Comparative efficacy, safety and pharmaco-economic evaluation of dressing with “heparinoid preparationâ€, “Magnesium Sulphate-glycerine†and “Ichthammol glycerine†on phlebitis following peripheral intravenous cannulation: A double blinded randomized clinical trial,ACC, PGIMER, Chandigarh
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Study result helps in the provision of the most effective intervention for the management of post infusion intravenous cannulation phlebitis
研究概览
简要总结
This study aims at Comparative efficacy, safety and pharmaco-economic evaluation of dressing with “heparinoid preparationâ€, “Magnesium Sulphate-glycerine†and “Ichthammol glycerine†on phlebitis following peripheral intravenous cannulation. The medical science and technology has been progressing and is accompanied by the use of new diagnostic and therapeutic devices. Peripheral intravenous catheter is one of the most commonly used device for the infusion of medications fluids and blood products.Phlebitis is the most common complications associated with intravenous therapy. In PGIMER, Chandigarh the treatment measures for phlebitis include heparinoid application or Magsulph- glycerine application, but not on any fixed manner. All the measures have been found to be effective for the treatment of phlebitis. But there is not much evidence to identify the most effective measure for reducing the signs and symptoms of phlebitis. In PGIMER,Chandigarh no studies have been done to compare the effectiveness of the most commonly used treatment options ie.Magsulf- glycerine and heparinoid application on phlebitis. Therefore a study needs to be conducted to determine the prevalence of phlebitis and to identify the effective treatment measure for the management of phlebitis.
The data was collected from the wards of advanced cardiac centre for the time period of 6 weeks from 15/07/2013 to 31/08/2013. Randomised Trial design was used to measure and compare the effectiveness of heparinoid application and ichthammol glycerine and magsulf-glycerine application on the reduction of the phlebitis. The wards of ACC, PGIMER, Chandigarh were assigned to each interventional group(either heparinoid application or ichthammol glycerine or magsulf-glycerine application ) by computer generated Block randomisation method.
Every day the patients with intravenous cannula who fullfill the inclusion criteria were assessed for phlebitis by using visual infusion phlebitis scale.The investigator explained the purpose of the study and obtained written informed consent from the participants.The observerational and participational blinding had done. The observer used to give marks by using the visual infusion phlebitis scale and numeric pain intensity scale .The patients were tested for allergic skin reaction before the administration of the intervention. All the interventions were given two times per day (12 hrsly) for 72 hrs or till the reduction of phlebitis score to 0.Time taken for the application of each intervention also was noted. First observation was done after 24 hours of the application of the intervention, second observation at 48 hours, third observation at 72 hours to Compare the efficacy, safety and pharmaco-economic evaluation of dressing with “heparinoid preparationâ€, “Magnesium Sulphate-glycerine†and “Ichthammol glycerine†on phlebitis following peripheral intravenous cannulation. None of the participants develop allergic skin reaction .For all the subjects who participated in the study ,phlebitis resolved with in 48-72 hours.
Currently analysis is under process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients admitted in ACC,PGIMER,Chandigarh and develop phlebitis as the result of intravenous therapy.
- ••Patients with visual infusion phlebitis score of two or more •Patients with infusion related phlebitis and not received any form of intervention by the staff •Patients who develop phlebitis only on the upper limbs.
排除标准
- •The patient/ legally acceptable representatives who are not willing to participate the study.
- •Patients who will be receiving chemotherapeutic agents •Patients with central venous catheter on the same limb. •Patients with dermatological disorders. •Patients with any bleeding disorders,injury to the same limb,pre-existing lymphatic obstruction. •Patients who are allergic to heparinoid or ichthammol glycerine or magsulph.
结局指标
主要结局
Study result helps in the provision of the most effective intervention for the management of post infusion intravenous cannulation phlebitis
时间窗: 6 weeks
次要结局
- Study result helps in the provision of the most pharmacoeconomic intervention for the management of post infusion intravenous cannulation phlebitis(6 weeks)
