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1.
CNS Neurosci Ther ; 30(5): e14748, 2024 05.
Article in English | MEDLINE | ID: mdl-38727518

ABSTRACT

AIMS: To investigate the characteristics of dynamic cerebral autoregulation (dCA) after intravenous thrombolysis (IVT) and assess the relationship between dCA and prognosis. METHODS: Patients with unilateral acute ischemic stroke receiving IVT were prospectively enrolled; those who did not were selected as controls. All patients underwent dCA measurements, by quantifying the phase difference (PD) and gain, at 1-3 and 7-10 days after stroke onset. Simultaneously, two dCA-based nomogram models were established to verify the predictive value of dCA for patients with mild-to-moderate stroke. RESULTS: Finally, 202 patients who received IVT and 238 who did not were included. IVT was positively correlated with higher PD on days 1-3 and 7-10 after stroke onset. PD values in both sides at 1-3 days after stroke onset and in the affected side at 7-10 days after onset were independent predictors of unfavorable outcomes in patients who received IVT. Additionally, in patients with mild-to-moderate stroke who received IVT, the dCA-based nomogram models significantly improved the risk predictive ability for 3-month unfavorable outcomes. CONCLUSION: IVT has a positive effect on dCA in patients with acute stroke; furthermore, dCA may be useful to predict the prognosis of patients with IVT.


Subject(s)
Homeostasis , Ischemic Stroke , Thrombolytic Therapy , Humans , Male , Female , Aged , Middle Aged , Prognosis , Thrombolytic Therapy/methods , Homeostasis/physiology , Homeostasis/drug effects , Ischemic Stroke/drug therapy , Ischemic Stroke/physiopathology , Fibrinolytic Agents/administration & dosage , Fibrinolytic Agents/therapeutic use , Cerebrovascular Circulation/physiology , Cerebrovascular Circulation/drug effects , Prospective Studies , Tissue Plasminogen Activator/administration & dosage , Tissue Plasminogen Activator/therapeutic use , Administration, Intravenous , Predictive Value of Tests , Aged, 80 and over , Nomograms , Stroke/drug therapy , Stroke/physiopathology
2.
AAPS J ; 26(3): 60, 2024 May 10.
Article in English | MEDLINE | ID: mdl-38730115

ABSTRACT

Subcutaneous (SC) administration of therapeutic proteins is perceived to pose higher risk of immunogenicity when compared with intravenous (IV) route of administration (RoA). However, systematic evaluations of clinical data to support this claim are lacking. This meta-analysis was conducted to compare the immunogenicity of the same therapeutic protein by IV and SC RoA. Anti-drug antibody (ADA) data and controlling variables for 7 therapeutic proteins administered by both IV and SC routes across 48 treatment groups were analyzed. RoA was the primary independent variable of interest while therapeutic protein, patient population, adjusted dose, and number of ADA samples were controlling variables. Analysis of variance was used to compare the ADA incidence between IV and SC RoA, while accounting for controlling variables and potential interactions. Subsequently, 10 additional therapeutic proteins with ADA data published for both IV and SC administration were added to the above 7 therapeutic proteins and were evaluated for ADA incidence. RoA had no statistically significant effect on ADA incidence for the initial dataset of 7 therapeutic proteins (p = 0.55). The only variable with a significant effect on ADA incidence was the therapeutic protein. None of the other controlling variables, including their interactions with RoA, was significant. When all data from the 17 therapeutic proteins were pooled, there was no statistically significant effect of RoA on ADA incidence (p = 0.81). In conclusion, there is no significant difference in ADA incidence between the IV and SC RoA, based on analysis of clinical ADA data from 17 therapeutic proteins.


