistical Significance ◽  
Hemodynamic Response ◽  
Hemodynamic Instability ◽  
Control Group ◽  
Placebo Control ◽  
Lidocaine Group ◽  
Placebo Control Group ◽  
American Society

Introduction: Transient hemodynamic instability is an inevitable outcome of laryngoscopy and intubation which can have serious effects in patients with COPD, heart disease and hypertension. Hemodynamic stability is one of the main goals of the anesthesiologist. This study was performed to compare the safety and effectiveness of lidocaine and esmolol in comparison to placebo-control group, in modifying the hemodynamic response to laryngoscopy and intubation.Methods: After approval of the study protocol by the institutional review board (IRB), written informed consent was obtained from each patient. It was a randomized placebo-controlled, double-blinded study. 75 patients of American Society of Anesthesiologists physical status I and II, scheduled for general surgery under GA, aged between 20-60 years were randomly allocated into three groups: placebo control group (n=25), lidocaine group (n=25) and esmolol group (n=25). Placebo group received 12 ml normal saline, lidocaine group received 1.5mg/kg lidocaine (total volume 12 ml) and esmolol group received 1.4mg/kg esmolol (total volume 12ml).Results: Following laryngoscopy and intubation, the increase in systolic blood pressure, diastolic blood pressure and heart rate were significantly lower (p < 0.05) in esmolol group compared to the lidocaine and placebo group but there was no statistical significance (p > 0.05) between control and lidocaine group.Conclusion: Esmolol 1.4 mg/kg IV was significantly more effective in controlling the hemodynamic response following laryngoscopy and intubation in comparison to lidocaine 1.5 mg/kg.Journal of Society of Surgeons of NepalVol. 17, No. 2, 2014, Page: 23-30

ESTIMATING EFFECTS OF SYSTEMATIC TREATMENT ON RENAL FAILURE AND DEATH WITHOUT A PARALLEL PLACEBO CONTROL GROUP

Nephrology ◽  
2000 ◽  
Vol 5 (3) ◽  
pp. A97-A97
Author(s):  
Hoy We ◽  
Baker P ◽  
Wang Z ◽  
Cass A ◽  
Mathews Jd ◽  
...  
Keyword(s):  
Renal Failure ◽  
Control Group ◽  
Placebo Control ◽  
Systematic Treatment ◽  
Placebo Control Group

Effect of the Modified Surgeon Assisted Bilateral Transversus Abdominis Plane Block on Time Required for First Analgesic Dose after Cesarean Section under Spinal Anesthesia: Randomized placebo-control

2021 ◽  
Vol 4 (3) ◽  
pp. 01-05
Author(s):  
Ahmed Mamdouh
Keyword(s):  
Placebo Group ◽  
Cesarean Section ◽  
Spinal Anesthesia ◽  
Interquartile Range ◽  
Transversus Abdominis ◽  
Secondary Outcome ◽  
Control Group ◽  
Placebo Control ◽  
Study Group ◽  
Tap Block

Background: The transverses abdominis plane block (TAP block) is one of the widely used regional analgesic techniques in cesarean section. There are different variations of the procedure. The aim of the present study was to evaluate the analgesic effect of the modified surgeon assisted bilateral TAP block in patients undergoing cesarean section Patients&Methods: Sixty patients undergoing cesarean section under spinal anesthesia were randomized into two groups to receive either TAP block with 40 ml of bupivacaine 0.25%(study group) or 40 ml normal saline as placebo after obtaining informed consent. All patients will receive intravenous diclofencac75mg every 12 hrs postoperatively. Postoperatively, there was an assessment every 2hrs during the first 24hrs by the visual analogue pain scale (VAPS). Time to the first analgesic request will be measured as primary outcome and all patients will receive opioid on demand or VAPS > 4 with 25mg pethidine intramuscularly. Moreover, total opioid requirement in 24hrs will be measured as secondary outcome along with postoperative complications as nausea, vomiting and abdominal distention. Complications related to the TAP procedure will be also assessed. Results: The median (interquartile range) time to the first analgesic request in the first 24hrs postoperatively was significantly shorter in the placebo group compared to the study group; 4h (4, 6) and 24h (10, 24) with p value < 0.001. Postoperative opioid requirement was significantly higher in the control group (30/30{100%}) than the study group (13/30{43.3%}). The median (interquartile range) number of opioid doses was significantly higher in the placebo group compared with the study group; 2(2, 2) and 0(0, 1) respectively. At all points in the study, pain scores both were lower in the study group (p < 0.0001). Conclusion: The modified surgeon assisted bilateral TAP block is relatively new, safe and cost effective technique which provides adequate postoperative analgesia allowing for better maternal ambulation and better postoperative recovery. Trial registration: Clinicaltrial.gov registration number: NCT04623632

scholarly journals Efficacy and Safety of Ejiao (Asini Corii Colla) in Women With Blood Deficient Symptoms: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Li Zhang ◽  
Zhongju Xu ◽  
Tao Jiang ◽  
Jialu Zhang ◽  
Pinxian Huang ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Blood Cell ◽  
Control Group ◽  
Placebo Control ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Placebo Control Group ◽  
Sf 36

