A clinical trial comparing the effect of pethidine and ketorolac on the control of acute pain and postoperative complications of hemorrhoidectomy in patients with hemorrhoids
To compare the effect of pethidine and ketorolac on the control of acute pain and postoperative complications of hemorrhoidectomy in patients with hemorrhoids
Design
90 patients undergoing hemorrhoidectomy in the operating ward of Imam Reza Hospital of Birjand will be divided into two equal groups by simple random allocation to receive either pethidine or ketorolac. All the patients will undergo anesthesia in the same way. The group receiving pethidine will have 0.5 mg/kg of pethidine intravenously immediately after the operation, and will then take the drug at a dose of 50 mg 3 times a day for one day. The group receiving ketorolac will take 0.9 mg/kg of ketorolac intravenously immediately after the operation and will then have 30 mg of the drug three times a day for one day.
Settings and conduct
In this study, 90 patients who are eligible for inclusion in the study will be selected via convenience sampling method. They will be randomly assigned into two intervention groups and each participant will be assigned a code.
Participants/Inclusion and exclusion criteria
Main inclusion criterion involves patients with hemorrhoids in ASA class I and class II aged 18 years and older. Major exclusion criteria: regular or substantial use of opiate, sedative, and tranquilizing drugs; history of pulmonary, hepatic, and renal problems; and history of abdominal surgery.
Intervention groups
Intervention Group 1: The group will have 0.5 mg/kg of pethidine intravenously immediately after the operation, and then takes this drug at a dose of 50 mg 3 times a day for one day.
Intervention Group 2: The group will take 0.9 mg/kg of ketorolac intravenously immediately after the operation and will then have 30 mg of the drug three times a day for one day.
Main outcome variables
Pain severity; complications including nausea, vomiting, and active post-operative bleeding; and patient satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140519017756N44
Registration date:2018-08-21, 1397/05/30
Registration timing:registered_while_recruiting
Last update:2018-08-21, 1397/05/30
Update count:0
Registration date
2018-08-21, 1397/05/30
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-29, 1397/03/08
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial comparing the effect of pethidine and ketorolac on the control of acute pain and postoperative complications of hemorrhoidectomy in patients with hemorrhoids
Public title
Impact of ketorolac and peptidine on the control of acute pain and post-operative complications of hemorroidectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with hemorrhoids in ASA class I and class II
Age older than 18 years
Informed consent for participation
Exclusion criteria:
Regular or substantial use of opiate, sedative, and tranquilizing drugs
History of pulmonary, hepatic, renal problemsHistory of abdominal surgery
Drug addiction and smoking
History of allergy to non-steroidal anti-inflammatory drugs
Brucellosis asthma, pregnancy, preeclampsia, and coagulation disorders
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
After the participants are included in the study, they will be allocated to the study groups randomly via sortification (simple allocation method).
Blinding (investigator's opinion)
Single blinded
Blinding description
Explanations will be provided to the participants concerning the study protocol. However, they will not be aware of the drug they will receive.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2018-05-28, 1397/03/07
Ethics committee reference number
IR.BUMS.REC.1397.048
Health conditions studied
1
Description of health condition studied
hemorrhoid
ICD-10 code
K64.9
ICD-10 code description
Unspecified hemorrhoids
Primary outcomes
1
Description
pain severity
Timepoint
0, 6, 12, and 24 hours after operation
Method of measurement
Visual Analogue Scale
2
Description
Nausea
Timepoint
0, 6, 12, and 24 hours after operation
Method of measurement
Inquiry from the patient
3
Description
vomiting
Timepoint
0, 6, 12, and 24 hours after operation
Method of measurement
Inquiry from the patient
4
Description
Active post-operative bleeding
Timepoint
0, 6, 12, and 24 hours after operation
Method of measurement
Inquiry from the patient
5
Description
patient satisfaction
Timepoint
24 hours after operation
Method of measurement
inquiry from the patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1 (pethidine): The group will have 0.5 mg / kg of pethidine intravenously immediately after the end of operation, and then takes this drug at a dose of 50 mg 3 times a day for one day.
Category
Treatment - Drugs
2
Description
Intervention Group 2 (ketorolac): The group will take 0.9 mg / kg of ketorolac intravenously immediately after the operation and will then have 30 mg of the drug three times a day for one day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Operating department of Imam Reza Hospital
Full name of responsible person
Dr Mohammadreza Ghasemianmoghadam
Street address
Taleghani St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
dr.ghasemian54@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
dr.toobakazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Davood Asadian Ghahfarokhi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ghaffari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5600
Email
asadian.davood@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
drtoobakazemi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
PhD Candidate in Translation Studies
Latest degree
Master
Other areas of specialty/work
Street address
Ghaffari St.,
City
Birjand,
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5680
Fax
Email
Roozgar@BUMS.AC.IR
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Deidentified Individual Participant Data Set
When the data will become available and for how long
After the paper extracted from the project is published and for 6 months
To whom data/document is available
researchers
Under which criteria data/document could be used
for research purposes
From where data/document is obtainable
personal correspondence with the corresponding author
What processes are involved for a request to access data/document