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Is Corticosteroid of No Use for Pediatric Patients with Common Cold Undergoing Anesthesia? A Randomized, Double-Blind, Clinical Trial.

ABSTRACT: Use of laryngeal mask airways (LMAs) has been advocated for children with upper respiratory tract infection (URI). However, no randomized trial has yet compared intravenous corticosteroids versus placebo in these patients.We hypothesized the lower incidence of postoperative cough (as the primary outcome) with intravenous corticosteroid versus placebo in pediatric patients with mild URI, who were anesthetized with LMA.A total of 210 patients with mild URI, aged 1 - 6 years, were included. The patients underwent full ophthalmic examination immediately (within few days). They were randomized to receive either intravenous corticosteroids (1 mg/kg of hydrocortisone and 0.1 mg/kg of dexamethasone 10 minutes prior to anesthesia induction) or placebo. Anesthesia was induced with sevoflurane. Following LMA insertion, the patients were maintained on anesthesia with spontaneous ventilation on N2O, O2, and 3% sevoflurane; LMA was removed under deep anesthesia. The outcomes were evaluated during anesthesia, recovery, and the first postoperative week.A total of 204 patients completed the trial. Cough, which was designated as the primary outcome, was not significantly different among patients receiving corticosteroids and placebo (31% vs. 34%; P = 0.7). Also, the incidence of laryngospasm (16% vs. 14%), apnea (9% VS 5%), desaturation (4% vs. 5%), bronchospasm (14% vs. 7%), vomiting (4% vs. 6%), and postoperative symptoms (8% vs. 7%) was not significantly different between the groups.Based on the present research, intravenous injection of corticosteroids has no beneficial effects for pediatric patients with minor uncomplicated URI (without a history of allergy), undergoing LMA anesthesia.

SUBMITTER: Kamranmanesh M

PROVIDER: S-EPMC5559701 | biostudies-other | 2017 Jun

REPOSITORIES: biostudies-other

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Project description:Background There is no clear evidence-based medicine that points to the most effective drug treatments for the common cold. In view of its ability to relieve symptoms and shorten the disease course, as well as its minimal side effects, traditional Chinese medicine (TCM) has been widely used to treat the common cold. However, there is a lack of strong evidence to support the clinical efficacy of TCM. This study aimed to evaluate the efficacy and safety of Ganduqing granules in the treatment of the common cold based on the network pharmacology analysis. Methods In this multicenter, randomized, double-blind, placebo-controlled trial, 60 eligible subjects will be randomly assigned to either the intervention group or the placebo group. The intervention group will be treated with Ganduqing granules, while the placebo group will be treated with placebo. After 5 days of intervention, the efficacy and safety of Ganduqing granules in the treatment of the common cold will be observed. The primary outcome is the time to clearance of all symptoms. The secondary outcomes included the levels of IL-6, TNF-α, SOD, and MDA in the peripheral blood, time to disappearance of primary symptoms and secondary symptoms, clinical symptom remission rate, and change in TCM syndrome score. Results Sixty participants completed the study. Ganduqing granules showed a greater effect on the time to clearance of all symptoms (P < 0.0001), nasal discharge (P=0.0124), fatigue and lack of strength (P=0.0138), dryness of the pharynx (P < 0.0001), pharyngalgia or dysphagia (P < 0.0001), and expectoration (P < 0.0431) compared with the placebo group. Participants in the intervention group had a greater decrease of IL-6 levels compared with the placebo group (P < 0.007); similar results were observed for the SOD (P < 0.033). However, the change in TNF-α and MDA levels in the intervention group was not significantly different from the placebo group. In addition, participants in the intervention group had a greater decrease of TCM syndrome score compared with the placebo group (P < 0.040). Conclusion Ganduqing granules could improve common cold symptoms, shorten the disease course, attenuated inflammation and oxidative stress, and provided objective evidence for the efficacy and safety of a Chinese herbal medicine in treating the common cold.

Project description:Background and objectivesMyasthenia gravis (MG) is an autoimmune disease characterized by dysfunction at the neuromuscular junction. Treatment frequently includes corticosteroids (CSs) and IV immunoglobulin (IVIG). This study was conducted to determine whether immune globulin (human), 10% caprylate/chromatography purified (IGIV-C) could facilitate CS dose reduction in CS-dependent patients with MG.MethodsIn this randomized double-blind placebo-controlled trial, CS-dependent patients with MG (Myasthenia Gravis Foundation of America Class II-Iva; AChR+) received a loading dose of 2 g/kg IGIV-C over 2 days (maximum 80 g/d) or placebo at week 0 (baseline). Maintenance doses (1 g/kg IGIV-C or placebo) were administered every 3 weeks through week 36. Tapering of CS was initiated at week 9 and continued through week 36 unless the patient worsened (quantitative MG score ≥4 points from baseline). CS doses were increased (based on the current CS dose) in patients who worsened. Patients were withdrawn if worsening failed to improve within 6 weeks or if a second CS increase was required. The primary efficacy end point (at week 39) was a ≥50% reduction in CS dose. Secondary and safety end points were assessed throughout the study and follow-up (weeks 42 and 45). The study results and full protocol are available at clinicaltrials.gov/ct2/show/NCT02473965.ResultsThe primary end point (≥50% reduction in CS dose) showed no significant difference between the IGIV-C treatment (60.0% of patients) and placebo (63.3%). There were no significant differences for secondary end points. Safety data indicated that IGIV-C was well tolerated.DiscussionIn this study, IGIV-C was not more effective than placebo in reducing daily CS dose. These results suggest that the effects of IGIV-C and CS are not synergistic and may be mechanistically different.Trial registration informationThe trial was registered on clinicaltrialsregister.eu (EudraCT #: 2013-005099-17) and clinicaltrials.gov (identifier NCT02473965).Classification of evidenceThis study provides Class II evidence that IVIG infusions in adult patients with MG do not increase the percentage of patients achieving a ≥50% reduction in corticosteroid dose compared with placebo.

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Is Corticosteroid of No Use for Pediatric Patients with Common Cold Undergoing Anesthesia? A Randomized, Double-Blind, Clinical Trial.

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