ABSTRACT
ObjectivesConvalescent plasma (CP) as a passive source of neutralizing antibodies and immunomodulators is a century-old therapeutic option used for the management of viral diseases. We investigated its effectiveness for the treatment of COVID-19. DesignOpen-label, parallel-arm, phase II, multicentre, randomized controlled trial. SettingThirty-nine public and private hospitals across India. ParticipantsHospitalized, moderately ill confirmed COVID-19 patients (PaO2/FiO2: 200-300 or respiratory rate > 24/min and SpO2 [≤] 93% on room air). InterventionParticipants were randomized to either control (best standard of care (BSC)) or intervention (CP + BSC) arm. Two doses of 200 mL CP was transfused 24 hours apart in the intervention arm. Main Outcome MeasureComposite of progression to severe disease (PaO2/FiO2< 100) or all-cause mortality at 28 days post-enrolment. ResultsBetween 22nd April to 14th July 2020, 464 participants were enrolled; 235 and 229 in intervention and control arm, respectively. Composite primary outcome was achieved in 44 (18.7%) participants in the intervention arm and 41 (17.9%) in the control arm [aOR: 1.09; 95% CI: 0.67, 1.77]. Mortality was documented in 34 (13.6%) and 31 (14.6%) participants in intervention and control arm, respectively [aOR) 1.06 95% CI: -0.61 to 1.83]. InterpretationCP was not associated with reduction in mortality or progression to severe COVID-19. This trial has high generalizability and approximates real-life setting of CP therapy in settings with limited laboratory capacity. A priori measurement of neutralizing antibody titres in donors and participants may further clarify the role of CP in management of COVID-19. Trial registrationThe trial was registered with Clinical Trial Registry of India (CTRI); CTRI/2020/04/024775.
ABSTRACT
OBJECTIVES: To evaluate and compare the efficacy and safety of Intranasal (IN) Dexmedetomidine, Midazolam and Ketamine in producing moderate sedation among uncooperative pediatric dental patients. STUDY DESIGN: This randomized triple blind comparative study comprises of eighty four ASA grade I children of both sexes aged 4-14 years, who were uncooperative and could not be managed by conventional behavior management techniques. All the children were randomized to receive one of the four drug groups Dexmedetomidine 1 microg/ kg (D1), 1.5 microg/kg (D2), Midazolam 0.2 mg/kg (M1) and Ketamine 5 mg/kg (K1) through IN route. These drug groups were assessed for efficacy and safety by gauging overall success rate and by monitoring vital signs, respectively. RESULTS: The onset of sedation was significantly rapid with M1 and K1 as compared to D1 and D2 (p = < 0.001). The overall success rate was highest in D2 (85.7%) followed by D1 (81%), K1 (66.7%) and M1 (61.9%), however, the difference among them was not statistically significant (p = > 0.05). Even though all the vital signs were within physiological limits, there was significant reduction in pulse rate (PR) (p = < 0.001) and systolic blood pressure (SBP) (p = < 0.05) among D1 and D2 as compared to M1 and K1. D1, D2 and K1 produced greater intra- and post-operative analgesia as compared to M1. There were no significant adverse effects with any group. CONCLUSION: Dexmedetomidine, Midazolam and Ketamine, all the three drugs evaluated in the present study can be used safely and effectively through IN route in uncooperative pediatric dental patients for producing moderate sedation.
Subject(s)
Analgesics/administration & dosage , Anesthesia, Dental/methods , Conscious Sedation/methods , Dexmedetomidine/administration & dosage , Hypnotics and Sedatives/administration & dosage , Ketamine/administration & dosage , Midazolam/administration & dosage , Administration, Intranasal , Adolescent , Anesthesia Recovery Period , Blood Pressure/drug effects , Child , Child Behavior/drug effects , Child, Preschool , Dental Anxiety/prevention & control , Female , Heart Rate/drug effects , Humans , Male , Monitoring, Physiologic , Oxygen/blood , Pain, Postoperative/prevention & control , Patient Compliance , Patient Safety , Respiration/drug effects , Treatment OutcomeABSTRACT
Lithium is a psychotropic agent which is widely employed in the psychiatric practice throughout the world. The therapeutic index of lithium is low and an acute intoxication may appear, which may lead to death or a permanent disability. A frequent side effect of lithium is renal toxicity. The collecting tubules have been identified as the site of action of lithium, due to the down regulation of Acquaporin-2. The mast cells have been associated with a wide range of human renal diseases. They have been documented to be associated with interstitial fibrosis and an impaired renal function. We are reporting a case of a 42 year old male who was admitted with a history of an altered sensorium of short duration. He had bipolar disorder and was on lithium. Investigations revealed a severely compromised renal function. The patient's condition worsened and he expired. A necropsy was performed. The kidneys and the lungs were subjected to a histopathological examination. The kidneys showed a significant Chronic Tubulointerstitial Nephropathy [CTIN] and a considerable glomerular pathology. Toludine blue [1%] staining demonstrated mast cells in the interstitium and the connective tissue of the renal pelvis. This appears to be the first time that mast cells were demonstrated in a case of lithium induced nephropathy in humans. It may be hypothesized that mast cells may possibly play a role in lithium induced nephropathy as a concurrent mechanism.
