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IRCT20131228015965N19 IRCT 2020-06-17 Rafsanjan University of Medical Sciences Investigating Comparison of topical Rosemary and Nitroglycerine ointment on incidence time of Phlebitis due to peripheral catheterization Investigating Comparison of topical Rosemary and Nitroglycerine ointment on incidence time of Phlebitis due to peripheral catheterization in children 2020-06-20 anticipated 144 Complete https://irct.ir/trial/47938 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Accidental block randomization based on age and sex The 6-person block includes two in the Rosemary group, two in the nitroglycerin group, and two in the control group. For random sequencing in each block,Roll a dice is used in such a way that the numbers 1 and 2 for the first block (Rosemary), 3 and 4 for the second block (nitroglycerin), 5 and 6 for the third block (control) are considered, Blinding description: This study is double blind. That Participants are not aware of the type of material used in the intervention. Also person evaluating the phlebitis that she only examines the location of the angiocatheter for sign of phelebitis would be blind. 3 Phlebitis. Intervention 1: Intervention group1 :Intervention group receiving Rosemary ointment, produced by Gol Daroo Isfahan Company, Product Ingredients: Every 30 grams of ointment containing 2.4 grams of rosemary essential oil, 2.1 grams of camphor, 1/2 mg of menthol 0.5 cc of ointment once a day for three days after Putting angiocatheter at the site below the angiocatheter entry site and Every 12 hours, the symptoms of phlebitis are assessed by the VIPAS. Intervention 2: Intervention group 2 :receiving Nitroglycerin ointment CHEM A-ELEKTROMET [Poland] used 2% nitroglycerin ointment at a dose of 2.5 mg (equivalent to 10 units of insulin syringes) once a day for three days after Putting angiocatheter at the site below the angiocatheter entry site and Every 12 hours, the symptoms of phlebitis are assessed by the VIPAS. Intervention 3: Control group:receiving ucerin ، 0.5 cc of ucerin once a day for three days after Putting angiocatheter at the site below the angiocatheter entry site and Every 12 hours, the symptoms of phlebitis are assessed by the VIPAS. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is they aren't information
public Majid Kazemi
Rafsanjan University of Medical Sciences Imam Ali Boulevard Rafsanjan
Rafsanjan Iran (Islamic Republic of) 7717937555 +98 34 3425 5900 dr.kazemi.n@rums.ac.ir Rafsanjan University of Medical Sciences scientific Dr. Majid Kazemi
Rafsanjan University of Medical Sciences Imam Ali Boulevard Rafsanjan
Rafsanjan Iran (Islamic Republic of) 7717937555 +98 34 3425 5900 dr.kazemi.n@rums.ac.ir Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Children hospitalized in Shahid Sadoughi Hospital Having an age of 1 to 12 years Parental satisfaction for the child's participation in the study Failure to receive chemotherapy drugs Lack of underlying diseases such as diabetes and autoimmune diseases and skin infections Do not use steroids, immunosuppressive drugs and anticoagulants Need a catheter for at least 72 hours 1 year 12 years Both previous phlebitis at the site of angiocatheter placement skin and peripheral vascular disease Sensitivity to nitroglycerin or Rosemary ointment I80 Phlebitis and thrombophlebitis Treatment - Drugs Treatment - Drugs Placebo Intervention group1 :Intervention group receiving Rosemary ointment, produced by Gol Daroo Isfahan Company, Product Ingredients: Every 30 grams of ointment containing 2.4 grams of rosemary essential oil, 2.1 grams of camphor, 1/2 mg of menthol 0.5 cc of ointment once a day for three days after Putting angiocatheter at the site below the angiocatheter entry site and Every 12 hours, the symptoms of phlebitis are assessed by the VIPAS. Intervention group 2 :receiving Nitroglycerin ointment CHEM A-ELEKTROMET [Poland] used 2% nitroglycerin ointment at a dose of 2.5 mg (equivalent to 10 units of insulin syringes) once a day for three days after Putting angiocatheter at the site below the angiocatheter entry site and Every 12 hours, the symptoms of phlebitis are assessed by the VIPAS. Control group:receiving ucerin ، 0.5 cc of ucerin once a day for three days after Putting angiocatheter at the site below the angiocatheter entry site and Every 12 hours, the symptoms of phlebitis are assessed by the VIPAS. Phlebitis score based on Visual Infusion Phlebitis Assessment Scale criteria. Timepoint: Every 12 hours to 72 hours. Method of measurement: Visual Infusion Phlebitis Assessment Scale Grade 1 has none of the typical symptoms of phlebitis such as pain, rash, and edema. Only catheter observation is recommended. Grade 2 describes the early symptoms of phlebitis, such as pain upon palpation and a rash less than 2.5 cm in diameter around the catheter site. Visual Infusion Phlebitis Assessment Scale suggests catheter replacement. Grade 3 phlebitis refers to mid-level disease: IV site rashes are between 2.5 and 5 cm, and palpation of the IV site reveals pain and rigidity. Treatment should be considered after catheter replacement and doctor notification. Grade 4 phlebitis is advanced phlebitis or the onset of thrombophlebitis. At this level, there is a rash larger than 5 cm around the IV site and pain and rigidity upon palpation. Visual Infusion Phlebitis Assessment Scale recommends catheter replacement, doctor consultation, and consideration of treatment. Finally, grade 5 phlebitis describes advanced thrombophlebitis. This grade includes grade 4 symptoms as well as purulent drainage. Recommendations include treatment consideration after catheter replacement and doctor notification. Rafsanjan University of Medical Sciences Approved 2020-02-18 Research ethics committee of Rafsanjan University of Medical Sciences Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan Rafsanjan Kerman Iran (Islamic Republic of)