It is useful for the medical education fields and all who are interested in that.Background: Pain control in children is still a therapeutic dilemma. Preschool patients are affected from undesirable effects of postoperative pain more than adults. Tonsillectomy is associated with a high incidence of postoperative pain, not only complicating the recovery, but also delaying patients discharge. Objectives: Despite employing different surgical and anesthetic strategies in post-tonsillectomy pain relief, this is still a clinical problem. The study was designed to evaluate the efficacy of a low dose ketamine in post tonsillectomy pain relief. Patients and Methods: Our prospective randomized double blinded study enrolled 75 pediatric patients (3-10 years old) who were scheduled for a tonsillectomy procedure. Patients were randomly assigned to one of three groups receiving; intravenous (IV) ketamine 0.5mg/kg, subcutaneous (SC) ketamine 0.5 mg/kg and placebo at the end of the operation. Post-operative pain score was assessed using modified CHEOPS. Results: In our study we did not find any significant difference among the three groups regarding sex, age, and weight, duration of operation, hemodynamic stability, and nausea and vomiting. However, in ketamine groups, pain score and analgesic consumption were significantly lower (P < 0.00). The efficacy of the both ketamine groups was similar. Conclusions: The study demonstrated that the both subcutaneous and intravenous injections of ketamine, at the end of the operation, were safe and effective for post-tonsillectomy pain control. Ketamine reduced postoperative analgesic medications consumption without increasing the risk of complications.
Background Cell-free Mesenchymal stromal cells (MSCs) have been considered due to their capacity to modulate the immune system and suppress cytokine storms caused by SARS-CoV-2. This prospective randomized double-blind placebo-controlled clinical trial aimed to assess the safety and efficacy of secretome derived from allogeneic menstrual blood stromal cells (MenSCs) as a treatment in patients with severe COVID-19. Methods Patients with severe COVID-19 were randomized (1:1) to either MenSC-derived secretome treatment or the control group. Subjects received five intravenous infusions of 5 mL secretome or the same volume of placebo for five days and were monitored for safety and efficacy for 28 days after treatment. Adverse events, laboratory parameters, duration of hospitalization, clinical symptom improvement, dynamic of O2 saturation, lymphocyte number, and serial chest imaging were analyzed. Results All safety endpoints were observed without adverse events after 72 h of secretome injection. Within 28 days after enrollment, 7 patients (50%) were intubated in the treated group versus 12 patients (80%) in the control group. Overall, 64% of patients had improved oxygen levels within 5 days of starting treatment (P < 0.0001) and there was a survival rate of 57% in the treatment group compared to 28% in the control group was (P < 0.0001). Laboratory values revealed that significant acute phase reactants declined, with mean C-reactive protein, ferritin, and D-dimer reduction of 77% (P < 0.001), 43% (P < 0.001), and 42% (P < 0.05), respectively. Significant improvement in lymphopenia was associated with an increase in mean CD4+ and CD8+ lymphocyte counts of 20% (P = 0.06) and 15% (P < 0.05), respectively. Following treatment, percentage of pulmonary involvement showed a significant improvement in the secretome group (P < 0.0001). This improvement differed significantly between survivors and those who were dying (P < 0.005). Conclusions For the first time, this study demonstrated that in hospitalized patients with severe COVID-19, therapy with MenSCs-derived secretome leads to reversal of hypoxia, immune reconstitution, and downregulation of cytokine storm, with no adverse effects attributable to the treatment. Given these outcomes, it may be possible to use this type of treatment for serious inflammatory lung disease with a mechanism similar to COVID-19 in the future. However, it is necessary to evaluate the safety and efficacy of MenSCs-derived secretome therapy in clinical trials on a larger population of patients. Trial registration: ClinicalTrials.gov Identifier: NCT05019287. Registered 24AGUEST 2021, retrospectively registered, https://clinicaltrials.gov/ct2/show/record/NCT05019287. IRCT, IRCT20180619040147N6. Registered 04/01/2021.
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