Efficacy and safety of quick penetrating solution heparin, quick penetrating solution diclofenac, and heparin gel in the prevention of infusion-associated superficial thrombophlebitis: A randomized controlled trial

Q2 Medicine
Vijeta Bajpai, Tejas K. Patel, Priyanka Dwivedi, Ankita Kabi, Yashpal Singh, Richa Agarwal, Ravi Gupta, Surekha Kishore
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Abstract

The present study aimed to compare the efficacy, safety, and cost-effectiveness of quick penetrating solution (QPS) heparin, QPS diclofenac, and heparin gel in the prevention of superficial thrombophlebitis (ST). This randomized controlled trial was conducted after approval from the Institutional Ethics Committee and registration to Clinical Trial Registry of India. Patients of 18–60 years age, American Society of Anesthesiologists I/II, and who needed venous cannulation for at least 72 h were included in the study. Patients were randomly divided into three groups receiving study drugs (heparin gel, QPS heparin, and QPS diclofenac) every 8 hourly for a period of 72 h. Venous cannulation site was graded using the Visual Infusion Phlebitis Scale. Patients developing no ST, mean time to reach ST Grade 1 and 2, prevention of ST probability, and cost-effectiveness of interventions during the study period were assessed. Out of 219 included patients, development of no ST in the study groups at 72 h of treatment were heparin gel (11%), QPS heparin (9.6%), and QPS diclofenac (2.7%). The mean time (hours) to develop any grade ST in the study arms was heparin gel (36.2 [11.9]), QPS heparin (40.0 [13.4]), and QPS diclofenac (37.0 [13.2]). The Kaplan–Meier analysis did not reveal significant differences for the prevention of any grade ST or severe ST in three treatment arms. The average cost-effectiveness ratio for preventing thrombophlebitis was 14.2 in heparin gel-, 13.2 in QPS heparin-, and 95.6 in QPS diclofenac-treated patients. Based on efficacy, safety, and cost-effectiveness, heparin gel or QPS heparin can be used to prevent ST due to intravenous cannulation in surgical patients. QPS diclofenac is not a cost-effective option to prevent ST.
肝素快速渗透溶液、双氯芬酸快速渗透溶液和肝素凝胶在预防输液相关性浅表血栓性静脉炎方面的有效性和安全性:随机对照试验
本研究旨在比较肝素快速渗透溶液(QPS)、肝素快速渗透溶液双氯芬酸和肝素凝胶在预防浅表血栓性静脉炎(ST)方面的疗效、安全性和成本效益。 这项随机对照试验是在获得机构伦理委员会批准并在印度临床试验登记处登记后进行的。研究对象包括年龄在 18-60 岁之间、美国麻醉医师协会 I/II 级、需要静脉插管至少 72 小时的患者。患者被随机分为三组,在 72 小时内每 8 小时接受一次研究药物(肝素凝胶、QPS 肝素和 QPS 双氯芬酸)。对研究期间未发生 ST 的患者、达到 ST 1 级和 2 级的平均时间、ST 概率的预防以及干预措施的成本效益进行了评估。 在纳入的 219 名患者中,治疗 72 小时后未出现 ST 的研究组分别为肝素凝胶组(11%)、QPS 肝素组(9.6%)和 QPS 双氯芬酸组(2.7%)。肝素凝胶(36.2 [11.9])、QPS 肝素(40.0 [13.4])和 QPS 双氯芬酸(37.0 [13.2])治疗组出现任何等级 ST 的平均时间(小时)为 36.2 [11.9],QPS 肝素(40.0 [13.4])和 QPS 双氯芬酸(37.0 [13.2])。卡普兰-梅耶分析显示,三种治疗组在预防任何等级 ST 或严重 ST 方面没有显著差异。肝素凝胶治疗患者预防血栓性静脉炎的平均成本效益比为 14.2,QPS 肝素治疗患者为 13.2,QPS 双氯芬酸治疗患者为 95.6。 根据疗效、安全性和成本效益,肝素凝胶或 QPS 肝素可用于预防手术患者因静脉插管导致的 ST。QPS 双氯芬酸不是一种具有成本效益的预防 ST 的选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Perspectives in Clinical Research
Perspectives in Clinical Research Medicine-Medicine (all)
CiteScore
2.90
自引率
0.00%
发文量
41
审稿时长
36 weeks
期刊介绍: This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
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