Assessing analgesia in mixed administrations of ketorolac + low dose pethidine comparison with pethidine after elective laparotomy leading to colectomy
Assessing analgesia in mixed administrations of ketorolac + low dose pethidine comparison with pethidine after elective laparotomy leading to colectomy
Design
This study is a randomized clinical trial (randomized blocks) without blinding, which will be performed with the participation of 100 patients who are candidates for colectomy in Imam Reza Hospital (Tabriz). This study is in parallel groups and has 2-3 phases.
Settings and conduct
This clinical trial study will be performed with the participation of 100 patients in Imam Reza Hospital (Tabriz). Patients will be divided into two groups by random allocation (random blocks). This study is without blinding and patients are divided into two groups after surgery so that the first group will receive low-dose ketorolac + pethidine and the second group will receive pethidine intravenously after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria include weight between 45 and 115 kg and candidate for elective laparotomy leading to colectomy, and exclusion criteria include gastritis, disorders, unknown bleeding, pregnant women, opioid addiction.
Intervention groups
100 patients who are candidates for colectomy surgery will be divided into two groups after random allocation by random block method. The first group will receive low-dose ketorolac + pethidine after surgery and the second group will receive pethidine after surgery. This study will be performed in Imam Reza Hospital (Tabriz) and blinding has not been performed in this study.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N20
Registration date:2020-12-31, 1399/10/11
Registration timing:prospective
Last update:2020-12-31, 1399/10/11
Update count:0
Registration date
2020-12-31, 1399/10/11
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-19, 1399/10/30
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing analgesia in mixed administrations of ketorolac + low dose pethidine comparison with pethidine after elective laparotomy leading to colectomy
Public title
ketorolac + low dose pethidine comparison with pethidine after elective laparotomy leading to colectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Weight between 45 to 115 kg
Candidate elective laparotomy leading to colectomy
Exclusion criteria:
Getting gastritis
Having unknown bleeding disorders
Pregnant women
Opioid addiction
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups by random allocation method. The balanced (permuted) block randomization will be used for random allocation and patients will be divided into two groups of ketorolac + pethidine and pethidine ; Thus, first 6 possible modes of blocks (BAAB, ABBA, BABA, AABB, ABAB, BBAA) were listed and each block was assigned a number from 1 to 0. Then, a number between 1 and 0 was randomly selected and the subjects were assigned to the experimental group (A) and placebo (B) based on the relevant block and the selected number.
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2020-01-20, 1398/10/30
Ethics committee reference number
IR.TBZMED.REC.1398.1163
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.29
ICD-10 code description
Other chronic pain
Primary outcomes
1
Description
Pain
Timepoint
The intervention will start immediately after the end of the surgery and will continue for up to two days after the surgery. The study variable will be measured every six hours from the beginning of the study for three days with the help of VAS instrument.
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will be randomly assigned to this group and will receive ketrolac (4 mg) + pethidine (40 mg) intravenously every 8 hours after elective colectomy; The severity of the pain will then be measured using a VAS instrument every eight hours.
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group: Patients will be randomly assigned to this group and will receive pethidine (40 mg) intravenously every 8 hours after elective colectomy; The severity of the pain will then be measured using a VAS instrument every eight hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Touraj Asvadi
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 41 3335 5921
Email
T.asvadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Tabriz University of Medical Sciences, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
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