Equus asinus L [Equidae; Asini Corii Colla] (donkey-hide gelatin, Ejiao), a well-known traditional Chinese medicine, has been widely used to nourish the blood, especially for women. The aim of this study was to assess the efficacy and safety of Ejiao in blood-deficient patients. A total of 210 participants were recruited and randomly allocated into the placebo control group and Ejiao-treated group (6 g/day). The primary outcomes on the efficacy of Ejiao included traditional Chinese medicine symptom scores, blood indicators, and SF-36. The secondary outcomes were changes in fireness and safety evaluation. Results showed that Ejiao treatment for 8 weeks had significantly improved dizziness symptoms. Among the tested 24 blood biochemical parameters, the hematocrit and red blood cell numbers decreased in the placebo control group, but decreased significantly less in the Ejiao treatment group. The white blood cell and neutrophil counts increased in the Ejiao group but were within the normal range. In addition, the quality of life improved as the scores in SF-36 domains were significantly higher in the Ejiao group. At the same time, there was no significant change in the fire–heat symptoms score or other safety parameters. Considering all these, our study showed that Ejiao has a promising effect in women suffering from blood deficiency without obvious adverse effects.

Sulfinpyrazone And Prevention Of Postoperative Deep Venous Thrombosis(DVT)

1981 ◽  
Author(s):  
G Arapakis ◽  
A Trovas ◽  
G Orphanoudakis ◽  
P Vassilikos
Keyword(s):  
Arterial Thrombosis ◽  
Statistical Significance ◽  
Group Analysis ◽  
Control Group ◽  
Placebo Control ◽  
Double Blind Trial ◽  
Double Blind ◽  
Placebo Control Group ◽  
Postoperative Deep Venous Thrombosis ◽  
Surgical Operations

Though the antithrombotic properties of sulfinpyrazone (SP) in arterial thrombosis have been documented, its value in phlebothrombosis remains uncertain. In this randomized double-blind trial, the effect of SP (500mg I.M. twice daily for the first 10 postoperative days) on postoperative DVT was compared with a placebo control group. 96 (65 male and 31 female) patients 41 to 83 years of age undergoing major surgical operations were included in the trial. The composition of the two groups (treated and placebo) were homogenious regarding age, sex and type of operation (0,30<p<0,50). The incidence of DVT was estimated clinically and isotopically by the 125I-labelled figrinogen test.No clinical phlebothrombosis was observed in either group but DVT was detected isotopically in 4 (8,3%) out of 48 in the placebo and in 7 (14,5%) of the 48 in the SP group. Analysis by the x2 showed no statistical significance in the prevalence of postoperative DVT between the two groups (x2<x20,30/1). These results suggest that SP has no place in the prevention of postoperative DVT.

scholarly journals Improving mental health and physiological stress responses in mothers following traumatic childbirth and in their infants: study protocol for the Swiss TrAumatic biRth Trial (START)

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032469 ◽  
Author(s):  
Vania Sandoz ◽  
Camille Deforges ◽  
Suzannah Stuijfzand ◽  
Manuella Epiney ◽  
Yvan Vial ◽  
...  
Keyword(s):  
Infant Development ◽  
Primary Outcome ◽  
Physiological Stress ◽  
Control Group ◽  
Placebo Control ◽  
Ptsd Symptoms ◽  
Intrusive Memories ◽  
Placebo Control Group ◽  
Psychological Vulnerability ◽  
Traumatic Childbirth

