Comparison of topical effect of rosemary ointment with nitroglycerin ointment At the time of phlebitis due to peripheral catheterization in children.
Design
Clinical practice with control group, double blind, randomized
Settings and conduct
The sample size is 144 samples fromShahid Sadoughi Hospital in Yazd . Patients are randomly divided into two intervention groups and one control group. In the intervention groups, after fixing the catheter rosemary or nitroglycerin ointment is applied in the area below the catheter site and in the control group Ocerin ointment it is used once a day for up to three days. The phlebitis check list will be recorded according to the VIPAS criterion.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Children hospitalized in Shahid Sadoughi Hospital
Having an age of 1 to 12 years
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
No previous phlebitis at the site of angiocatheter placement
Lack of skin and peripheral vascular disease
Lack of sensitivity to nitroglycerin ointment or Rosemary ointment
Intervention groups
In a group of rosemary ointments (1 cm in size), 0.5 cc of ointment is applied once a day for three days after Putting angiocatheter at the site below the angiocatheter entry site, followed by sterile gauze and It is covered and fixed with anti-allergy glue and fixed with a splint.In the other group, 2% nitroglycerin ointment is used in the same way with a dose of 2.5 mg (equivalent to 10 units of insulin syringe)and used in the same way in the control group of ucerine ointment.
Main outcome variables
phlebitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131228015965N19
Registration date:2020-06-17, 1399/03/28
Registration timing:prospective
Last update:2020-06-17, 1399/03/28
Update count:0
Registration date
2020-06-17, 1399/03/28
Registrant information
Name
Majid Kazemi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 7663
Email address
dr.kazemi.n@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-20, 1399/03/31
Expected recruitment end date
2020-10-20, 1399/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating Comparison of topical Rosemary and Nitroglycerine ointment on incidence time of Phlebitis due to peripheral catheterization in children
Public title
Investigating Comparison of topical Rosemary and Nitroglycerine ointment on incidence time of Phlebitis due to peripheral catheterization
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
previous phlebitis at the site of angiocatheter placement
skin and peripheral vascular disease
Sensitivity to nitroglycerin or Rosemary ointment
Age
From 1 year old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Rafsanjan University of Medical Sciences
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Approval date
2020-02-18, 1398/11/29
Ethics committee reference number
IR.RUMS.REC.1398.194
Health conditions studied
1
Description of health condition studied
Phlebitis
ICD-10 code
I80
ICD-10 code description
Phlebitis and thrombophlebitis
Primary outcomes
1
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
3
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr. Majid Kazemi
Street address
Shahid Sadoughi Hospital Ibn Sina Boulevard Shahid Ghandi Boulevard safaie Yazd
City
yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 1822 4000
Fax
+98 35 1822 4100
Email
dr.kazemi.n@rums.ac.ir
Web page address
http://vcrt.rums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Ali Shamsizadeh
Street address
Rafsanjan University of Medical Sciences Imam Ali Boulevard Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0086
Email
ashamsi@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Majid Kazemi
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rafsanjan University of Medical Sciences Imam Ali Boulevard Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3425 5900
Email
dr.kazemi.n@rums.ac.ir
Web page address
http://vcrt.rums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Majid Kazemi
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rafsanjan University of Medical Sciences Imam Ali Boulevard Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3425 5900
Email
dr.kazemi.n@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Majid Kazemi
Position
PHD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rafsanjan University of Medical Sciences Imam Ali Boulevard Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3425 5900
Email
dr.kazemi.n@rums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available