scholarly journals A 3-day course of 1 mg/kg versus 2 mg/kg bodyweight prednisolone for 1- to 5-year-old children with acute moderate exacerbation of asthma: a randomized double-blind noninferiority trial

2020 ◽  
Author(s):  
Pavan Kumar Buddala ◽  
Venkatesh Chandrasekaran ◽  
K T Harichandrakumar
Keyword(s):  
Side Effect ◽  
Oral Prednisolone ◽  
High Dose ◽  
Side Effect Profile ◽  
Double Blind ◽  
Paediatric Emergency ◽  
Noninferiority Trial ◽  
Assessment Measure ◽  
Frequent Vomiting ◽  
The Difference

Abstract Background Even though the guidelines on the management of preschool asthma recommend early use of corticosteroids for acute moderate-to-severe exacerbations, considerable variation exists with regard to type and dose of steroids. Objectives To compare the clinical outcomes and side effect profile between 1 mg/kg/day and 2 mg/kg/day of oral prednisolone when administered for 3 days in preschool children with acute moderate asthma exacerbations. Study Design and Setting Randomized double-blind noninferiority trial was done in the paediatric emergency of a teaching hospital. Patients, Interventions, and Outcomes A total of 128 children aged 1 to 5 years who presented to the paediatric emergency with acute moderate exacerbation of asthma were enrolled. They were randomized into two groups. One group received 1 mg/kg/day and the other 2 mg/kg/day of oral prednisolone for 3 days. Severity of asthma exacerbation was measured by Pediatric Respiratory Assessment Measure (PRAM) score. The PRAM scores, wheeze recurrence, and side effect profile were compared and analyzed between the two groups. Results The difference in the PRAM scores at 1, 2, 3, and 4 hours after intervention between the two groups was statistically insignificant. Need for escalation of therapy, salbutamol nebulization, time for resolution of symptoms, and recurrence of wheeze were similar between the two groups. Vomiting was significantly less frequent in low-dose group with a relative risk of 0.19 to 0.99 compared to high-dose prednisolone. Conclusion Prednisolone at a dose of 1 mg/kg/day was not inferior to 2 mg/kg/day in terms of clinical improvement and recurrence of wheeze within 1 week and has less frequent vomiting compared to higher dose.

A Double-Blind Comparison of Meptazinol versus Distalgesic in Acute or Chronic Pain Presenting to the General Practitioner

1982 ◽  
Vol 10 (2) ◽  
pp. 104-108 ◽  
Author(s):  
A G Wade ◽  
Peter J Ward
Keyword(s):  
Chronic Pain ◽  
General Practitioner ◽  
Side Effect ◽  
Time Effect ◽  
Side Effect Profile ◽  
Double Blind ◽  
Blind Comparison ◽  
Blind Fashion

The results of treating acute or chronic pain with Distalgesic were compared in a double-blind fashion with the new partial antagonist analgesic meptazinol. Both drugs had similar analgesic time effect profiles and both were acceptable to doctor and patients. However the side-effect profile was better for meptazinol than Distalgesic and so meptazinol may be a useful alternative to Distalgesic in the treatment of everyday pain states.

scholarly journals Impact of oral corticosteroids on respiratory outcomes in acute preschool wheeze: a randomised clinical trial

2020 ◽  
pp. archdischild-2020-318971
Author(s):  
Alexandra Wallace ◽  
Owen Sinclair ◽  
Michael Shepherd ◽  
Jocelyn Neutze ◽  
Adrian Trenholme ◽  
...  
Keyword(s):  
Preschool Children ◽  
Admission Rate ◽  
Oral Prednisolone ◽  
Respiratory Illness ◽  
Randomised Clinical Trial ◽  
Double Blind ◽  
Intention To Treat ◽  
Assessment Measure ◽  
Oral Corticosteroids ◽  
Respiratory Outcomes

