|Year : 2019 | Volume
| Issue : 2 | Page : 95-98
A study to evaluate the efficacy of topical quick penetrating solution of heparin in preventing thrombophlebitis
Teena Bansal, Prashant Kumar, Garima Vashisht
Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma University of Health Sciences, Rohtak, Haryana, India
|Date of Submission||26-Dec-2018|
|Date of Acceptance||23-May-2019|
|Date of Web Publication||28-Aug-2019|
Dr. Teena Bansal
19/6 J, Medical Campus, PGIMS, Rohtak - 124 001, Haryana
Source of Support: None, Conflict of Interest: None
Background and Aims: Superficial thrombophlebitis is the most common complication with intravenous cannulation which is characterized by cord-like painful veins and discoloration of skin over puncture site. The study was conducted to evaluate the efficacy of topical quick penetrating solution (QPS) of heparin to prevent superficial thrombophlebitis.
Methods: This prospective randomized study included 200 patients who were divided into two groups. In Group I (control group), cannula site was observed using Phlebitis Assessment Grading Scale at 12, 24, 48, and 72 h. In Group II (heparin group), QPS of heparin was applied 12 hourly for up to 72 h, and cannula site was examined at the same time intervals as in Group I.
Results: In Group I, at 12 h, score of 0 and 1 was observed in 96 and 4 patients, respectively, whereas all patients had a score of 0 in Group II (P = 0.044). At 24 h, the score was 0, 1, and 2 in 28, 60, and 12 patients, respectively, in Group I, whereas it was 0 and 1 in 96 and 4 patients in Group II (P = 0.001). At 48 h, the score was 1 and 2 in 36 and 64 patients in Group I, whereas it was 0 and 1 in 60 and 40 patients in Group II (P = 0.001), respectively. At 72 h, the score of 2, 3, and 4 was observed in 32, 44, and 24 patients in Group I, respectively, whereas the score of 0, 1, and 2 was observed in 36, 48, and 16 patients, respectively, in Group II (P = .001).
Conclusion: Heparin QPS when applied prophylactically significantly decreased thrombophlebitis.
Keywords: Heparin, prevention, quick penetrating solution, thrombophlebitis
|How to cite this article:|
Bansal T, Kumar P, Vashisht G. A study to evaluate the efficacy of topical quick penetrating solution of heparin in preventing thrombophlebitis. Indian Anaesth Forum 2019;20:95-8
|How to cite this URL:|
Bansal T, Kumar P, Vashisht G. A study to evaluate the efficacy of topical quick penetrating solution of heparin in preventing thrombophlebitis. Indian Anaesth Forum [serial online] 2019 [cited 2019 Nov 13];20:95-8. Available from: http://www.theiaforum.org/text.asp?2019/20/2/95/265659
| Introduction|| |
Intravenous cannulation is required in up to 70% of hospitalized patients for the administration of fluids and drugs. However, 20%–80% of patients with peripheral intravenous cannulation may develop phlebitis characterized by the acute inflammation of the internal lining of the vein by mechanical, chemical, or bacterial sources resulting in pain and tenderness along the course of the vein. Phlebitis can lead to infection or thrombus formation if left untreated.
In earlier days, elective replacement of cannula every 72 h was suggested, but it was not found to prevent thrombophlebitis. Topical heparin is widely used for the prevention and treatment of phlebitis. The topical formulation allows heparin to penetrate through the skin with no systemic absorption at clinical dose, thereby decreasing the risk of adverse bleeding effects. Earlier heparin gel was used for this purpose. At present, heparin is also available as a topical quick penetrating solution (QPS) 1000 IU/mL which contains nonaqueous and nonvolatile solvents with added permeability enhancers to increase the penetration of heparin across the skin.
There are limited studies in the literature evaluating the efficacy of heparin QPS to prevent phlebitis. The present study was conducted to evaluate the efficacy of topical QPS in the prevention of phlebitis in patients undergoing emergency surgery requiring postoperative intravenous cannulation for 72 h.
| Methods|| |
The present prospective randomized study was conducted after local Institutional Research and Ethical Committee approval and written consent. A total of 200 adult patients between 18 and 60 years of age with the American Society of Anesthesiologists Status I or II scheduled for emergency surgery under general anesthesia requiring intravenous cannula for >72 h were included in the study.
