• Title/Summary/Keyword: Adverse drug events

Search Result 196, Processing Time 0.028 seconds

A Survey on Procedural Sedation and Analgesia for Pediatric Facial Laceration Repair in Korea

  • Dongkyu Lee;Hyeonjung Yeo;Yunjae Lee;Hyochun Park;Hannara Park
    • Archives of Plastic Surgery
    • /
    • v.50 no.1
    • /
    • pp.30-36
    • /
    • 2023
  • Background Most children with facial lacerations require sedation for primary sutures. However, sedation guidelines for invasive treatment are lacking. This study evaluated the current status of the sedation methods used for pediatric facial laceration repair in Korea. Methods We surveyed one resident in each included plastic surgery training hospital using face-to-face interviews or e-mail correspondence. The health care center types (secondary or tertiary hospitals), sedation drug types, usage, and dosage, procedure sequence, monitoring methods, drug effects, adverse events, and operator and guardian satisfaction were investigated. Results We included 45/67 hospitals (67%) that used a single drug, ketamine in 31 hospitals and chloral hydrate in 14 hospitals. All health care center used similar sedatives. The most used drug administered was 5 mg/kg intramuscular ketamine (10 hospitals; 32%). The most common chloral hydrate administration approach was oral 50 mg/kg (seven hospitals; 50%). Twenty-two hospitals (71%) using ketamine followed this sequence: administration of sedatives, local anesthesia, primary repair, and imaging work-up. The most common sequence used for chloral hydrate (eight hospitals; 57%) was local anesthesia, administration of sedatives, imaging work-up, and primary repair. All hospitals that used ketamine and seven (50%) of those using chloral hydrate monitored oxygen saturation. Median operator satisfaction differed significantly between ketamine and chloral hydrate (4.0 [interquartile range, 4.0-4.0] vs. 3.0 [interquartile range, 3.0-4.0]; p <0.001). Conclusion The hospitals used various procedural sedation methods for children with facial lacerations. Guidelines that consider the patient's condition and drug characteristics are needed for safe and effective sedation.

Flumazenil administration in suspected patients with acute hypnotics and sedatives poisoning: risk-benefit re-evaluation (급성 진정제 중독 추정 환자에서 플루마제닐의 투여: 위험도/이익 재평가)

  • Huh, Jae Hong;Choi, Sang Chun;Lim, Yong Gyun;Lampotang, Samsun;Park, Eung Jung
    • Journal of The Korean Society of Clinical Toxicology
    • /
    • v.14 no.2
    • /
    • pp.92-99
    • /
    • 2016
  • Purpose: The use of flumazenil administration in the emergency department is still controversial because of concerns about adverse effects. The present study was conducted to re-evaluate the risk-benefit ratio associated with flumazenil administration to patients suspected of having acute hypnotics and sedatives poisoning in the emergency department. Methods: A retrospective chart review study was conducted for patients whose final diagnoses were "poisoning" and "benzodiazepine" or "sedatives-hypnotics" from Mar. 2006 to Feb. 2015. The basal characteristics of the patients, including past medical history, ingredients and dose of ingested drug and co-ingested drugs were investigated. For patients administered flumazenil, responsiveness and time from admission to flumazenil administration were investigated with supplement. All collected data were analyzed in aspect terms of risk/benefit. Results: A total of 678 patients were included in our study. Benzodiazepine was the most common sedative/hypnotic drug prescribed, and the frequency of prescription continuously increased. The proportion of TCA as co-ingestion decreased from 13.1% to 3.9% in patients with acute sedative/hypnotic poisoning. Flumazenil was administered to 55 patients (8.1%), of which 29 patients (52.7%) were applied to contraindications. Fifty-three patients (96.4%) showed positive responsiveness, including partial responsiveness after flumazenil administration. No severe adverse events were identified. Conclusion: Based on the current trends in prescription patterns for sedative/hypnotic drugs, increased use of non-TCA antidepressants, and responsiveness to administration of flumazenil, benefit seemed weighted more in this study, although the observed benefits were based on limited results. Further prospective multicenter studies will be needed to optimize benefit-risk ratio.

