This study aimed to investigate the effect of chamomile ointment on the incidence of phlebitis caused by amiodaron infusion through a peripheral vein. In a double-blind clinical trial, 42 patients will be treated with amiodarone for 24 hours in one of the two groups are based on random selection: Placebo and treatment groups. After random selection of chamomile or placebo ointment is applied in IV cannula place every 8 hours for 3 days and during this period the incidence of phlebitis checked with phlebitis scale. Amiodarone will be injected from a single IV injection the patient did not receive any medication through that cannula.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042017361N1
Registration date:2014-06-02, 1393/03/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-02, 1393/03/12
Registrant information
Name
Marjan Nassiri-Asl
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
mnassiriasl@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qaznin University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of chamomile ointment on iIncidence of phlebitis caused by intravenous amiodarone in cardiac care unit in selected Qazvin's hospitals: 2013
Public title
Effect of chamomile ointment on incidence of phlebitis caused by amiodarone
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Treated with amiodarone for 24 hours; Not allergic to chamomile ointment; Not diabetic; Age 18 to 75 years
Exclusion criteria: Chamomile Ointment sensitivity expressed by patients before study entry or during the study period, based on the research team ;Scar, surgical scar or deformity that prevented IV cannula insertion of the upper limbs; Peripheral vascular disease; Use of chemotherapy medication; To prescribe oral or injectable anti-inflammatory drugs during the study period; The patient does not consent to continue to participate in the study; IV cannula exit; The drug discontinue before 24 hours; Diagnosis of diabetes after study entry; Cancer history; Patient expired; Patient discharge
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Qazvin University of Medical Sciences
Street address
Deputy of Research, Bahonar Blvd, Qazvin University of Medical Scieces
City
Qazvin
Postal code
Approval date
2014-03-02, 1392/12/11
Ethics committee reference number
8486/20/28
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
Timepoint
Fisrt, Second and third 24 h
Method of measurement
Check list for phelebitis VIP (score 0-4)
Secondary outcomes
empty
Intervention groups
1
Description
This study is randomized double blind clinical trials.
Drug group:
The patients with ventricular or supraventricular arrhythmias that will admitted in the cardiac care unit will be treated with amiodarone for 24 h. Infusion of amiodarone with 150 mg over 10 min and with 6 mg/min for 6 h and 0.5 mg/min for 18 h will be continued. Chamomile ointment as a fingertip will apply ten cm above the IV injection route of amiodarone, as the skin is completely covered with ointment and it will be repeated every 8 hours for three days. During this time, the location will be checked of phlebitis, pain, swelling, redness by researcher every 8 hours and if needed.
Category
Prevention
2
Description
Control group:
The patients with ventricular or supraventricular arrhythmias that will admitted in the cardiac care unit will be treated with amiodarone for 24 h. Infusion of amiodarone with 150 mg over 10 min and with 6 mg/min for 6 h and 0.5 mg/minute for 18 h will be continued. Placebo ointment as a fingertip will apply ten cm above the IV injection route of amiodarone, as the skin is completely covered with ointment and it will be repeated every 8 hours for three days. During this time, the location will be checked of phlebitis, pain, swelling, redness by researcher every 8 hours and if needed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
BuAli Hospital
Full name of responsible person
Maryam Sharifi
Street address
BuAli Hospital, BuAli Ave
City
Qazvin
2
Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Maryam Sharifi
Street address
Velayat Hospital, Minodar Ave
City
Qazvin
3
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Maryam Sharifi
Street address
Razi Hospital, Daneshgah Ave
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr.Saeed Asefzadeh
Street address
Qazvin University of Medical Sciences, Bahonar Blvd
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
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
Qazvin University of Medical Sciences
Full name of responsible person
Dr.Marjan Nassiri-Asl
Position
Supervisor/Ph.D Pharmacology
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar Blvd