Tepid sponging plus dipyrone versus dipyrone alone for reducing body temperature in febrile children

CONTEXT AND OBJECTIVE: The role of tepid sponging to promote fever control in children is controversial. We did not find any studies reporting on the effectiveness of tepid sponging in addition to dipyrone. The aim of this study was to compare the effects of tepid sponging plus dipyrone with dipyrone alone for reducing fever. DESIGN AND SETTING: A randomized clinical trial was undertaken at Instituto Materno-Infantil Professor Fernando Figueira, Recife, Pernambuco. METHODS: Children from six months to five years old with axillary temperature greater than 38 ºC in the emergency ward between January and July 2006 were eligible. One hundred and twenty children were randomly assigned to receive oral dipyrone (20 mg/kg) or oral dipyrone and tepid sponging for 15 minutes. The primary outcome was mean temperature reduction after 15, 30, 60, 90 and 120 minutes. Secondary outcomes were crying and irritability. RESULTS: 106 children finished the study. After the first 15 minutes, the fall in axillary temperature was significantly greater in the sponged group than in the control group (p < 0.001). From 30 to 120 minutes, better fever control was observed in the control group. Crying and irritability were observed respectively in 52% and 36% of the sponged children and in none and only two of the controls. CONCLUSIONS: Tepid sponging plus dipyrone cooled faster during the first 15 minutes, but dipyrone alone presented better fever control over the two-hour period. Tepid sponging caused mild discomfort, crying and irritability for most of the children.

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Convalescent Plasma for COVID-19: A multicenter, randomized clinical trial

10.1101/2020.08.26.20182444 ◽

2020 ◽

Cited By ~ 7

Author(s):

Cristina Avendano-Sola ◽

Antonio Ramos-Martinez ◽

Elena Munez-Rubio ◽

Belen Ruiz-Antoran ◽

Rosa Malo de Molina ◽

...

Keyword(s):

Clinical Trial ◽

Mechanical Ventilation ◽

Randomized Clinical Trial ◽

Strong Dependence ◽

Standard Of Care ◽

Ordinal Scale ◽

Control Group ◽

Standard Of Care Treatment ◽

And Control ◽

To Receive

Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).

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A randomized clinical trial assessing a pragmatic intervention to improve supportive care for family caregivers of patients with lung cancer

Palliative & Supportive Care ◽

10.1017/s1478951520000711 ◽

2020 ◽

pp. 1-8

Author(s):

Michèle Aubin ◽

Lucie Vézina ◽

René Verreault ◽

Sébastien Simard ◽

Jean-François Desbiens ◽

...

Keyword(s):

Lung Cancer ◽

Clinical Trial ◽

Supportive Care ◽

Randomized Clinical Trial ◽

Cancer Patients ◽

Family Caregivers ◽

Control Group ◽

Oncology Nurse ◽

High Distress ◽

Secondary Outcomes

Abstract Objective Family caregivers (FCs) of cancer patients often experience high distress. This randomized clinical trial assessed the feasibility and preliminary effects of an intervention to improve FC supportive care. Method A pragmatic and minimal intervention to improve FC supportive care was developed and pretested with FCs, oncology team, and family physicians to assess its relevance and acceptability. Then, FCs of lung cancer patients were randomized to the intervention or the control group. The intervention included (1) systematic FC distress screening and problem assessment in the first months after their relative cancer diagnosis, and every 2 months after; (2) privileged contact with an oncology nurse to address FC problems, provide emotional support and skills to play their caregiving role; (3) liaison with the family physician of FCs reporting high distress (distress thermometer score ≥4/10) to involve them in the provision of supportive care. Distress, the primary outcome, was measured every 3 months, for 9 months. Secondary outcomes included quality of life, caregiving preparedness, and perceived burden. At the end of their participation, a purposive sample of FC from the experimental group was individually interviewed to assess the intervention usefulness. Content analysis was performed. Results A total of 109 FCs participated in the trial. FC distress decreased over time, but this reduction was observed in both groups. Similar results were found for secondary outcomes. However, FCs who received the intervention felt better prepared in caregiving than controls (p = 0.05). All 10 interviewed FCs valued the intervention, even though they clearly underused it. Knowing they could contact the oncology nurse served as a security net. Significance of results Although the intervention was not found effective, some of its aspects were positively perceived by FCs. As many of them experience high distress, an improved intervention should be developed to better support them.