Concurrent Use of Nefopam vs. Ketorolac with Opioid Analgesic for Post-operative Pain Management (수술 후 통증조절 목적으로 펜타닐과 병용되는 네포팜 vs. 케토롤락의 사용현황)

  • Kim, Yoon Hee;Kim, Young Won;Choi, Kyung Suk;Lee, Jung Hwa;Lee, Eunsook;Kim, Seungyeon;Choi, YoungRok;Lee, Euni
    • Korean Journal of Clinical Pharmacy
    • /
    • v.28 no.4
    • /
    • pp.279-284
    • /
    • 2018
  • Objective: To compare the analgesic effects and adverse drug reactions (ADRs) of fentanyl intravenous patient-controlled analgesia (ivPCA) with nefopam, a centrally acting analgesic agent with demonstrated opioid sparing activity, as compared to ketorolac in a tertiary teaching hospital. Methods: A retrospective evaluation of electronic medical records was conducted on patient records including either nefopam or ketorolac with opioid ivPCA for post-operative pain management in general surgery department from January to December 2014. The status of pain control and ADRs were collected. Results: Out of 6,330 general surgery cases, nefopam was given in 153 prescriptions (6.9%) and ketorolac in 81 prescriptions (3.6%). The level of pain control was not different between two groups (70.9% vs. 75.3%; p = 0.51), but ADRs were more frequently reported in nefopam group (9.8% vs. 2.5%; p < 0.05). New ADRs of hot flushes (n = 1) and paresthesia in hands (n = 1) were reported in nefopam group and they were unlisted in the approved package insert. No serious ADRs were reported in both groups. Conclusion: Our findings presented that nefopam showed a similar analgesic effect and higher ADR rates compared to ketorolac as an adjuvant to fentanyl iv PCA for post-operative pain management in general surgery patients in South Korea.

Risk Factors of Potentially Inappropriate Medications and Cost by Polypharmacy among Elderly Patients of a Community Pharmacy near a Top Tier General Hospital (상급종합병원 근처의 한 지역약국 처방전 분석에 의한 노인 환자의 다약제복용과 약제비용 및 잠재적으로 부적절한 약물사용 관련 위험인자)

  • Kim, Aram;Kim, Hong Ah;Rhie, Sandy Jeong
    • Korean Journal of Clinical Pharmacy
    • /
    • v.25 no.3
    • /
    • pp.159-165
    • /
    • 2015
  • Objective: Polypharmacy is one of the main causes of inappropriate medication use, adverse drug-related events and cost. It aimed to investigate the status of polypharmacy and potentially inappropriate medication (PIM), the factors affecting polypharmacy and cost in elderly outpatients. Method: A pharmacy claim data were retrospectively analyzed with elderly patients prescriptions at a pharmacy located near a top tier general hospital. The numbers of medications per person, prevalence of polypharmacy and PIM according to the 2012 Beers criteria and Korea PIM list, medication cost and the factors affecting polypharmacy were investigated. Results: Forty-six percentages of the elderly outpatients received polypharmacy and over 21% of them had medications listed in Beers or Korean PIM. In multiregressional analysis, we found that age, gender and insurance types were affective factors of polypharmacy. (p < 0.001, 0.047, 0.009, respectively). The cost of polypharmacy with PIM in elderly outpatients was increased with age. Various approaches of interventions would be further required.

Benefits and risks of therapeutic alternatives for macrolide resistant Mycoplasma pneumoniae pneumonia in children