ObjectiveTo determine if administration of oral prednisolone to preschool children with acute wheeze alters respiratory outcomes.DesignDouble-blind, randomised, placebo-controlled equivalence trial.SettingThree hospitals in New Zealand.Patients477 children aged 24–59 months with acute wheeze associated with respiratory illness.Interventions2 mg/kg (maximum 40 mg) oral prednisolone or similar placebo, once daily for 3 days.Main outcome measuresPrimary outcome was change in Preschool Respiratory Assessment Measure (PRAM) score 24 hours after intervention. Secondary outcomes included PRAM score at 4 hours, length of emergency department and inpatient stays, admission and representation rates, time to return to normal activities and use of additional oral prednisolone or intravenous medications. Analysis was by intention-to-treat.ResultsThere was no difference between groups for change in PRAM score at 24 hours (difference between means −0.39, 95% CI −0.84 to 0.06, p=0.09). Absolute PRAM score was lower in the prednisolone group at 4 hours (median (IQR) 1 (0–2) vs 2 (0–3), p=0.01) and 24 hours (0 (0–1) vs 0 (0–1), p=0.01), when symptoms had resolved for most children regardless of initial treatment. Admission rate, requirement for additional oral prednisolone and use of intravenous medication were lower in the prednisolone group, although there were no differences between groups for time taken to return to normal activities or rates of representation within 7 days.ConclusionOral prednisolone does not alter respiratory outcomes at 24 hours or beyond in preschool children presenting with acute wheeze.

A Multicentre Double Blind Trial of Fluoxetine versus Amitriptyline in the Treatment of Depressive Illness

1993 ◽  
Vol 27 (1) ◽  
pp. 49-55 ◽  
Author(s):  
Fiona K. Judd ◽  
Kate Moore ◽  
Trevor R. Norman ◽  
Graham D. Burrows ◽  
Ramesh K. Gupta ◽  
...  
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Serotonin Reuptake ◽  
Depressive Illness ◽  
Fixed Dose ◽  
Side Effect Profile ◽  
Double Blind Trial ◽  
Double Blind ◽  
Antidepressant Efficacy ◽  
To Receive

The antidepressant efficacy and side effect profile of a fixed dose of 20 mg/day of fluoxetine, a specific serotonin reuptake inhibitor, were compared to those of amitriptyline. Fifty-eight patients with DSM-III-R depression were randomly assigned to receive either fluoxetine or amitriptyline. Fifty-six patients (fluoxetine N = 23, amitriptyline N = 23) completed the 6 week study. Comparable antidepressant efficacy was demonstrated for the two drugs. Patients taking fluoxetine reported less side-effects than those taking amitriptyline.

scholarly journals P001 Safety, tolerability, and efficacy of 1 month of atomoxetine plus oxybutynin in obstructive sleep apnoea

2021 ◽  
Vol 2 (Supplement_1) ◽  
pp. A22-A22
Author(s):  
A Aishah ◽  
K Loffler ◽  
B Tonson ◽  
S Mukherjee ◽  
R Adams ◽  
...  
Keyword(s):  
Obstructive Sleep Apnoea ◽  
Side Effect ◽  
Vital Signs ◽  
Upper Airway ◽  
Sleep Apnoea ◽  
Side Effect Profile ◽  
Double Blind ◽  
Phone Calls ◽  
Obstructive Sleep ◽  
Single Night

Abstract Introduction Single-night studies with noradrenergic and anti-muscarinics have recently been shown to improve upper-airway function and reduce obstructive sleep apnoea (OSA) severity. This study aimed to determine the safety, tolerability, and efficacy profile of longer-term use of different doses of the noradrenergic agent atomoxetine combined with the anti-muscarinic oxybutynin (ato-oxy) in people with OSA. Methods Thirty-nine people with predominantly severe OSA received either 80/5mg ato-oxy, 40/5mg ato-oxy, 40/2.5mg ato-oxy or placebo nightly for 30 days according to a double-blind, randomised, parallel design. Safety and tolerability were assessed via weekly phone calls for adverse events, vital signs and objective measures of alertness and memory. Participants completed 3 in-laboratory sleep studies (baseline, night 1 and night 30) to assess efficacy. Results Side effects were generally mild and consistent with the known side-effect profile of each drug alone (e.g. dose-dependent increases in dry mouth with oxybutynin). Heart rate increased by night 30 in two of the drug arms versus placebo (e.g. 80/5mg ~9 beats/min, p=0.01). Blood pressure and measures of alertness and memory did not change between conditions. AHI4 and hypoxic burden decreased by ~50% in the 80/5mg arm on night 1 with similar magnitude reductions at night 30. ~50% of participants indicated willingness to continue taking the medication post-study. Discussion 1 month of nightly noradrenergic and anti-muscarinic combination therapy is generally well-tolerated with a side effect profile consistent with each agent alone. These findings also further highlight the potential to target noradrenergic and anti-muscarinic mechanisms for OSA pharmacotherapy development.