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A Randomized Clinical Trial of the Efficacy and Safety of Interferon β-1a in Treatment of Severe COVID-19

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.01061-20 ◽

2020 ◽

Vol 64 (9) ◽

Cited By ~ 30

Author(s):

Effat Davoudi-Monfared ◽

Hamid Rahmani ◽

Hossein Khalili ◽

Mahboubeh Hajiabdolbaghi ◽

Mohamadreza Salehi ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Response ◽

Randomized Clinical Trial ◽

Primary Outcome ◽

Discharge Rate ◽

Control Group ◽

Efficacy And Safety ◽

Interferon Β ◽

Mortality Effect ◽

Overall Mortality

ABSTRACT To the best of our knowledge, there is no published study on the use of interferon β-1a (IFN β-1a) in the treatment of severe COVID-19. In this randomized clinical trial, the efficacy and safety of IFN β-1a were evaluated in patients with severe COVID-19. Forty-two patients in the interferon group received IFN β-1a in addition to the national protocol medications (hydroxychloroquine plus lopinavir-ritonavir or atazanavir-ritonavir). Each 44-μg/ml (12 million IU/ml) dose of interferon β-1a was subcutaneously injected three times weekly for two consecutive weeks. The control group consisted of 39 patients who received only the national protocol medications. The primary outcome of the study was time to reach clinical response. Secondary outcomes were duration of hospital stay, length of intensive care unit stay, 28-day mortality, effect of early or late administration of IFN on mortality, adverse effects, and complications during the hospitalization. Between 29 February and 3 April 2020, 92 patients were recruited, and a total of 42 patients in the IFN group and 39 patients in the control group completed the study. As the primary outcome, time to the clinical response was not significantly different between the IFN and the control groups (9.7 ± 5.8 versus 8.3 ± 4.9 days, respectively, P = 0.95). On day 14, 66.7% versus 43.6% of patients in the IFN group and the control group, respectively, were discharged (odds ratio [OR], 2.5; 95% confidence interval [CI], 1.05 to 6.37). The 28-day overall mortality was significantly lower in the IFN than the control group (19% versus 43.6%, respectively, P = 0.015). Early administration significantly reduced mortality (OR, 13.5; 95% CI, 1.5 to 118). Although IFN did not change the time to reach the clinical response, adding it to the national protocol significantly increased discharge rate on day 14 and decreased 28-day mortality. (This study is in the Iranian Registry of Clinical Trials under identifier IRCT20100228003449N28.)

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The Role of Pulsatile Cold Compression in Edema Resolution Following Ankle Fractures: A Randomized Clinical Trial

Foot & Ankle International ◽

10.1177/107110070202301105 ◽

2002 ◽

Vol 23 (11) ◽

pp. 999-1002 ◽

Cited By ~ 21

Author(s):

Steve Mora ◽

Charalampos G. Zalavras ◽

Lingjun Wang ◽

David B. Thordarson

Keyword(s):

Clinical Trial ◽

Patient Satisfaction ◽

Randomized Clinical Trial ◽

Bed Rest ◽

Ankle Fractures ◽

Control Group ◽

Study Group ◽

Time Points ◽

Cold Compression

Twenty-four patients with displaced ankle fractures awaiting surgery were randomized to a study (n = 11) or a control group (n = 13). In the study group, patients had a pulsatile cold compression (PCC) device applied to their ankle, and remained at bed rest with the extremity elevated while awaiting surgery. In the control group patients remained in a posterior molded splint instead of the PCC device. Baseline circumferential measurements of the ankle were obtained, followed by measurements at 24-hour increments to evaluate edema resolution. In addition, patient satisfaction with use of the PCC device was evaluated with a scale ranging from 1 to 4. The median decrease of circumference in the study group compared to the control group was 0.5 cm vs. 0.1 cm at 24 hours (p=0.005), 0.9 cm vs. 0.4 cm at 48 hours (p<0.001), and 1.2 cm vs. 0.5 cm at 72 hours (p=0.009). The ratio of the decrease in circumference relative to the circumference of the normal ankle was significantly higher in the PCC group compared to the control group at all time points. All patients in the PCC group were satisfied with the device (median satisfaction score = 4). The PCC device was well tolerated and resulted in a significantly greater reduction of ankle circumference at 24, 48, and 72 hours after its application, compared to splinting and elevation alone. The PCC device facilitates edema resolution following ankle fractures.

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Efficacy of Hydroxychloroquine in Patients with COVID-19 (Chen et al., 2020): Moderate Evidence for a Treatment Effect on Pneumonia

10.31234/osf.io/7nk8z ◽

2020 ◽

Cited By ~ 1

Author(s):

Eric-Jan Wagenmakers ◽

Quentin Frederik Gronau

Keyword(s):

Clinical Trial ◽

Treatment Group ◽

Body Temperature ◽

Randomized Clinical Trial ◽

Treatment Effect ◽

Recovery Time ◽

The Body ◽

Control Group ◽

Moderate Evidence ◽

Temperature Recovery

A recent randomized clinical trial assessed the efficacy of hydroxychloroquine (HCQ) in the treatment of patients with common coronavirus disease-19 (COVID-19). 1 The results showed that “the body temperature recovery time and the cough remission time were significantly shortened in the HCQ treatment group. Besides, a larger proportion of patients with improved pneumonia in the HCQ treatment group (80.6%, 25 of 31) compared with the control group (54.8%, 17 of 31).” A Bayesian reanalysis of the pneumonia data provides support for the hypothesis that HCQ improves pneumonia in patients with COVID-19. However, the degree of this support is moderate. In line with the authors’ conclusion, more data are needed to draw definite conclusions.