  • Yang, Hyeon-Jong
    • Clinical and Experimental Pediatrics
    • /
    • v.62 no.6
    • /
    • pp.199-205
    • /
    • 2019
  • Although Mycoplasma pneumoniae pneumonia (MPP) has been generally susceptible to macrolides, the emergence of macrolide-resistant MPP (MRMP) has made its treatment challenging. MRMP rapidly spread after the 2000s, especially in East Asia. MRMP is more common in children and adolescents than in adults, which is likely related to the frequent use of macrolides for treating M. pneumoniae infections in children. MRMP is unlikely to be related to clinical, laboratory, or radiological severity, although it likely prolongs the persistence of symptoms and the length of hospital stay. Thereby, it causes an increased burden of the disease and poor quality of life for the patient as well as a societal socioeconomic burden. To date, the only alternative treatments for MRMP are secondary antimicrobials such as tetracyclines (TCs) or fluoroquinolones (FQs) or systemic corticosteroids; however, the former are contraindicated in children because of concerns about potential adverse events (i.e., tooth discoloration or tendinopathy). A few guidelines recommended TCs or FQs as the second-line drug of choice for treating MRMP. However, there have been no evidence-based guidelines. Furthermore, safety issues have not yet been resolved. Therefore, this article aimed to review the benefits and risks of therapeutic alternatives for treating MRMP in children and review the recommendations of international or regional guidelines and specific considerations for their practical application.

Adverse Effects of Chloral Hydrate in Neonates: Frequency and Related Factors (신생아에서 Chloral Hydrate의 부작용의 빈도와 관련 인자)

  • Lee, Ju-Young;Youn, Young-Ah;Kim, Soon-Ju;Lee, Hyun-Seung;Kim, So- Young;Sung, In-Kyung;Chun, Chung-Sik
    • Neonatal Medicine
    • /
    • v.18 no.1
    • /
    • pp.130-136
    • /
    • 2011
  • Purpose: Chloral hydrate is a common drug frequently used for procedural sedation. But data on chloral hydrate use in the newborns are limited. This study examined the frequency of adverse effects of chloral hydrate and factors related to the adverse effects. We also examined if there were additional adverse effects when an additional sedative was used. Methods: The medical records of 104 patients admitted to neonatal intensive care unit of Seoul St. Mary's Hospital from March 2010 to February 2011 who used chloral hydrate for procedural sedation were retrospectively reviewed. Results: Adverse effects after administration of chloral hydrate were noted in 41.3% of the 104 patients. The adverse events included oxygen desaturation (18.8%), increase in apneic episodes (17.5%), increase in bradycardia (10%), and feeding intolerance (3.8%). Using oxygen at the time of chloral hydrate administration was independently associated with adverse effects (odds ratio [OR], 10.911: 95% confidence interval [CI], 2.082-57.178) and with the necessity for an additional sedative after administration of chloral hydrate (OR, 4.151: 95% CI, 1.455-11.840). Using one additional sedative agent after chloral hydrate showed no difference in adverse effects except feeding intolerance. Conclusion: Patients dependent on oxygen at the time of chloral hydrate administration may were found to be at higher risk for adverse effect of chloral hydrate and for an additional sedative. When an additional sedative is needed, it could be used with monitoring feeding intolerance after chloral hydrate administration.

Lumbosacral polyradiculoneuropathy associated with combination therapy of nivolumab and ipilimumab

  • Cho, Eun Bin;Kim, Seung Joo;Yang, Tae-Won;Jung, Seunguk;Jeong, Heejeong;Park, Ki-Jong
    • Annals of Clinical Neurophysiology
    • /
    • v.24 no.1
    • /
    • pp.26-29
    • /
    • 2022
  • Immune checkpoint inhibitors (ICIs) have emerged as one of the most promising therapeutic options for advanced cancers. While ICIs have improved survival in multiple cancers, their increased use is restricted by various immune-related adverse events. In this report we describe a patient with renal cell carcinoma who received a combination of ICIs, nivolumab plus ipilimumab, and who developed lumbosacral polyradiculoneuropathy. Corticosteroid use was an effective treatment for this patient.

Sugammadex-induced bronchospasm: a case report

  • Saeyoung Kim;Hyojun Choo;Hoon Jung;Ji Hyun Kim
    • Journal of Dental Anesthesia and Pain Medicine
    • /
    • v.23 no.5
    • /
    • pp.287-291
    • /
    • 2023
  • Sugammadex has shown faster reversal of steroidal neuromuscular blockade (NMB) than neostigmine, a traditional reversal agent for NMB, even in the intense block phase. This efficiency is possible because of the unique mechanism of action by encapsulating the NMB molecules. Therefore, with the use of sugammadex, we can also expect to avoid direct interactions with the cholinergic system and its subsequent side effects, which are disadvantages of traditional drugs. However, despite these benefits and US Food and Drug Administration (FDA) approval in 2015, rare adverse events associated with sugammadex have been reported. Herein, we report a case of bronchospasm that developed immediately after sugammadex administration.