Subject(s)
Administration, Intravenous , Humans , Injections, Subcutaneous , Antibodies/administration & dosage , Antibodies/immunology , Proteins/administration & dosage , Proteins/immunology
3.
BMJ Open Qual ; 13(Suppl 2)2024 May 07.
Article in English | MEDLINE | ID: mdl-38719523

ABSTRACT

In 2017, a severe shortage of infusion bags resulted in a paradigm change in medication administration practice from intermittent infusion to intravenous push. The Institute for Safe Medication Practices proposed safe practice guidelines for adult intravenous push medications. A different study showed that ready-to-administer medication prepared in the sterile area of a pharmacy reduces the risk of harm, nurses' time for medication administration and the cost of medications. Based on the recommendation of the Institute for Safe Medication Practices, we decided to conduct a pilot study on the implementation of sterile compounding and administration of intravenous push medication in adult patients admitted to the hospital. In the study, the stability of five intravenous push antibiotic syringes was also determined in the syringes.


Subject(s)
Anti-Bacterial Agents , Syringes , Tertiary Care Centers , Humans , Syringes/standards , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/therapeutic use , Tertiary Care Centers/organization & administration , Tertiary Care Centers/statistics & numerical data , Pilot Projects , Adult , Administration, Intravenous/methods , Drug Stability , Infusions, Intravenous/methods , Infusions, Intravenous/instrumentation , Infusions, Intravenous/standards
4.
BMC Psychiatry ; 24(1): 341, 2024 May 07.
Article in English | MEDLINE | ID: mdl-38714931

ABSTRACT

BACKGROUND: Major depressive disorder (MDD) is the most disabling and burdensome mental disorder, negatively affecting an individual's quality of life and daily functioning. the current study was conducted with the aim of investigating the clinical effects of intravenous ketamine on symptoms of MDD and suicidal ideation. METHODS: The current randomized clinical trial was carried out on 64 patients diagnosed with treatment-resistant major depressive disorder between April and August 2022. The participants were randomly assigned to two groups: the intervention group received a dose of 0.5 mg/kg of ketamine, while the control group received normal saline. The Montgomery-Asberg Depression Scale and Beck's Suicidal Ideation Scale were utilized to assess depression and suicidal ideation, respectively. RESULTS: One hour after the administration of ketamine treatment, there was a notable and significant improvement in both depression symptoms (35.16 ± 8.13 vs. 14.90 ± 10.09) and suicidal ideation (6.74 ± 6.67 vs. 0.42 ± 1.52). Moreover, there were statistically significant differences in depression scores between the two groups at one hour, four hours, one day, three days, one week, one month, and two months after the administration of ketamine (p-value < 0.001). However, ketamine recipients frequently experienced side effects such as increased heart rate, headache, dizziness, and dissociative syndrome symptoms. CONCLUSION: The observed rapid onset of action and sustained effect demonstrate the potential of ketamine to provide relief from depressive symptoms in a shorter timeframe compared to traditional treatment approaches. These findings contribute to the growing body of evidence supporting the use of ketamine as a valuable therapeutic option for patients with treatment-resistant depression. IRCT REGISTRATION: IRCT registration number: IRCT20210806052096N1; IRCT URL: https://www.irct.ir/trial/62243 ; Ethical code: IR.ZUMS.REC.1400.150; Registration date: 2022-04-09.


Subject(s)
Antidepressive Agents , Depressive Disorder, Major , Depressive Disorder, Treatment-Resistant , Ketamine , Suicidal Ideation , Humans , Ketamine/therapeutic use , Ketamine/administration & dosage , Male , Female , Depressive Disorder, Major/drug therapy , Adult , Depressive Disorder, Treatment-Resistant/drug therapy , Antidepressive Agents/therapeutic use , Antidepressive Agents/administration & dosage , Middle Aged , Administration, Intravenous , Psychiatric Status Rating Scales , Treatment Outcome
5.
BMC Emerg Med ; 24(1): 79, 2024 May 06.
Article in English | MEDLINE | ID: mdl-38710999

