Objective; this study is performed to assess the effect of sesame oil on prevention of phlebitis caused by peripheral vein infusion of Amiodarone. 2. Design; this study is a controlled randomized double blind clinical trial.3. Setting and conduct; thirty six eligible patients will be randomly placed in experimental and control groups. At first demographic and clinical characteristics of the patients will be recorded in questionnaire. 4. Inclusion major criteria; being over 18 years old, don't have any history of allergy to the sesame seeds, using of the upper extremity for intravenously catheterization. Exclusion criteria; having autoimmunity disease, using analgesics and narcotics to mitigate pain continuously, using drugs or herbal oil to prevent phlebitis during the study, Bradycardia and death of the patient. 5. Intervention; thirty six cardiac patients that receive peripheral intravenous Amiodarone will be randomly divided into two groups. The phlebitis will be measured with Visual infusion phlebitis Scale (VIP) in two groups. In the experimental group, at first the catheterization is performed observing aseptic conditions.Then before the injection of first dose of Amiodarone, as 5 drops of pure sesame oil (produced by Barij Essence,Kashan,Iran) will be rubbed around 10 cm around the area of intravenous Amiodarone injection are applied. And then Amiodarone infusion start and sesame oil will be rubbed every 6 hours during 24 hours (4 times) in the area. In control group will be rubbed liquid paraffin (produced by MERK.Germany.cod:1.07160) as placebo. The amount and method of using liquid paraffinis as exactly same as using of sesame oil in the experimental group. Phlebitis will be measure consecutive 30 hours in each group.6 main outcome measures variables; Effects of sesame oil on prevention of phlebitis caused by peripheral vein infusion of Amiodarone.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308127494N7
Registration date:2014-03-11, 1392/12/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-11, 1392/12/20
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Science, Moalem square , Moalem street ,Sari.
Expected recruitment start date
2013-12-31, 1392/10/10
Expected recruitment end date
2014-03-30, 1393/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of sesame oil on prevention of phlebitis caused by peripheral vein infusion of amiodarone in cardiac patient.
Public title
Effects of sesame oil on prevention of phlebitis caused by peripheral vein infusion of amiodarone.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion major criteria; being over 18 years old; don't have any history of allergy to the sesame seeds; using of the upper extremity for intravenously catheterization.
Exclusion major criteria; having autoimmunity disease; using analgesics and narcotics to mitigate the pain continuously; using drugs or herbal oil to prevent phlebitis during the study; Bradicardia and death of the patient.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research of Mazandaran University of Medical Science, Moalem square , Moalem street ,Sari.
City
Sari
Postal code
4758173676
Approval date
2014-03-05, 1392/12/14
Ethics committee reference number
92-570
Health conditions studied
1
Description of health condition studied
phlebitis
ICD-10 code
I80.0
ICD-10 code description
Phlebitis and thrombophlebitis of other sites
Primary outcomes
1
Description
phlebitis
Timepoint
Before and during the study-Phlebitis will be measure consecutive 30 hours in each group
Method of measurement
visual infusion phlebitis scale
Secondary outcomes
1
Description
Prevention of phlebitis
Timepoint
after intervention, Phlebitis will be measure consecutive 30 hours in each group
Method of measurement
Visual infusion phlebitis Scale (VIP)
Intervention groups
1
Description
Intervention1: In the experimental group, at first the catheterization is performed observing aseptic conditions.Then before the injection of first dose of Amiodarone, as 5 drops of pure sesame oil (produced by Barij Essence,Kashan,Iran) will be rubbed around 10 cm around the area of intravenous Amiodarone injection are applied. And then Amiodarone infusion start and sesame oil will be rubbed every 6 hours during 24 hours (4 times) in the area.Essance,Kashan,Iran) as 5 drops of around 10 cm in the path where the intravenous amiodarone injection are applied. And then amiodarone infusion start and sesame oil is applied every 6 hours to 24 hours(4 times) in the area
Category
Treatment - Drugs
2
Description
Intervention2: In control group will be rubbed liquid paraffin (produced by MERK.Germany.cod:1.07160) as placebo. The amount and method of using liquid paraffinis as exactly same as using of sesame oil inthe experimental group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yahya Nejad Babol Haspital
Full name of responsible person
Seyedeh Zahra Hashemi Karoie
Street address
Yahya Nejad Hospital. martyr Mostafa Khomeini, the Farhang Cross, Babol.
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Science
Full name of responsible person
Dr Ahmad Ali Enayeti
Street address
Vice chancellor for research of Mazandaran University of Medical Science, Moalem square , Moalem street ,Sari.
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Mazandaran University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Science
Full name of responsible person
Dr Mohamad Ali Heydari Gorji
Position
Phd- faculty
Other areas of specialty/work
Street address
Nasibeh School of Nursing and Midwifery,Vesal St, Amir St, Sari.
City
Sari
Postal code
4816715793
Phone
+98 15 1326 1245
Fax
Email
heydarigorji@yahoo.com
Web page address
www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences.
Full name of responsible person
Masoumeh Bagheri Nesami
Position
PHD/member of faculty
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Imam Square, Highway Bassij, 3-way Jouibar, Sari, Mazandaran.
City
Sari
Postal code
4816715793
Phone
+98 15 1226 7342
Fax
Email
anna3043@gmail.com
Web page address
www.mazums.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)