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A clinical trial to study the effects of three drugs, Topical Heparin, QPS Heparin and QPS Diclofenac in prevention of Infusion associated superficial thrombophlebitis

A comparison of Efficacy and safety of Quick penetrating Solution (QPS) Heparin, QPS Diclofenac and Heparin Gel in the prevention of Infusion superficial thrombophlebitis: A randomized double-blind study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041915
Enrollment
219
Registered
2022-04-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I809- Phlebitis and thrombophlebitis ofunspecified site

Interventions

Intervention1: QPS Heparin: patients will receive QPS Heparin 6- 8 drops TDS up to 72 hr. Intervention2: QPS Diclofenac: patients will receive QPS Diclofenac 10 spray TDS up to 72 hr. Control Interv

Sponsors

Dr Vijeta Bajpai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients of either gender aged 18?60 years, belonging to the American Society of Anesthesiologists (ASA) Class I/II undergoing IV cannulation in the wards for at least 72 hrs will be included in our study. 2 Patients willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1 Pre-existing phlebitis at any other cannulation site 2 Unconscious or comatose patients 3 History of hypersensitivity reaction to heparin or heparin-induced thrombocytopenia 4 Patients receiving irritant IV drugs. 5 Signs of systemic infection, bacteremia

Design outcomes

Primary

MeasureTime frame
Primary outcome- 1-To compare the proportion of patients developing no phlebitis (Grade 0) at the end of 72 h of treatment period. 2-To compare proportion of patients developing first signs of infusion phlebitis (Grade I and II) during the 72 h of the treatment period. Timepoint: at the interval of 8 hr upto 72 hr

Secondary

MeasureTime frame
Secondary- Efficacy outcome -To compare mean time to reach infusion phlebitis Grade I and II in hours Recording and reporting of adverse events.Timepoint: at the interval of 8 hr upto 72 hr

Countries

India

Contacts

Public ContactDr Vijeta Bajpai

All India Institute of Medical Sciences, Gorakhpur

drvijeta86gsvm@gmail.com9918724600

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026