Patients with known hypersensitivity to heparin, coagulation disorders, sepsis, deep-vein thrombosis, carcinoma, diabetes mellitus, and contraindication to heparin were excluded from the study. In addition, patients on anticoagulants, pregnant and lactating patients, and those not willing to participate in the study were also excluded. The lateral side of the wrist was cleaned with spirit swab, and peripheral vein (cephalic vein) was cannulated using 18G cannula taking aseptic precautions.
It was an open-label study. The patients were randomly allocated to Group I (control group) and Group II (heparin QPS group) using a computer-generated sequence of random numbers. In Group I, the cannula was secured with micropore, and this time was taken as 0 h. The cannula site was observed using Phlebitis Assessment Grading Scale at 12, 24, 48, and 72 h. In Group II, 10 drops of topical heparin 1000 IU/ml were applied along the length of the cannula before securing the cannula and the site was covered with micropore. This time was taken as 0 h. Thereafter, every 12 hourly, 10 drops of heparin were applied, and the site was covered with micropore. Patients were advised to avoid hand washing.
Demographic data consisting of age, sex, and weight were recorded. The cannula site was examined using Phlebitis Assessment Grading Scale at 12, 24, 48, and 72 h. In addition, the postoperative infusions (type of solution, drug, and antibiotics) were also recorded. The patients were assessed as per Phlebitis Assessment Grading Scale [Table 1].
By using n Master 2.0 version software at 50% proportion and 7% precision using 95% confidence intervals, the required sample size was 196. The present study included 200 patients. The data were analyzed using Statistical Package for Social Sciences (SPSS) version 20.0 (SPSS 20, IBM, Armonk, NY, United States of America). For continuous variables, the Student's t-test was applied, and for categorical data, the Mann–Whitney test was used. P < 0.05 was considered as statistically significant.
| Results|| |
The mean age of patients in Group I was 41.28 ± 13.70 years and in Group II was 38.88 ± 13.41 years, which was comparable. Similarly, weight and sex were comparable between the two groups. The mean weight of patients in Group I was 62.56 ± 9.69 kg and in Group II was 62.44 ± 10.70 kg [Table 2]. [Figure 1] shows the consort diagram.
In Group I, at 12 h, score of 0 and 1 was observed in 96 patients and 4 patients, respectively, whereas, all the 100 patients had the score of 0 in Group II (P = 0.044) [Table 3]. At 24 h, the score of 0, 1, and 2 was observed in 28, 60, and 12 patients, respectively, in Group I, whereas the score of 0 and 1 was observed in 96 and 4 patients, respectively, in Group II (P = 0.001). At 48 h, the score of 1 and 2 was observed in 36 and 64 patients, respectively, in Group I, whereas score of 0 and 1 was observed in 60 and 40 patients, respectively, in Group II (P = 0.001). At 72 h, score of 2, 3, and 4 was observed in 32, 44, and 24 patients, respectively, in Group I, whereas score of 0, 1, and 2 was observed in 36, 48, and 16 patients, respectively, in Group II (P =.001). In Group I, score up to 4 was observed, whereas maximum score was 2 in Group II and that too at 72 h in only 16 patients which proves the efficacy of topical QPS of heparin [Table 3]. The postoperative infusions were largely the same in both the groups, including Ringer's lactate, paracetamol, and cephalosporin. However, in four patients in Group I and three patients in Group II, aminoglycoside was administered.
| Discussion|| |
The results of the present study are in agreement with a study which evaluated the efficacy of QPS heparin in preventing the incidence of thrombophlebitis after peripheral intravenous cannulation. The study included 140 patients of the age group 14–55 years posted for surgery (70 patients in each group heparin and control). The authors observed significantly lesser phlebitis score in heparin group as compared to the control group. The results of the present study are also in agreement with another study in which heparin QPS was found to be more effective in treatment of early, medium, and advance thrombophlebitis due to increased penetration of heparin QPS across the skin. This study compared the efficacy of topical QPS heparin (1000 IU/ml) versus heparin gel (200 IU/g) in the management of developed thrombophlebitis in 202 patients of early, medium, and advance stage of thrombophlebitis. Change in the length of the venous lesion from baseline and proportion of patients with complete healing was recorded, and it was observed that 90% of patients in heparin QPS group got healed as compared to 65.7% patients in the heparin gel group. In the present study, heparin was used prophylactically while these authors used heparin QPS for the management of phlebitis.