ABSTRACT

BACKGROUND: This study compared out-of-hospital cardiac arrest (OHCA) patient outcomes based on intravenous (IV) access and prehospital epinephrine use. METHODS: A retrospective study in Ulsan, South Korea, from January 2017 to December 2022, analyzed adult nontraumatic OHCA cases. Patients were grouped: Group 1 (no IV attempts), Group 2 (failed IV access), Group 3 (successful IV access without epinephrine), and Group 4 (successful IV access with epinephrine), with comparisons using logistic regression analysis. RESULTS: Among 2,656 patients, Group 4 had significantly lower survival to hospital discharge (adjusted OR 0.520, 95% CI 0.346-0.782, p = 0.002) and favorable neurological outcomes (adjusted OR 0.292, 95% CI 0.140-0.611, p = 0.001) than Group 1. Groups 2 and 3 showed insignificant survival to hospital discharge (adjusted OR 0.814, 95% CI 0.566-1.171, p = 0.268) and (adjusted OR 1.069, 95% CI 0.810-1.412, p = 0.636) and favorable neurological outcomes (adjusted OR 0.585, 95% CI 0.299-1.144, p = 0.117) and (adjusted OR 1.075, 95% CI 0.689-1.677, p = 0.751). In the shockable rhythm group, Group 3 had better survival to hospital discharge (adjusted OR 1.700, 95% CI 1.044-2.770, p = 0.033). CONCLUSIONS: Successful IV access with epinephrine showed worse outcomes in both rhythm groups than no IV attempts. Outcomes for failed IV and successful IV access without epinephrine were inconclusive. Importantly, successful IV access without epinephrine showed favorable survival to hospital discharge in the shockable rhythm group, warranting further research into IV access for fluid resuscitation in shockable rhythm OHCA patients.


Subject(s)
Emergency Medical Services , Epinephrine , Out-of-Hospital Cardiac Arrest , Humans , Out-of-Hospital Cardiac Arrest/mortality , Out-of-Hospital Cardiac Arrest/drug therapy , Out-of-Hospital Cardiac Arrest/therapy , Epinephrine/administration & dosage , Male , Female , Retrospective Studies , Republic of Korea , Middle Aged , Aged , Cardiopulmonary Resuscitation , Adult , Administration, Intravenous
7.
Sci Rep ; 14(1): 10997, 2024 05 14.
Article in English | MEDLINE | ID: mdl-38744855

ABSTRACT

Intravenous application of tranexamic acid (TXA) in posterior lumbar interbody fusion (PLIF) can effectively reduce blood loss without affecting coagulation function. However, it has not been reported whether preoperative use of anticoagulants may affect the efficacy of TXA in PLIF. The purpose of this study is to observe the effect of preoperative use of anticoagulants on coagulation indicators and blood loss after PLIF receiving intravenous unit dose TXA. A retrospective analysis was conducted on data from 53 patients with PLIF between 2020.11 and 2022.9, who received intravenous application of a unit dose of TXA (1 g/100 mL) 15 min before the skin incision after general anesthesia. Those who used anticoagulants within one week before surgery were recorded as the observation group, while those who did not use anticoagulants were recorded as the control group. The main observation indicators include surgical time, intraoperative blood loss, postoperative drainage volume, blood transfusion, and red blood cell (RBC), hemoglobin (HB), and hematocrit (HCT) measured on the 1st, 4th, 7th, and last-test postoperative days. Secondary observation indicators included postoperative incision healing, deep vein thrombosis of lower limbs, postoperative hospital stay, and activated partial thrombin time (APTT), prothrombin time (PT), thrombin time (TT), fibrinogen (FIB), and platelets (PLT) on the 1st and 4th days after surgery. The operation was successfully completed in both groups, the incision healed well after operation, and no lower limb deep vein thrombosis occurred. There was no significant difference in surgical time, intraoperative blood loss, postoperative drainage volume, and blood transfusion between the two groups (p > 0.05). There was no significant difference in the RBC, HB, and HCT measured on the 1st, 4th, 7th, and last-test postoperative days between the two groups (p > 0.05). There was no statistically significant difference in APTT, PT, TT, FIB and PLT between the two groups on the 1st and 4th postoperative days (p > 0.05). There was no significant difference in postoperative hospital stay between the two groups (p > 0.05). The use of anticoagulants within one week before surgery does not affect the hemostatic effect of intravenous unit dose TXA in PLIF.


