Background : Chest tube removal is a painful procedure.there is no study on indometacin in combination with cold on chest tube removal pain.
Aim: to examine the effect of cold application in combination with Indomethacin suppository on chest tube removal pain in patients undergone open heart surgery .
Material and Methods: In this single blind randomized control trial 66 open heart surgery paients with chest tube were allocated in two groups randomly. Experimental group received 100 mg Indomethacin suppository one hour before Chest tube removal. A +4º c cold pack was placed on chest tube site 20 minutes before removing chest tube. In control group 100 mg Indomethacin suppository was prescribed one hour before chest tube removal.we use same cold pack with room temprature as placebo and placed it on chest tube site 20 minutes before removing chest tube. Pain intensity was evaluated by the visual analog scale 20 minutes before, after and 15 minutes after chest tube removal.
Key words: pain, cold therapy, Indomethacin, chest tube.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205169664N2
Registration date:2012-06-06, 1391/03/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-06, 1391/03/17
Registrant information
Name
Mitra Payami Bousari
Name of organization / entity
Zanjan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 24 3315 6962
Email address
payami@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
all funds is supplied by Vice-chancellor for Research of Zanjan University of Medical Sciences
Expected recruitment start date
2011-04-04, 1390/01/15
Expected recruitment end date
2011-11-06, 1390/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cold application in combination with Indomethacin suppository on chest tube removal pain undergone open heart surgery patients.
Public title
The effectiveness of cold application in combination with Indomethacin suppository on chest tube removal pain undergone open heart surgery patients.
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patients undergo sternomy surgery, range of age :18-69, oriented to time and place, able to answer to questions, not addicted to drug , no smoking , Indometacin suppository or other kind of sedative have not being prescribed at least 6 hours before intervention also having no opoids prescription 12 hours before intervention, having at least one chest tube in pluera, having physician order for removing chest tube ,
exclusion criteria: sudden change in patient status during the intervention, pain in other organs which affect chest tube removal pain such as heart pain
Age
From 18 years old to 69 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences & health services
Street address
Azadi Square,Zanjan University of Medical Sciences and Health Services
City
Zanjan
Postal code
45156-13191
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
8912315
2
Ethics committee
Name of ethics committee
Ethics comittee of Vice-chancellor for Research of Zanjan university of medical sciences and health
Street address
Azadi Square,Zanjan University of Medical Sciences and Health Services
City
Zanjan
Postal code
45156-13191
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
8912315
Health conditions studied
1
Description of health condition studied
chest tube removal pain
ICD-10 code
I00-I99
ICD-10 code description
Primary outcomes
1
Description
pain of chest tube removal
Timepoint
20 minutes before CTR , just after and 15 minutes after CTR
Method of measurement
visual analog scores (VAS)
Secondary outcomes
1
Description
vital sign including Blood pressure, pulse, respiratory rate
Timepoint
20 minutes before CTR, just after and 15 minutes after intervention
Method of measurement
mm/hg for BP, nomber for Pulse and respiratory rate announced by vital sign monitoring system Pooyandegan rahe Saadat made by iran
Intervention groups
1
Description
In Intervention group 100 mg Indomethacin suppository will be administered one hour before Chest tube removal. In intervention group a 4º c cold pack will be placed on chest tube site 20 minutes before removing chest tube. pain intensity evaluated by the visual analog scale three times:20 minutes before, just after and 15 minutes after chest tube removal.
In controrl group: 100 mg Indomethacin suppository will be administered one hour prior to Chest tube removal. In control group same cold pack with room tempreature (as placebo) will be placed on chest tube site 20 minutes before removing chest tube. pain intensity evaluated by the visual analog scale three times:20 minutes before, just after and 15 minutes after chest tube removal.
Category
Treatment - Other
2
Description
control group: 100 mg Indomethacin suppository will be administered one hour prior to Chest tube removal. In control group same cold pack with room tempreature (as placebo) will be placed on chest tube site 20 minutes before removing chest tube. pain intensity evaluated by the visual analog scale three times:20 minutes before, just after and 15 minutes after chest tube removal.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Aallinasab Hospital
Full name of responsible person
Dr. Eskanndar Nourizadeh, Cardiologist of Aallinasab hospital of Tabriz
Street address
Tabriz, Aallinasab hospital affiliated to social security services
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research of Zanjan University of Medcial Sciences and Health Services
Full name of responsible person
Dr. Alireza Biglari
Street address
Zanjan, Zanjan University of Medical Sciences and Health Services, Research
City
Zanjan
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 Zanjan University of Medcial Sciences and Health Services
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
Zanjan University of Medcial Sciences and Health Services
Full name of responsible person
Mitra Payami Bousari
Position
PhD, Assisstant professor
Other areas of specialty/work
Street address
Zanjan, Nursing and midwifery faculty of Zanjan University of Medical Sciences and Health Services, Parvin Eesami Ave.,\
City
Zanjan
Postal code
4515786339
Phone
+98 24 1727 2057
Fax
Email
payami@zuma.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medcial Sciences and Health Services
Full name of responsible person
Mitra Payami Bousari
Position
PhD, Assistant professor
Other areas of specialty/work
Street address
Zanjan, Nursing and Midwifery faculty of Zanjan University of Medical Sciences and Health Services, Parvin Etesami Ave.
City
Zanjan
Postal code
4515786339
Phone
+98 24 1727 2057
Fax
Email
payami@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medcial Sciences and Health Services
Full name of responsible person
Mitra Payami Bousari
Position
PhD, Assisstant professor
Other areas of specialty/work
Street address
Parvin Etesami Ave., Nursing and Midwifery faculty of Zanjan University of Medical Sciences and Health Services
City
Zanjan
Postal code
4515786339
Phone
+98 24 1727 2057
Fax
+98 24 1727 0305
Email
payami@zums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)