Superficial thrombophlebitis is a serious consequence in response to cannula itself or injected drugs. The basic mechanism responsible is a foreign body reaction due to indwelling cannula or the injected drugs resulting in inflammation and formation of clot. The predominant action of heparin occurs by inhibiting coagulation and with a very little effect on preformed clots. Hence, topical heparin if started after the development of thrombophlebitis has a poor efficacy which is approximately 44.3%. Prophylactic heparin can effectively prevent clot formation and decrease the incidence of thrombophlebitis.
Various factors responsible for thrombophlebitis include age, sex, weight, irritant drugs along with site, size, and duration of cannulation. In addition, patients with sepsis, carcinoma, diabetes mellitus, and chemotherapy are also at higher risk. In the present study, both the groups were comparable regarding age, sex, weight, drugs, site, size, and duration of cannulation.
In the control group, when the site was observed at 48 h, maximum score was 2. Phlebitis Assessment Grading Scale recommends resite of the cannula at score of ≥2. We resited the cannula and started the infusions through the new cannula. However, we did not remove the initial cannula for the study purpose. Further, we did not expect the score to be 3 and 4 at 72 h. However, when we observed the site at 72 h, the score was 3 or 4. Phlebitis Assessment Grading Scale recommends treatment at score of ≥3. We removed the cannula at 72 h and started applying heparin QPS 12 hourly at the site. The lesions healed in 5–7 days in all the patients, proving the efficacy of heparin QPS. Ideally, we should have removed the cannula at score of 2, which is a drawback of the present study.
| Conclusion|| |
The present study suggests that the application of QPS solution prophylactically significantly decreased the incidence of thrombophlebitis. It may be of particular importance in high-risk groups and in patients who require intravenous cannulation for the increased duration.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Yambem M, Madhale M, Bagi D. A comparative study to assess effectiveness of glycerine with magnesium sulphate versus heparin-benzyl nicotinate (Thromophob) ointment on management of thrombophlebitis among patients admitted in intensive care units (ICU) of selected hospital in Belgaum, Karnataka. Int J Sci Res 2015;4:1458-61.
Beigh OA, Rahaman H. Efficacy of topical heparin in preventing the incidence of thrombophlebitis after peripheral intra venous cannulation. IOSR J Dent Med Sci 2016;15:50-4.
Yaribeygi H, Hosseini MJ, Rokhsarizadeh H, Meftahi GH, Salesi M. Routine offered protocol is not reliable for thrombophlebitis prevention. Hosp Pract Res 2016;1:43-6.
Kalodiki E, Nicolaides AN. Superficial thrombophlebitis and low-molecular-weight heparins. Angiology 2002;53:659-63.
Priya JJ, Missiriya MA. Selected intervention strategy on thrombophlebitis among patients with intravenous cannula. Int J Hum Arts Med Sci 2015;3:31-6.
Supe A, Subnis BM, Rao MR, Panchal VH, Lakhani RJ, Methalia B, et al
. Novel topical quick penetrating solution of heparin in management of superficial thrombophlebitis: Results of randomized active controlled trial. Int J Pharm Sci Res 2013;4:4442-7.
Cesarone MR, Belcaro G, Agus G, Georgiev M, Errichi BM, Marinucci R, et al.
Management of superficial vein thrombosis and thrombophlebitis: Status and expert opinion document. Angiology 2007;58 Suppl 1:7S-14S.
Cesarone MR, Belcaro G, Corsi M, Ippolito E, Errichi S, Di Renzo A, et al.
Local heparin, superficial vein thrombosis. Angiology 2007;58 Suppl 1:36S-40S.
Villardell M, Sabat D, Arnaiz JA, Bleda MJ, Castel JM, Laporte JR, et al
. Topical heparin for the treatment of acute superficial phlebitis secondary to indwelling intravenous catheter. A double -blind randomised, placebo-controlled trial. Eur J Clin Pharmacol 1999;54:917-21.
Arun Babu T, Sharmila V. Prophylactic topical heparin can prevent or postpone intravenous cannula induced superficial thrombophlebitis. Med Hypotheses 2010;74:857-8.
Uslusoy E, Mete S. Predisposing factors to phlebitis in patients with peripheral intravenous catheters: a descriptive study. J Am Acad Nurse Pract 2008; 20: 172-80.
[Table 1], [Table 2], [Table 3]