Subject(s)
Anticoagulants , Blood Loss, Surgical , Tranexamic Acid , Humans , Tranexamic Acid/administration & dosage , Tranexamic Acid/therapeutic use , Female , Male , Middle Aged , Retrospective Studies , Case-Control Studies , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Anticoagulants/pharmacology , Blood Loss, Surgical/prevention & control , Aged , Administration, Intravenous , Spinal Fusion/methods , Preoperative Care/methods , Antifibrinolytic Agents/administration & dosage , Antifibrinolytic Agents/therapeutic use , Blood Coagulation/drug effects
8.
J Coll Physicians Surg Pak ; 34(5): 509-513, 2024 May.
Article in English | MEDLINE | ID: mdl-38720207

ABSTRACT

OBJECTIVE: To investigate the role of single dose of dexmedetomidine (0.5 mcg/kg) in reducing the incidence and severity of postoperative emergence delirium (EmD). STUDY DESIGN: A randomised controlled trial. Place and Duration of the Study: Department of Anaesthesia, Security Forces Hospital, Riyadh, Saudi Arabia, from 1st December 2022 to 30th March 2023. METHODOLOGY: Patients, aged between 18-65 years, with ASA 1-3 scheduled to undergo nasal surgeries under general anaesthesia, were inducted in the study. Exclusion criteria were patient refusal, later request for removal from the study, inability to give consent, known allergy to dexmedetomidine, body mass index (BMI) more than 35, history of obstructive sleep apnoea, history of psychiatric illness, pregnancy, and presence of liver and renal diseases. The primary outcome measure of the study was the incidence of emergence delirium in the postoperative period. RESULTS: The frequency of EmD after nasal surgery was 52.38% in the control group compared to 14.28% in the dexmedetomidine group (p = 0.01). Pain scores were not statistically different between the two groups. The duration of post anaesthesia care unit (PACU) stay was significantly lesser in dexmedetomidine group (p <0.001). The satisfaction score on the visual analogue scale (VAS) was also found to be higher in patients who received intravenous dexmedetomidine (p <0.001). CONCLUSION: The use of single dose dexmedetomidine before extubation in nasal surgeries reduces the EmD and improves patient satisfaction. KEY WORDS: Dexmedetomidine, Emergence delirium, Nasal surgery, Opioid consumption, Pain control.


Subject(s)
Airway Extubation , Dexmedetomidine , Emergence Delirium , Nasal Surgical Procedures , Humans , Dexmedetomidine/administration & dosage , Dexmedetomidine/therapeutic use , Female , Male , Adult , Emergence Delirium/prevention & control , Emergence Delirium/epidemiology , Middle Aged , Nasal Surgical Procedures/adverse effects , Young Adult , Anesthesia, General , Adolescent , Aged , Hypnotics and Sedatives/administration & dosage , Saudi Arabia , Anesthesia Recovery Period , Administration, Intravenous , Incidence
10.
J Cardiothorac Surg ; 19(1): 274, 2024 May 03.
Article in English | MEDLINE | ID: mdl-38702789