Clinical Outcomes of Antiplatelets Combined with Statins in Patients with Ischemic Heart Disease (허혈성 심장질환 환자에서 스타틴과 병용하는 항혈소판제 종류에 따른 임상결과)

  • Kim, Chungsoo;Lee, Jimin;Park, Rae Woong;Lee, Sukhyang
    • Korean Journal of Clinical Pharmacy
    • /
    • v.29 no.4
    • /
    • pp.254-266
    • /
    • 2019
  • Background: Patients with cardiovascular risks are recommended to use statins and antiplatelet agents to prevent major cerebro-cardiovascular events (MACCE). Antiplatelet agents also possess anti-inflammatory and antioxidant effects, in addition to their inhibitory activity on platelets. The differences in clinical outcomes in ischemic heart disease (IHD) based on the type of antiplatelet therapy combined with statin treatment were investigated in this study. Methods: We conducted a retrospective cohort study using electronic medical records of IHD patients from January 2010 to December 2014 at Ajou University Hospital. Patients on combination therapy of antiplatelet drugs and statins were grouped based on antiplatelet drug types: clopidogrel, cilostazol, or sarpogrelate. Propensity score matching was applied to balance the baseline of the groups of clopidogrel vs. cilostazol and the groups of clopidogrel vs. sarpogrelate. The incidence and risk of MACCE as primary outcomes were assessed between the groups of antiplatelet drugs. Results: Among the approximately 128,500 patients with IHD, 1,049 patients had taken a combination therapy of statin and antiplatelet agents. The cohorts of patients administered clopidogrel, cilostazol, or sarpogrelate were 906, 79, and 64, respectively. The incidence of MACCE was not significantly different among the cohorts (p=0.58), and there were no differences between clopidogrel vs. cilostazol (p=0.72) or clopidogrel vs. sarpogrelate (p=1.00) after propensity score matching. Conclusion: There was no difference in the incidence of MACCE based on the type of antiplatelet drug (clopidogrel, cilostazol, or sarpogrelate) in combination with a statin in patients with IHD.

Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study (궁하탕정의 단회 경구투여 후 안전성 평가를 위한 단일기관 연구)

  • An, Sung-Hu;Shin, Hee-Ra;Park, Kyungtae;Lee, Yoon-Seung;Kim, Jonggyu;Yeom, Seung-Ryong;Kwon, Young-Dal;Cho, Hea-Young
    • Journal of Korean Medicine Rehabilitation
    • /
    • v.29 no.4
    • /
    • pp.101-108
    • /
    • 2019
  • Objectives The purpose of this study is to evaluate the safety of Gunghatang tablet in healthy male volunteers. Methods Single center pharmacokinetics study was carried out in healthy male volunteers. Through the laboratory test, vital sign and adverse event data, safety evaluation was conducted. Total 15 of 16 subjects who met the inclusion criteria were enrolled and three subjects were allocated to waiting group. 12 subjects were allocated by serial number according to registration order. Subjects took the maximum daily dose of the tablet on the second day of hospitalization. For the evaluation of safety, blood samples were collected and vital sign were checked 4 times (screening, before administration, after administration and follow up period) during the trial. All adverse events were recorded and summarized as frequency and percentage. All continuous data were summarized as mean and standard deviation. For comparison of variables between before administration and after administration, data were analyzed by paired T-test or Wilcoxon signed rank test (p<0.05). Results As a result of all data related to vital sign and laboratory test in both group, there were no significant differences associated with the clinical trial drug between pre and post administration. And there was no adverse event associated with the clinical trial drug. Conclusions Gunghatang tablet were found to be safe for healthy male volunteers.