Comparison of the effects of intra venous and epidural fentanyl on pain relief, hemodynamic stability, airway resistance, pulmonary static compliance and arterial blood gas in patients with abdominal and thoracic trauma in ICU.
60 patients with chest or abdominal trauma under mechanical ventilation who admitted to the ICU were included the study. Patients divided into two groups randomly. Each one contains 30 patients. In group 1 intravenous fentanyl at the firs 24 hrs and then for the 2nd 24 hrs via epidural catheter replacement were infused. For group 2 we reversed the order . Between phase 1 and 2 for each group we put 24 hrs fentanyl washout period and for reliving pain during this phase morphin sulphate were administered each 1-2 hr when it was necessary. At 0-2-6-24-50-54-and 72 hrs blood pressure, heart rate, central vein pressure, static compliance, arterial blood gas and airway resistance were determined. SPSS16 was used for statistical analysis between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012205426N1
Registration date:2011-07-11, 1390/04/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-11, 1390/04/20
Registrant information
Name
Mehdi Ahmadinejad
Name of organization / entity
Anesthesiology department, Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 0223 5011
Email address
m.ahmadinejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of intra venous and epidural fentanyl on pain relief, hemodynamic stability, airway resistance, pulmonary static compliance and arterial blood gas in patients with abdominal and thoracic trauma in ICU.
Public title
Comparison of the effects of intra venous and epidural fentanyl on pain reliefو hemodynamic stability, airway resistance, pulmonary static compliance and arterial blood gas in patients with abdominal and thoracic trauma in ICU.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients with 16-80 year old age who are admitted in ICU due to chest or abdominal trauma and are under mechanical ventilation
Exclusion criteria: Age under16 and above 80 yeasr old; BMI>30; Instability of spine; renal or hepatic insufficiency, ischemic heart disease,hypertension, diabetes mellitus; massive transfusion; shock and acute respiratory distress syndrome
Age
From 16 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee, Kerman University of Medical Sciences
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Jahad street
City
Kerman
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
k/89/125
Health conditions studied
1
Description of health condition studied
chest trauma
ICD-10 code
S21.7,S22.
ICD-10 code description
Multiple open wounds of thoracic wall ,Fracture of sternum,Multiple fractures of ribs ,Flail chest
2
Description of health condition studied
Abdomen trauma
ICD-10 code
S31.1,S31.
ICD-10 code description
Open wound of abdominal wall ,Multiple open wounds of abdomen, lower back and pelvis,Other multiple injuries of abdomen, lower back and pelvis
Primary outcomes
1
Description
heart rate-
Timepoint
at 0-2-6-24-50-54-72 hours after admission of patents in icu
Method of measurement
Heart rate with ECG monitoring-
2
Description
ABG
Timepoint
at 0-2-6-24-50-54-72 hours after admission of patents in icu
Method of measurement
ABG analyzer
3
Description
level of consciosness
Timepoint
t 0-2-6-24-50-54-72 hours after admission of patents in icu
Method of measurement
by GCS score
4
Description
static compliance-
Timepoint
at 0-2-6-24-50-54-72 hours after admission of patents in icu
Method of measurement
static compliance from patient data of ventilator
5
Description
airway resistance
Timepoint
at 0-2-6-24-50-54-72 hours after admission of patents in icu
Method of measurement
airway resistance from patient data of ventilator
6
Description
pain score-
Timepoint
at 0-2-6-24-50-54-72 hours after admission of patents in icu
Method of measurement
pain score with visual analog score
7
Description
blood pressure
Timepoint
at 0-2-6-24-50-54-72 hours after admission of patents in icu
Method of measurement
By non invasive BP monitoring of ICU
Secondary outcomes
1
Description
Decrease level of GCS
Timepoint
GCS is evaluated every 2 houre
Method of measurement
consciousness level with GCS-
2
Description
respiratory depression
Timepoint
respratory rate is monitored continiously in ICU
Method of measurement
respiratory rate by icu monitoring devices
3
Description
hypotension
Timepoint
BP is monitored every 1 hour-
Method of measurement
blood pressure with NIBP monitoring
4
Description
Heart rate
Timepoint
heart rate is monitored continiously in ICU
Method of measurement
Heart rate with ECG monitoring-
Intervention groups
1
Description
Insertion of epidural catheter in the level of L1-T11 for administration of fentanyl (1 mic/kg/hour) for pain relief
Category
Treatment - Surgery
2
Description
administration of fentanyl from intravenous line (2mic/kg/hour) for pain relif
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
ICU ward, Shahid Bahonar hospital
Full name of responsible person
Dr. Mehdi Ahmadinejad
Street address
Bahonar hospital
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Dr. Malekpour Afshar
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Jahad street
City
Kerman
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, Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mehdi Ahmadinejad
Position
Assistant professor
Other areas of specialty/work
Street address
ICU ward, Shahid Bahonar hospital
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
+98 34 1226 0100
Email
mehdia50@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehdi Ahmadinejad
Position
Assistant professor
Other areas of specialty/work
Street address
ICU ward, Shahid Bahonar hospital
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
+98 34 1226 0100
Email
m.ahmadinejad@kmu.ac.ir; mehdia50@ gmail.com
Web page address
www.kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehdi Ahmadinejad
Position
Assistant professor
Other areas of specialty/work
Street address
ICU ward, Shahid Bahonar hospital
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
+98 34 1226 0100
Email
m.ahmadinejad@kmu.ac.ir; mehdia50@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)