Comparative study of the analgesic effect of Morphine Patient control analgesia pumps and Trans-dermal Fentanyl patches in Acute Post Operative Pain management in patients refereed to Mashhad Shahid Kamyab trauma center
With the aim of Comparison of the analgesic effect of Morphine pumps and Fentanyl patches in Acute Post Operative Pain control, we will enroll 200 patients, aged between 15 to 60 years old which have been undergone orthopedic surgeries in Shahid Kamyab accident hospital in this study. After filling the inclusion criteria, they are fully informed and sign the ethical committee forms. Patients will be randomly divided into two groups, for post operation pain control:
In group A, patients will receive IV- Morphine PCA pump. Each pump is filled by 20 mg Morphine diluted in 100 cc normal saline and is set in 1mg/h infusion rate. One bolus dose could be added by the patient if he/she felt undesirable pain. In group B Fentanyl transdermal patches with total dose of 25 μg are used. Regarding the delay action of the patches, they are attached upon the patients arm 18 h before the operation.
The severity of the pain will be registered according to Visual Analogue Scale in specially designed forms by pain-trained nurses in two steps, first after the surgery and before the beginning of analgesic effect; no other analgesic drug will be used at this time. So 24 h after the surgery pain will be assessed again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111147829N2
Registration date:2012-08-17, 1391/05/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-17, 1391/05/27
Registrant information
Name
Hami Ashraf
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1842 4685
Email address
ashrafh821@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Mashhad University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2012-08-03, 1391/05/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the analgesic effect of Morphine Patient control analgesia pumps and Trans-dermal Fentanyl patches in Acute Post Operative Pain management in patients refereed to Mashhad Shahid Kamyab trauma center
Public title
Morphine pump versus trans-Dermal Fentanyl patch In Post surgery Pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with post operative pain; aged from 15 to 60 years; cooperative psychologically Exclusion criteria: patients who need another analgesic method; head trauma or unconsciousness; any medical contraindication; aged beneath 15 or above 60 year
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research Mashhad University of Medical Sciences
Street address
Centeral building of Mashhad University of Medical Sciences (Ghoreishi), Daneshgah Str, Mashhad
City
Mashhad
Postal code
Approval date
2012-03-03, 1390/12/13
Ethics committee reference number
900355
Health conditions studied
1
Description of health condition studied
acute post operation pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
patients' pain
Timepoint
30 minutes after the surgery and then 24 hours later
Method of measurement
0 to 10 visual analogue scale
2
Description
patients' satisfaction
Timepoint
24 hours after the surgery
Method of measurement
0 to 100 designed scale
Secondary outcomes
empty
Intervention groups
1
Description
Morphine pump group: 100cc pumps will be filled with 20mg morphine Diluted in 100cc normal saline. it will be set on 1mg/h infusion rate. one bolus dose could be added by the patients if he/she needs more analgesia
Category
Treatment - Drugs
2
Description
Fentanyl patch group: Fentanyl patches with total dose of 25mg, will be attached upon the patients' arm 18h before the surgery due to 18h delayed action of them.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Shahid-Kamyab accident hospital
Full name of responsible person
Ali Birjandinejad
Street address
Orthopedic and trauma research center, Shahyd Kamyab hospital, Nakhrisi crossroad, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Mashhad University of Medical Sciences
Full name of responsible person
Dr mohsen Tafaghodi
Street address
Vice chancellor of research, centeral building of Mashhad university of medical sciences (Ghoreishi) - Daneshgah Str - Mashhad
City
mashhad
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 Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hami Ashraf
Position
medical doctor
Other areas of specialty/work
Street address
No 6, Building 121, Mirdaman Str, Kuhsangi Ave, Mashhad
City
mashhad
Postal code
Phone
+98 51 1842 4685
Fax
Email
ashrafh821@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Orthopedic and trauma research center-- Mashhad University of Medical Sciences
Full name of responsible person
Ali Birjandinejad
Position
associated professor
Other areas of specialty/work
Street address
Shahyd Kamyab hospital, Nakhrisi crossroad
City
Mashhad
Postal code
Phone
+98 51 1802 6122
Fax
Email
birjandinejada@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hami Ashraf
Position
medical doctor
Other areas of specialty/work
Street address
No 6, Building 121, Mirdamad Str, Kuhsangi Ave, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1842 4685
Fax
Email
mrhami_ashraf@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)