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

Vijeta Bajpai; Tejas K Patel; Priyanka Dwivedi; Ankita Kabi; Yashpal Singh; Richa Agarwal; Ravi Gupta; Surekha Kishore

doi:10.4103/picr.picr_305_23

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

Perspect Clin Res. 2024 Oct-Dec;15(4):195-201. doi: 10.4103/picr.picr_305_23. Epub 2024 Jul 10.

Authors

Vijeta Bajpai¹, Tejas K Patel², Priyanka Dwivedi¹, Ankita Kabi¹, Yashpal Singh³, Richa Agarwal⁴, Ravi Gupta⁵, Surekha Kishore⁶

Affiliations

¹ Department of Anaesthesiology, All India Institute of Medical Sciences, Gorakhpur, India.
² Department of Pharmacology, All India Institute of Medical Sciences, Gorakhpur, India.
³ Department of Anaesthesiology, Banaras Hindu University, Varanasi, Uttar Pradesh, India.
⁴ Department of Ophthalmology, All India Institute of Medical Sciences, Gorakhpur, India.
⁵ Department of General Surgery, All India Institute of Medical Sciences, Gorakhpur, India.
⁶ Department of Community and Family Medicine, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India.

Abstract

Background: 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).

Materials and methods: 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.

Results: 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.

Conclusion: 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.

Keywords: Diclofenac; heparin; quick penetrating solution; quick penetrating solution diclofenac; quick penetrating solution heparin; superficial thrombophlebitis; topical heparin.