The comparison of postoperative analgesic effect between Morphine-Apotel and Cetorolac alone with Intravenus patient control analgesia in patients with fracture candidate for the plating surgery in Emam Reza Hospital ,Birjand 1394
This study was performed to compare the analgesic effects between Morphine-Apotel and Ketorolac alone with Intravenous patient control analgesia in patients with fracture candidate for plating surgery.
All patients with fracture, candidate for plating surgery, aged 18 to 50, who underwent general anesthesia were included and patients who were addicted to opium and had contraindication for general anesthesia were excluded. Study population included all fractures candidate for plating surgery and sampling size was estimated 110 patients. The study was performed as double-blind clinical trial on 1394. Patients were randomly divided to Morphine-Apotel or “Ketorolac” Group. Percutaneous control intravenous anesthesia was administered for patients 15 minutes after entry the recovery. In Morphine-Apotel group the pomp was started with a rate of 5 milliliter per hour and dosage of 0.5 milligram per kilogram Morphine plus 40 milligram per kilogram Apotel and in Ketorolac group with the same specifications and dosage of 1 milligram per kilogram. A Questionnaire containing demographic informations, drug groups and degree of pain measured with “Visual Analogue Scale” 0, 6 and 12 hours after surgery, were recorded for all patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015091217607N2
Registration date:2015-11-10, 1394/08/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-10, 1394/08/19
Registrant information
Name
Amin Barati
Name of organization / entity
Birjand Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3222 2600
Email address
aminbarati2009@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University Of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of postoperative analgesic effect between Morphine-Apotel and Cetorolac alone with Intravenus patient control analgesia in patients with fracture candidate for the plating surgery in Emam Reza Hospital ,Birjand 1394
Public title
the comparison of analgesic effect between Morphin-Apotel and Cetorolac alone after plating surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 18-50; all fracture; candidate for plating surgery who underwent general anesthesia .
Exclusion criteria:Patients who underwent spinal or epidural anesthesia; had contraindications for general anesthesia; Patients who were opium addict; Patients with coagulative disorder; platet count under 100000; Patients with chronic renal failure; creatinine levels more than 1.5.
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Emam reza hospital
Street address
Taleqani avenue
City
Birjand
Postal code
Approval date
2015-05-24, 1394/03/03
Ethics committee reference number
ir.bums.1394.25
Health conditions studied
1
Description of health condition studied
Injury of unspecified body region
ICD-10 code
T14,R52
ICD-10 code description
Injury of unspecified body region, Pain, not elsewhere classified
Primary outcomes
1
Description
pain
Timepoint
evry 6 hour
Method of measurement
Visual Analuge Scale
Secondary outcomes
empty
Intervention groups
1
Description
Ketorolac 1 milligrams per kilograms
Category
Treatment - Drugs
2
Description
apotel 40 milligrams per kilograms and morphine 0.5 milligrams per kilograms.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr Pooya Derakhshan
Street address
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Birjand University Of Medical Sciences
Full name of responsible person
Dr Asghar Zarban
Street address
Vice Chancellor for Research,Birjand University of Medical Sieance,Birjand
City
Birjand
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 Birjand 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
Birjand University of medical sience
Full name of responsible person
Dr Pooya Derakhshan
Position
assitant professor
Other areas of specialty/work
Street address
no. 51, sasan St., Velnenjak ST., Tehran, Iran
City
Birjand
Postal code
Phone
+98 56 3239 5000
Fax
Email
pooyaderakh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of medical sience
Full name of responsible person
Dr Pooya Derakhshan
Position
Professor
Other areas of specialty/work
Street address
Moallem Avenue
City
Birjand
Postal code
Phone
+98 56 3239 5000
Fax
Email
pooyaderakh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of medical sience
Full name of responsible person
Faezeh Sheykholvaezin
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
faezeh.vaezin@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)