IntroductionEmergency caesarean section (ECS) qualifies as a psychological trauma, which may result in postnatal post-traumatic stress disorder (PTSD). Maternal PTSD may not only have a significant negative impact on mother–infant interactions, but also on long-term infant development. The partner’s mental health may also affect infant development. Evidence-based early interventions to prevent the development of postpartum PTSD in mothers are lacking. Immediately after a traumatic event, memory formation is vulnerable to interference. There is accumulating evidence that a brief behavioural intervention including a visuospatial task may result in a reduction in intrusive memories of the trauma.Methods and analysisThis study protocol describes a double-blind multicentre randomised controlled phase III trial testing an early brief maternal intervention including the computer game ‘Tetris’ on intrusive memories of the ECS trauma (≤1 week) and PTSD symptoms (6 weeks, primary outcome) of 144 women following an ECS. The intervention group will carry out a brief behavioural procedure including playing Tetris. The attention-placebo control group will complete a brief written activity log. Both simple cognitive tasks will be completed within the first 6 hours following traumatic childbirth. The intervention is delivered by midwives/nurses in the maternity unit.The primary outcome will be differences in the presence and severity of maternal PTSD symptoms between the intervention and the attention-placebo control group at 6 weeks post partum. Secondary outcomes will be physiological stress and psychological vulnerability, mother–infant interaction and infant developmental outcomes. Other outcomes will be psychological vulnerability and physiological regulation of the partner and their bonding with the infant, as well as the number of intrusive memories of the event.Ethics and disseminationEthical approval was granted by the Human Research Ethics Committee of the Canton de Vaud (study number 2017–02142). Dissemination of results will occur via national and international conferences, in peer-reviewed journals, public conferences and social media.Trial registration numberNCT 03576586.

Alcohol and Aggression

2007 ◽  
Vol 18 (7) ◽  
pp. 649-655 ◽  
Author(s):  
Peter R. Giancola ◽  
Michelle D. Corman
Keyword(s):  
Working Memory ◽  
Attention Allocation ◽  
Control Group ◽  
Placebo Control ◽  
Sequential Order ◽  
Allocation Model ◽  
Placebo Control Group ◽  
Electric Shocks ◽  
Moderate Load ◽  
Laboratory Task

This article presents the first systematic test of the attention-allocation model for alcohol-related aggression. According to this model, alcohol has a “myopic” effect on attentional capacity that presumably facilitates aggression by focusing attention on more salient provocative, rather than less salient inhibitory, cues in hostile situations. Aggression was assessed using a laboratory task in which mild electric shocks were received from, and administered to, a fictitious opponent. Study 1 demonstrated that a moderate-load cognitive distractor suppressed aggression in intoxicated subjects (to levels even lower than those exhibited by a placebo control group). Study 2 assessed how varying the magnitude of a distracting cognitive load affected aggression in the alcohol and placebo conditions. Results indicated that the moderate-load distraction used in Study 1 (i.e., holding four elements in sequential order in working memory) suppressed aggression best. Cognitive loads of larger and smaller magnitudes were not successful in attenuating aggression.

The effect of reflexology on quality of life in Iranian patients with breast cancer.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 90-90
Author(s):  
Shadan Pedramrazi
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Placebo Group ◽  
Test Group ◽  
Control Group ◽  
Relaxation Techniques ◽  
Control Groups ◽  
Significant Difference ◽  
And Control

90 Background: Breast cancer is one the most prevalent cancers among Iranian women. One of the complementary therapies is reflexology. The extant paper has been provided with the objective of determining the effect of reflexology on quality of life of patients with breast cancer undergoing chemotherapy in the breast disease center. Methods: This study is a randomized clinical trial which has been applied to 60 patients suffering from breast cancer under chemotherapy in breast diseases center, in 2012. The patients were selected randomly in three test, control and placebo groups. In test group, reflexology was implemented for 3 weeks and each session lasted half an hour. In placebo group, only relaxation techniques were implemented for 3 weeks, each session lasted 20-30 minutes. Control group received the routine therapies of breast cancer center. Results: Data were collected by standard questionnaires of EORTIC QLQ-C30.V.3 and EORTIC QLQ-BR23.V.3. The questionnaires were filled before intervention and two weeks after applying study. There was no significant difference in demographic characteristics or quality of life score of three groups, before intervention. Total score of quality of life was higher in interventional group compared to placebo group before and two weeks after intervention (p < 0.001) Results also indicated a significant difference in total score of quality of life between three test, placebo, and control groups after intervention (p < 0.001). A considerable improvement was noticed in the different aspects of quality of life in the test group compared to two other placebo and control groups. Conclusions: Reduction of pain, anxiety, nausea, and other symptoms related to cancer in patients suffering from cancer are assumed as the important cases of nursing cares focus, and precise nursing may diminish these symptoms considerably. Using reflexology in patients suffering from breast cancer may improve the quality of life as an effective method, and can be recommended for use in patients with breast cancer if it is supervised by health system personnel.

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