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Randomized Controlled Trial
. 2018 Nov-Dec;50(6):344-349.
doi: 10.4103/ijp.IJP_201_17.

A prospective randomized study to evaluate safety and efficacy of heparin topical solution (1000 IU/ml) compared to heparin topical gel (200 IU/g) in prevention of infusion-associated phlebitis

Vikas Saini  1 , Tanvir Samra  1 , Nitin Ahuja  1 , Sameer Sethi  1
Affiliations
Randomized Controlled Trial

A prospective randomized study to evaluate safety and efficacy of heparin topical solution (1000 IU/ml) compared to heparin topical gel (200 IU/g) in prevention of infusion-associated phlebitis

Vikas Saini et al. Indian J Pharmacol. 2018 Nov-Dec.

Abstract

Objectives: Thrombosis and thrombophlebitis of the superficial venous system are common in hospitalized patients. Efficacy and safety of topical quick penetrating solution (QPS) of heparin were compared to heparin sodium topical gel for the prevention of infusion-associated phlebitis.

Materials and methods: Patients aged 18-65 years undergoing intravenous cannulation for at least 72 h were enrolled and randomized to receive 6-8 drops of topical solution of heparin (Group sodium topical solution [QPS]) or1 g of topical gel (Group GEL) over the cannulated vein every 8 hourly for a total of 10 doses. Enrolled patients were monitored every 8 ± 1 h for phlebitis using visual infusion phlebitis scale. The primary aim was to compare the proportion of patients with Grade 0, I, and II phlebitis at the end of 72 h of treatment period.

Results: Number of patients assessed for eligibility was 110; 26 excluded and 84 randomized. Analysis was done for 41 administered heparin QPS and 33 administered heparin gel as the rest were lost to follow-up. No phlebitis was reported in 32% of patients in QPS group and 9% in GEL group (P =0.0019). Proportion of patients with Grade I and Grade II phlebitis was 22.9% and 13.5% with QPS and 35.13% and 22.97% with gel, respectively, and the difference was statistically significant. Mean time to develop Grade I (Group QPS = 59.7 h; Group GEL = 58.46 h; P = 0.949) and Grade II (Group QPS = 62.4 h; Group GEL = 61.17 h; P = 0.732) phlebitis was comparable no adverse effects were reported in either group.

Conclusion: Heparin QPS was more effective in he prevention of infusion-associated phlebitis with similar safety profile as heparin gel.

Keywords: Heparin; quick penetrating topical solution; superficial thrombophlebitis.

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Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
CONSORT diagram
Figure 2
Figure 2
Grade III phlebitis in a patient with prophylactic topical application of heparin gel
Figure 3
Figure 3
Grade II phlebitis in a patient with prophylactic topical application of heparin quick penetrating solution
See this image and copyright information in PMC

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