ABSTRACT

BACKGROUND: To evaluate the clinical efficacy and safety of intraoperative intravenous amiodarone for arrhythmia prevention in on-pump coronary artery bypass grafting (CABG) patients. METHODS: A meta-analysis of randomized controlled trials was conducted. Pubmed, Embase, Cochrane Library, Ovid, China National Knowledge Infrastructure, and the Wan Fang database until July 1th, 2023. The primary outcomes of interest included the incidences of intra- and post-operative atrial fibrillation (POAF), ventricular fibrillation, or any arrhythmia, including atrial fibrillation, ventricular fibrillation, ventricular tachycardia, premature ventricular contraction, and sinus bradycardia. For continuous and dichotomous variables, treatment effects were calculated as the weighted mean difference (WMD)/risk ratio (RR) and 95% confidence interval (CI). RESULTS: A database search yielded 7 randomized controlled trials including 608 patients, where three studies, including three treatments (amiodarone, lidocaine, and saline), contributed to the clinical outcome of atrial fibrillation, ventricular fibrillation, or any arrhythmia. Meta-analysis demonstrated that amiodarone can significantly reduce the incidence of POAF (RR, 0.39; 95%CI: 0.20, 0.77; P = 0.007, I2 = 0%) in patients undergoing on-pump CABG; there was no statistically significant influence on intra-operative atrial fibrillation, intra- and post-operative ventricular fibrillation, or any arrhythmia. CONCLUSIONS: The current study suggests that intraoperative administration of intravenous amiodarone may be safe and effective in preventing POAF in patients undergoing on-pump CABG. More well-designed clinical trials are needed to validate this result.


Subject(s)
Amiodarone , Anti-Arrhythmia Agents , Coronary Artery Bypass , Humans , Amiodarone/administration & dosage , Amiodarone/adverse effects , Coronary Artery Bypass/adverse effects , Anti-Arrhythmia Agents/administration & dosage , Anti-Arrhythmia Agents/adverse effects , Anti-Arrhythmia Agents/therapeutic use , Arrhythmias, Cardiac/prevention & control , Intraoperative Care/methods , Administration, Intravenous , Postoperative Complications/prevention & control , Treatment Outcome , Randomized Controlled Trials as Topic
12.
Isr Med Assoc J ; 26(5): 304-308, 2024 May.
Article in English | MEDLINE | ID: mdl-38736346

ABSTRACT

BACKGROUND: Pyogenic flexor tenosynovitis (PFT) is a common and severe hand infection. Patients who present early can be treated with intravenous antibiotics. OBJECTIVES: To determine whether PFT caused by animal bites and treated with antibiotics leads to a different outcome than other disease etiologies due to the extensive soft tissue insult and different bacterial flora. METHODS: We conducted a retrospective cohort study of 43 consecutive patients who presented with PFT between 2013 and 2020. The 10 patients who presented with PFT following an animal bite were compared to those who presented with PFT caused by any other etiology. RESULTS: Patients who were bitten pursued medical attention sooner: 1.9 ± 1.4 days compared with 5.3 ± 4.7 days (P = 0.001). Despite the quicker presentation, patients from the study group received similar antibiotic types and duration as controls. All patients were initially treated with intravenous antibiotics under surveillance of a hand surgeon. One patient (10%) from the study group and four controls (12%) were treated surgically (P = 1). Average follow-up was 17 ± 16 days. At the end of follow-up, one (10%) patient from the study group and three (9%) controls sustained mild range of motion limitation and one (3%) patient from the control group had moderate limitations (P = 0.855). CONCLUSIONS: Intravenous antibiotic treatment, combined with an intensive hand surgeon follow-up, is a viable option for the treatment of PFT caused by animal bites.


Subject(s)
Anti-Bacterial Agents , Bites and Stings , Tenosynovitis , Humans , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/therapeutic use , Tenosynovitis/etiology , Tenosynovitis/drug therapy , Tenosynovitis/microbiology , Tenosynovitis/therapy , Retrospective Studies , Animals , Male , Female , Bites and Stings/complications , Bites and Stings/drug therapy , Adult , Middle Aged , Treatment Outcome , Administration, Intravenous
13.
J Am Heart Assoc ; 13(9): e033316, 2024 May 07.
Article in English | MEDLINE | ID: mdl-38639371

