Comparison of the postoperative analgesia effect of the combination of sufentanil and paracetamol with the combination of ketorolac and paracetamol in open prostatectomy surgery
Comparative study of the analgesic effect of sufentanil and paracetamol in combination with ketorolac and paracetamol in open prostatectomy surgery
Design
Phase 2-3 randomized clinical trial with parallel groups which will be conducted on 60 patients candidate for open prostatectomy.
Settings and conduct
In this study, 60 prospective candidates for open prostatectomy were referred to the Ali ibn Abi Talib hospital in Zahedan whom have inclusion criteria are enrolled. Participants are randomly divided into intervention and control groups. Individuals in the intervention group (the Ketorolac group) will receive one mg/kg body weight of ketorolac plus 35 mg per kg of paracetamol, and the control group (sufentanil group) will also receive 0.1 mg / kg Of body weight will receive sufentanil with 35 mg per kg of paracetamol. 4, 8, 12, 24, 36 and 48 hours after surgery, pain intensity will be measured in two groups using visual analogue pain scale and compared in two groups.
Participants/Inclusion and exclusion criteria
Main inclusion criteria: All candidate patients for open prostatectomy referring to Ali ibn Abi Talib (AS) hospital in Zahedan. Major exclusion criteria: Drug use, narcotic drugs or psychiatric drugs; Renal failure; Hepatic failure; Gastrointestinal disease; Opioid, ketrolac and paracetamol allergy; Spinal anesthesia contraindication; General anesthetic contraindication; Failure of spinal anesthesia and switch to general anesthesia; Respiratory depression while receiving a pump of pain.
Intervention groups
The intervention group (the Ketorolac group) received one mg / kg body weight of ketorolac plus 35 mg per kg of body weight paracetamol
The control group (sufentanil group) received 0.1 mg / kg body weight of sufentanil with 35 mg per kg body weight paracetamol.
Main outcome variables
The severity of postoperative pain; the amount of need for excess analgesia; sedation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171111037369N2
Registration date:2018-02-28, 1396/12/09
Registration timing:registered_while_recruiting
Last update:2018-02-28, 1396/12/09
Update count:0
Registration date
2018-02-28, 1396/12/09
Registrant information
Name
Shadab Jafarizade
Name of organization / entity
Zahedan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 54 3322 3002
Email address
shadab.jfz@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-25, 1396/04/04
Expected recruitment end date
2018-06-25, 1397/04/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the postoperative analgesia effect of the combination of sufentanil and paracetamol with the combination of ketorolac and paracetamol in open prostatectomy surgery
Public title
Evaluation of the analgesic effect of sufentanil and paracetamol in comparison with the combination of ketorolac and paracetamol in open prostatectomy surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients candidate for open prostatectomy
Exclusion criteria:
usage of opioid, analgesic or psychiatric drugs
renal failure
hepatic diseases
gastrointestinal diseases
patient who have allergic history to opium, ketorolac, paracetamol
contraindications for spinal anesthesia
contraindications for general anesthesia
spinal anesthesia failure and convertion to general anesthesia
respiratory depression during IV-PCA infusion
Age
No age limit
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization with quadrilateral blocks
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
Ethics Committee of Zahedan Medical University of Science
Street address
Ethics Committee of Zahedan Medical University of Science, Zahedan Medical University of Science, Dr.Hesabi Square, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2017-06-25, 1396/04/04
Ethics committee reference number
IR.ZAUMS.REC.1396. 75
Health conditions studied
1
Description of health condition studied
Open prostatectomy
ICD-10 code
N52.34
ICD-10 code description
Erectile dysfunction following simple prostatectomy
Primary outcomes
1
Description
Severity of postoperative pain
Timepoint
4, 8, 12, 24, 36 and 48 hours after surgery
Method of measurement
Visual Analogue Scale
2
Description
Sedation
Timepoint
4, 8, 12, 24, 36 and 48 hours after surgery
Method of measurement
Ramssay score
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: received one mg / kg body weight of ketorolac plus 35 mg per kg of body weight paracetamol
Category
Treatment - Drugs
2
Description
Intervention group: received 0.1 mg / kg body weight of sufentanil with 35 mg per kg body weight paracetamol
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ebn abi talib Zahedan Hospital
Full name of responsible person
Dr Asadollah Shakeri
Street address
Zahedan Ali-ebn Abi Talib Hospital, Salamat Blvd, Dr.Hesabi Sq., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5721
Email
mrs.ameri2010@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5721
Email
Dr.Taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Shadab Jafarizadeh
Position
Anesthesiology Residence
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Zahedan Ali-ebn Abi Talib Hospital, Salamat Blvd, Dr.Hesabi Sq., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5721
Email
mrs.ameri2010@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Asadollah Shakeri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Operation room, Ali-ebn Abi Taleb Hospital, Hesabi Sq., Daneshgah Ave., Zahedan, Sistan and Balouchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5730
Fax
Email
Dr.Shakeri@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Shadab Jafarizadeh
Position
Anesthesia Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Operation room, Ali-ebn Abi Taleb Hospital, Hesabi Sq., Daneshgah Ave., Zahedan, Sistan and Balouchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5731
Email
shadab.jfz@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available