scholarly journals Comparative efficacy and side-effect profile of ketamine and esketamine in the treatment of unipolar and bipolar depression: protocol for a systematic review and network meta-analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043457
Author(s):  
Zhiqing Zhan ◽  
Xichao Wang ◽  
Qing Chen ◽  
Zhidai Xiao ◽  
Bin Zhang
Keyword(s):  
Side Effect ◽  
Web Application ◽  
Bipolar Depression ◽  
Data Extraction ◽  
Meta Analysis ◽  
Antidepressant Drugs ◽  
Side Effect Profile ◽  
Open Label ◽  
Double Blind ◽  
Reference Selection

IntroductionDespite a range of antidepressant drugs and therapies, approximately one-third of patients fail to achieve meaningful recovery, prompting the urgent need for more effective treatment for depression. Several open-label studies randomised controlled trials (RCTs) and meta-analyses have been conducted to confirm the therapeutic efficacy and side effects of ketamine and esketamine. Esketamine is (S)- enantiomer of ketamine; however, there is limited evidence comparing esketamine and ketamine in treating unipolar and bipolar depression have been published so far.Methods and analysisWe will include all double-blind RCTs comparing efficacy and side-effect profile of ketamine and esketamine in the treatment of unipolar and bipolar depression. Our primary outcomes will be study-defined response at endpoint assessment; dropouts due to adverse events and other adverse drug reactions. Published studies will be retrieved through relevant database searches. Reference selection and data extraction will be independently completed by two investigators, resolving inconsistencies by consensus or a discussion with the third investigator. For each outcome, we will undertake a network meta-analysis to synthesise all evidence. Local and global methods will be used to evaluate consistency. We will assess the quality of evidence contributing to network estimates with the Confidence in Network Meta-Analysis web application.Ethics and disseminationThis work does not require ethics approval as it will be based on published studies. This review will be published in peer-reviewed journals.PROSPERO registration numberCRD42020201559.

The Effects of a Caffeine Placebo and Experimenter Expectation on Blood Pressure, Heart Rate, Well-Being, and Cognitive Performance

2001 ◽  
Vol 6 (1) ◽  
pp. 15-25 ◽  
Author(s):  
Harald Walach ◽  
Stefan Schmidt ◽  
Yvonne-Michelle Bihr ◽  
Susanne Wiesch
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Cognitive Task ◽  
Well Being ◽  
Control Group ◽  
Double Blind ◽  
Main Effect ◽  
The Difference ◽  
Being There ◽  
To Receive

We studied the effect of experimenter expectations and different instructions in a balanced placebo design. 157 subjects were randomized into a 2 × 4 factorial design. Two experimenters were led to expect placebos either to produce physiological effects or not (pro- vs. antiplacebo). All subjects except a control group received a caffeine placebo. They were either made to expect coffee, no coffee, or were in a double-blind condition. Dependent measures were blood pressure, heart rate, well-being, and a cognitive task. There was one main effect on the instruction factor (p = 0.03) with the group “told no caffeine” reporting significantly better well-being. There was one main effect on the experimenter factor with subjects instructed by experimenter “proplacebo” having higher systolic blood pressure (p = 0.008). There was one interaction with subjects instructed by experimenter “proplacebo” to receive coffee doing worse in the cognitive task than the rest. Subjects instructed by experimenter “antiplacebo” were significantly less likely to believe the experimental instruction, and that mostly if they had been instructed to receive coffee. Contrary to the literature we could not show an effect of instruction, but there was an effect of experimenters. It is likely, however, that these experimenter effects were not due to experimental manipulations, but to the difference in personalities.

Valproic Acid:

1999 ◽  
Vol 16 (2) ◽  
pp. 130-136 ◽  
Author(s):  
Sayonara Beatriz Ranciaro Fagundes
Keyword(s):  
Health Care ◽  
Valproic Acid ◽  
Antiepileptic Drug ◽  
Detailed Analysis ◽  
Side Effect ◽  
Side Effect Profile ◽  
Care Givers

Clinical pharmacologists, neurologists, and all health care givers must consider the efficacy, safety, and side effect profile of a given antiepileptic drug when determining which drug is best for a given patient.The purpose of this study was to investigate valproic acid with a detailed analysis of the different reports.

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