ABSTRACT

BACKGROUND: Despite its approval for acute ischemic stroke >25 years ago, intravenous thrombolysis (IVT) remains underused, with inequities by age, sex, race, ethnicity, and geography. Little is known about IVT rates by insurance status. METHODS AND RESULTS: We assessed temporal trends from 2002 to 2015 in IVT for acute ischemic stroke in the Nationwide Inpatient Sample using adjusted, survey-weighted logistic regression. We calculated odds ratios for IVT for each category in 2002 to 2008 (period 1) and 2009 to 2015 (period 2). IVT use for acute ischemic stroke increased from 1.0% in 2002 to 6.8% in 2015 (adjusted annual relative ratio, 1.15). Individuals aged ≥85 years had the most pronounced increase during 2002 to 2015 (adjusted annual relative ratio, 1.18) but were less likely to receive IVT compared with 18- to 44-year-olds in period 1 (adjusted odds ratio [aOR], 0.23) and period 2 (aOR, 0.36). Women were less likely than men to receive IVT, but the disparity narrowed over time (period 1: aOR, 0.81; period 2: aOR, 0.94). Inequities in IVT resolved for Hispanic individuals in period 2 (aOR, 0.96) but not for Black individuals (period 2: aOR, 0.81). The disparity in IVT for Medicare patients, compared with privately insured patients, lessened over time (period 1: aOR, 0.59; period 2: aOR, 0.75). Patients treated in rural hospitals remained less likely to receive IVT than in urban hospitals; a more dramatic increase in urbanity widened the inequity (period 2, urban nonteaching versus rural: aOR, 2.58, period 2, urban teaching versus rural: aOR, 3.90). CONCLUSIONS: IVT for acute ischemic stroke increased among adults. Despite some encouraging trends, the remaining disparities highlight the need for intensified efforts at addressing inequities.


Subject(s)
Fibrinolytic Agents , Healthcare Disparities , Ischemic Stroke , Thrombolytic Therapy , Humans , Female , United States/epidemiology , Male , Ischemic Stroke/drug therapy , Ischemic Stroke/ethnology , Ischemic Stroke/diagnosis , Aged , Middle Aged , Thrombolytic Therapy/trends , Thrombolytic Therapy/statistics & numerical data , Healthcare Disparities/trends , Healthcare Disparities/ethnology , Adult , Aged, 80 and over , Young Adult , Adolescent , Fibrinolytic Agents/therapeutic use , Fibrinolytic Agents/administration & dosage , Inpatients , Time Factors , Administration, Intravenous , Insurance Coverage/statistics & numerical data
16.
N Engl J Med ; 390(14): 1265-1276, 2024 Apr 11.
Article in English | MEDLINE | ID: mdl-38598794

ABSTRACT

BACKGROUND: Platinum-based chemotherapy is the recommended adjuvant treatment for patients with resectable, ALK-positive non-small-cell lung cancer (NSCLC). Data on the efficacy and safety of adjuvant alectinib as compared with chemotherapy in patients with resected ALK-positive NSCLC are lacking. METHODS: We conducted a global, phase 3, open-label, randomized trial in which patients with completely resected, ALK-positive NSCLC of stage IB (tumors ≥4 cm), II, or IIIA (as classified according to the seventh edition of the Cancer Staging Manual of the American Joint Committee on Cancer and Union for International Cancer Control) were randomly assigned in a 1:1 ratio to receive oral alectinib (600 mg twice daily) for 24 months or intravenous platinum-based chemotherapy in four 21-day cycles. The primary end point was disease-free survival, tested hierarchically among patients with stage II or IIIA disease and then in the intention-to-treat population. Other end points included central nervous system (CNS) disease-free survival, overall survival, and safety. RESULTS: In total, 257 patients were randomly assigned to receive alectinib (130 patients) or chemotherapy (127 patients). The percentage of patients alive and disease-free at 2 years was 93.8% in the alectinib group and 63.0% in the chemotherapy group among patients with stage II or IIIA disease (hazard ratio for disease recurrence or death, 0.24; 95% confidence interval [CI], 0.13 to 0.45; P<0.001) and 93.6% and 63.7%, respectively, in the intention-to-treat population (hazard ratio, 0.24; 95% CI, 0.13 to 0.43; P<0.001). Alectinib was associated with a clinically meaningful benefit with respect to CNS disease-free survival as compared with chemotherapy (hazard ratio for CNS disease recurrence or death, 0.22; 95% CI, 0.08 to 0.58). Data for overall survival were immature. No unexpected safety findings were observed. CONCLUSIONS: Among patients with resected ALK-positive NSCLC of stage IB, II, or IIIA, adjuvant alectinib significantly improved disease-free survival as compared with platinum-based chemotherapy. (Funded by F. Hoffmann-La Roche; ALINA ClinicalTrials.gov number, NCT03456076.).


