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

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.