Introduction Peripheral intravenous cannulation is one of the most frequently performed procedures in hospitalized children. Despite its necessity it is often complicated by superficial thrombophlebitis leading to pain, premature catheter removal, interruption of therapy, and increased morbidity. The incidence of thrombophlebitis in pediatric populations varies between 25 to 60 percent depending on cannula size, site, dwell time, and preventive measures used. Topical heparin preparations have been studied for their role in reducing local inflammation and thrombosis. Two formulations commonly used are Heparin Quick Penetrating Solution QPS which offers enhanced absorption through the skin and Heparin Gel which has a slower transdermal penetration. While both have shown efficacy in adults, comparative studies in children are scarce. This study aims to prospectively compare the efficacy of Heparin QPS solution and Heparin gel in preventing superficial thrombophlebitis in children undergoing peripheral intravenous therapy.
Study Objectives Primary Objective To compare the efficacy of Heparin QPS solution versus Heparin gel in preventing superficial thrombophlebitis in children. Secondary Objectives To assess the time to onset of thrombophlebitis if any in both groups. To compare the severity of thrombophlebitis using a standardized scoring system. To evaluate local adverse effects of both preparations.
Study Design Study Design Prospective randomized open label parallel group study. Study Setting In patient department of Pediatrics Chettinad Hospital and Research Institute Kelambakkam Chennai 603103. Study Population Children aged 1 to 12 years requiring intravenous cannulation for more than 48 hours.
Number of Subjects or Sample Size Sample Size Based on prior studies showing an incidence difference of 20 percent in thrombophlebitis with topical heparin power 80 percent alpha 0.05 the estimated sample size is 60 patients per group total 120.
Study Methodology or Procedure Study Design Prospective randomized open label parallel group study. Study Setting In patient department of Pediatrics Chettinad Hospital and Research Institute Kelambakkam Chennai 603103. Study Population Children aged 1 to 12 years requiring intravenous cannulation for more than 48 hours. Sample Size Based on prior studies showing an incidence difference of 20 percent in thrombophlebitis with topical heparin power 80 percent alpha 0.05 the estimated sample size is 60 patients per group total 120.
Inclusion Criteria 1. Children aged 1 to 12 years. 2. Hospitalized and requiring IV cannulation for at least 48 hours. 3. Written informed consent from parents or guardians.
Exclusion Criteria 1. Known hypersensitivity to heparin or excipients. 2. Bleeding disorders or anticoagulant therapy. 3. Severe skin disease or infection at the cannulation site. 4. Critically ill children in shock requiring central lines.
Randomization Participants will be randomized into two groups using a computer generated random sequence Group A Heparin QPS solution applied topically around the cannula site every 8 hours for 72 hours or until discharge. Group B Heparin gel applied similarly every 8 hours for 72 hours or until discharge.
Blinding Open label as blinding is not feasible due to different formulations.
Study Intervention Application of allocated formulation around the cannula insertion site using aseptic precautions.
Study Outcome or End Points Primary Outcome Incidence of superficial thrombophlebitis assessed daily for 5 days or until cannula removal using the Visual Infusion Phlebitis VIP Score. Secondary Outcomes Time to onset of thrombophlebitis. Severity graded by VIP score. Local adverse events such as erythema and rash.
Expected Outcomes The study is expected to determine whether Heparin QPS solution provides superior protection against superficial thrombophlebitis compared to Heparin gel in pediatric patients. Results may guide standard protocols for thrombophlebitis prevention in children potentially reducing morbidity and healthcare costs.
Ethical Considerations This study will be conducted after getting approval from my Ethics Committee and after getting registered to the Clinical Trial Registry of India. Informed consent from parents or guardians. Assent from children where appropriate. Both preparations are already in clinical use hence minimal risk. Confidentiality of patient data will be maintained.
Study Duration Three months.
References 1. Rabbani Tappa et al Comparison of the efficacy of topical heparin quick penetrating solution and intravenous hydrocortisone in the prevention of thrombophlebitis A randomized controlled study Journal of Clinical and Scientific Research 14 1 pages 45 to 49 Jan to Mar 2025 DOI 10.4103 jcsr jcsr 223 23 2. Chauhan A P Jain M Mehta J Shah A Thomas S M 2024 A prospective randomized comparative study to evaluate the safety and efficacy of topical quick penetrating solution QPS of Heparin 1000 IU per ml versus Heparin gel 200 IU per ml in prevention of intravenous cannula related thrombophlebitis in post operative onco surgical intensive care unit ICU patients Indian Journal of Clinical Anaesthesia 11 4 448 to 452 https doi.org 10.18231 j.ijca.2024.084 3. Bajpai V Patel T K Dwivedi P et al 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 Perspectives in Clinical Research 2024 15 4 195 to 201 doi 10.4103 picr.picr 305 23 4. Dahal A S Tuitui R Shrestha P D Sharma B Acharya S and Dahal P 2020 Effectiveness of Glycerin Magnesium Sulphate Versus Heparin Benzyl Nicotinate Application Among Children with Phlebitis Journal of Nepal Paediatric Society 40 1 21 to 27 |