Subject(s)
Antineoplastic Agents , Carcinoma, Non-Small-Cell Lung , Lung Neoplasms , Platinum Compounds , Humans , Carbazoles/therapeutic use , Carcinoma, Non-Small-Cell Lung/drug therapy , Carcinoma, Non-Small-Cell Lung/genetics , Carcinoma, Non-Small-Cell Lung/surgery , Lung Neoplasms/drug therapy , Lung Neoplasms/genetics , Lung Neoplasms/surgery , Neoplasm Recurrence, Local/drug therapy , Piperidines/therapeutic use , Receptor Protein-Tyrosine Kinases , Treatment Outcome , Administration, Oral , Administration, Intravenous , Platinum Compounds/therapeutic use , Antineoplastic Agents/therapeutic use
17.
Epilepsy Res ; 202: 107360, 2024 May.
Article in English | MEDLINE | ID: mdl-38652997

ABSTRACT

INTRODUCTION: Early switch-over of anti-seizure medications (ASMs) from intravenous to oral route may reduce the duration of hospitalization, drug acquisition costs, and behavioral upset in hospitalized children with seizures. OBJECTIVE: The primary objective was to compare short-term seizure recurrence within 1 week in hospitalized children aged 1 month to 18 years with new-onset/breakthrough seizures after an early versus late switch-over from intravenous to the oral route of ASMs. Secondary objectives were to compare the incidence of status epilepticus, duration of hospital stay, drug acquisition costs, and caregiver-reported satisfaction scores in both groups. METHODS: In this single-blind randomized controlled trial, patients with seizures were categorized based on the number of ASMs required and the history of status epilepticus. Patients in each category were randomized in a 1:1 ratio into either early or late switch-over (ES or LS) groups. In the ES groups, ASMs were tapered one-by-one between 0 and 24 hours of seizure freedom, while in the LS groups, they were tapered one-by-one between 24 and 48 hours of seizure freedom. RESULTS: A total of 112 children were enrolled in the study, with 56 in each arm. Seizure recurrence at 1 week and 12 weeks was comparable in ES and LS groups (3/55 vs. 1/54 at 1 week, p=0.61; 7/49 vs. 6/49 at 12 weeks, p=0.98). Drug acquisition costs were significantly lower in the ES group (393±274 vs. 658±568 INR, p=0.002). Thrombophlebitis and dysphoria were significantly more common in the LS group (p=0.008 and 0.03, respectively). CONCLUSION: The early switch-over of ASMs from intravenous to oral route is safe without any significant increased risk of short-term seizure recurrence and also associated with a reduction in the incidence of thrombophlebitis and ASM acquisition costs. TRIAL REGISTRATION NO: CTRI/2021/03/032145.


Subject(s)
Administration, Intravenous , Anticonvulsants , Seizures , Humans , Male , Female , Child , Anticonvulsants/administration & dosage , Anticonvulsants/therapeutic use , Seizures/drug therapy , Child, Preschool , Single-Blind Method , Administration, Oral , Infant , Adolescent , Treatment Outcome , Length of Stay/statistics & numerical data
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