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Surfactant Administration in Preterm Neonates Using Laryngeal Mask Airway: A Randomized Clinical Trial

ACTA MEDICA IRANICA ◽

10.18502/acta.v57i6.1877 ◽

2019 ◽

Author(s):

Elaheh Amini ◽

Mahdi Sheikh ◽

Mamak Shariat ◽

Hosein Dalili ◽

Negin Azadi ◽

...

Keyword(s):

Clinical Trial ◽

Laryngeal Mask Airway ◽

Endotracheal Tube ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Laryngeal Mask ◽

Control Group ◽

Premature Neonates ◽

Surfactant Administration ◽

To Receive

Abstract- In this study, we aimed to compare the efficacy of laryngeal mask airway (LMA) versus endotracheal tube in the early rescue surfactant administration in premature neonates with respiratory distress syndrome (RDS). This randomized, clinical trial evaluated 60 premature neonates with RDS. Numbered envelopes randomly assigned 30 neonates to the intervention group to receive 2.5 ml/kg/dose surfactant (Curosurf) via LMA and 30 to the control group to receive 2.5 ml/kg/dose surfactant via an endotracheal tube using the INSURE technique, exclusively during the first two hours of life. There were no differences in the requirement for mechanical ventilation (23.3% vs. 20%, P=0.75), requirement for second dose surfactant (13.3% vs. 6.7%, P=0.67), bronchopulmonary dysplasia (13.3% vs. 6.7%, P=0.67), pneumothorax (6.7% vs. 0%, P=0.49), and intraventricular hemorrhage (10% vs. 10%, P=1) between neonates who received surfactant via LMA versus those who received surfactant via endotracheal tube. LMA seems to be an effective and less invasive alternative to endotracheal intubation for surfactant delivery in premature neonates with RDS.

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Effect of probiotic supplement (kidilact) on prevention of acute diarrhea in children: a double-blind randomized clinical trial

International Journal of Research in Medical Sciences ◽

10.18203/2320-6012.ijrms20172595 ◽

2017 ◽

Vol 5 (7) ◽

pp. 2861

Author(s):

Mehran Hesaraki

Keyword(s):

Clinical Trial ◽

Heart Rate ◽

Body Temperature ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Vital Signs ◽

Control Group ◽

Early Recovery ◽

Double Blind ◽

Viral Diarrhea

Background: Acute viral diarrhea is one of the most common diseases in children, which is associated with high risk of mortality. The present study aimed to determine the effect of Kidilact on the treatment of children with acute diarrhea.Methods: This double-blind randomized clinical trial was conducted on 84 children aged 6-60 months with diarrhea, hospitalized in pediatric ward of Amir al-Mu'minin hospital of Zabol, Iran. The patients who met the inclusion criteria were included and assigned to the control and treatment groups (42 patients in each group). Data collection instruments included clinical examination of participants in terms of gender, medication, diet, stool test, weight, average heart rate, average respiratory rate, average body temperature, and average frequency of defecation Data was analyzed with descriptive and analytical tests (chi-square, Fisher's exact test, t-test, etc.) in SPSS-21.Results: Body temperature, heart rate, and frequency of defecation significantly reduced in the intervention group after three days (p<0.05). In addition, weight gain presented an improving trend in the intervention group, but not significantly different from the control group (p<0.05).Conclusions: Findings indicated that the use of Kidilact may be helpful in the treatment of acute viral diarrhea in children and play a key role in early recovery, reduction of disease severity, and improvement of vital signs in these patients.

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Efficacy and safety of interferon beta-1a in treatment of severe COVID-19: A randomized clinical trial

10.1101/2020.05.28.20116467 ◽

2020 ◽

Cited By ~ 9

Author(s):

Effat Davoudi-Monfared ◽

Hamid Rahmani ◽

Hossein Khalili ◽

Mahboubeh Hajiabdolbaghi ◽

Mohamadreza Salehi ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Response ◽

Randomized Clinical Trial ◽

Primary Outcome ◽

Interferon Beta ◽

Discharge Rate ◽

Standard Of Care ◽

Control Group ◽

Efficacy And Safety ◽

Mortality Effect

Objectives: To the best of our knowledge, there is no published study regarding use of IFN beta-1a in the treatment of severe COVID-19. In this randomized clinical trial efficacy and safety of IFN β-1a has been evaluated in patients with severe COVID-19. Methods: Forty-two patients in the interferon group received IFN beta-1a in addition to the standard of care. Each 44 micrograms/ml (12 million IU/ml) of interferon beta-1a was subcutaneously injected three times weekly for two consecutive weeks. The control group received only the standard of care. Primary outcome of study was time to reach clinical response. Secondary outcomes duration of hospital stay, length of ICU stay, 28-day mortality, effect of early or late administration of IFN on mortality, adverse effects and complications during the hospitalization. Results: As primary outcome, time to the clinical response was not significantly different between the IFN and the control groups (9.7 +/- 5.8 vs. 8.3 +/- 4.9 days respectively, P=0.95). On day 14, 66.7% vs. 43.6% of patients in the IFN group and the control group were discharged, respectively (OR= 2.5; 95% CI: 1.05- 6.37). The 28-day overall mortality was significantly lower in the IFN then the control group (19% vs. 43.6% respectively, p= 0.015). Early administration significantly reduced mortality (OR=13.5; 95% CI: 1.5-118). Conclusion: Although did not change time to reach the clinical response, adding to the standard of care significantly increased discharge rate on day 14 and decreased 28-day mortality. Clinical Trial Registration ID #IRCT20100228003449N28.

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Reducing Sitting Time in Obese Older Adults: The I-STAND Randomized Controlled Trial

Journal of Aging and Physical Activity ◽

10.1123/japa.2019-0470 ◽

2020 ◽

Vol 28 (6) ◽

pp. 864-874 ◽

Cited By ~ 1

Author(s):

Dori E. Rosenberg ◽

Melissa L. Anderson ◽

Anne Renz ◽

Theresa E. Matson ◽

Amy K. Lee ◽

...

Keyword(s):

Older Adults ◽

Primary Outcome ◽

Controlled Trial ◽

Sitting Time ◽

Group Differences ◽

Control Group ◽

Linear Regression Models ◽

Health Promoting ◽

Secondary Outcomes ◽

To Receive

Background: The authors tested the efficacy of the “I-STAND” intervention for reducing sitting time, a novel and potentially health-promoting approach, in older adults with obesity. Methods: The authors recruited 60 people (mean age = 68 ± 4.9 years, 68% female, 86% White; mean body mass index = 35.4). The participants were randomized to receive the I-STAND sitting reduction intervention (n = 29) or healthy living control group (n = 31) for 12 weeks. At baseline and at 12 weeks, the participants wore activPAL devices to assess sitting time (primary outcome). Secondary outcomes included fasting glucose, blood pressure, and weight. Linear regression models assessed between-group differences in the outcomes. Results: The I-STAND participants significantly reduced their sitting time compared with the controls (–58 min per day; 95% confidence interval [–100.3, –15.6]; p = .007). There were no statistically significant changes in the secondary outcomes. Conclusion: I-STAND was efficacious in reducing sitting time, but not in changing health outcomes in older adults with obesity.

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Perioperative synbiotics administration decreases postoperative infections in patients with colorectal cancer: a randomized, double-blind clinical trial

Revista do Colégio Brasileiro de Cirurgiões ◽

10.1590/0100-69912017006004 ◽

2017 ◽

Vol 44 (6) ◽

pp. 567-573 ◽

Cited By ~ 12

Author(s):

ALINE TABORDA FLESCH ◽

STAEL T. TONIAL ◽

PAULO DE CARVALHO CONTU ◽

DANIEL C. DAMIN

Keyword(s):

Colorectal Cancer ◽

Clinical Trial ◽

Elective Surgery ◽

Lactobacillus Rhamnosus ◽

Control Group ◽

Double Blind ◽

Double Blind Clinical Trial ◽

Colorectal Cancer Patients ◽

To Receive

ABSTRACT Objective: to evaluate the effect of perioperative administration of symbiotics on the incidence of surgical wound infection in patients undergoing surgery for colorectal cancer. Methods: We conducted a randomized clinical trial with colorectal cancer patients undergoing elective surgery, randomly assigned to receive symbiotics or placebo for five days prior to the surgical procedure and for 14 days after surgery. We studied 91 patients, 49 in the symbiotics group (Lactobacillus acidophilus 108 to 109 CFU, Lactobacillus rhamnosus 108 to 109 CFU, Lactobacillus casei 108 to 109 CFU, Bifi dobacterium 108 to 109 CFU and fructo-oligosaccharide (FOS) 6g) and 42 in the placebo group. Results: surgical site infection occurred in one (2%) patient in the symbiotics group and in nine (21.4%) patients in the control group (p=0.002). There were three cases of intraabdominal abscess and four cases of pneumonia in the control group, whereas we observed no infections in patients receiving symbiotics (p=0.001). Conclusion: the perioperative administration of symbiotics significantly reduced postoperative infection rates in patients with colorectal cancer. Additional studies are needed to confirm the role of symbiotics in the surgical treatment of colorectal cancer.

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