Comparison of the effectiveness of two combined drug regimens of venous ketorolac and diclofenac suppository in comparison with venous ketorolac alone on reducing pain after abdominal surgery under general anesthesia
Comparison of the effectiveness of two combination regimens of intravenous ketorolac and diclofenac suppository compared to intravenous ketorolac alone on reducing pain after abdominal surgery with general anesthesia
Design
Clinical trial, with parallel groups, double-blind, randomized, on 44 patients, using a table of random numbers
Settings and conduct
In the field of pain reduction after surgery, at Amirul Munin Hospital in Tehran, on two groups of 22 people, a double-blind study was conducted in which neither the patients nor the surgeon will know about the randomization method and the treatment protocol.
Participants/Inclusion and exclusion criteria
Entry: age over 18 years, undergoing all kinds of elective abdominal surgeries under general anesthesia, anesthesia class one and two
Non-entry: the presence of any disease limiting the use of NSAID (patients with gastrointestinal, liver, kidney disorders); occurrence of surgery and anesthesia complications.
Intervention groups
Comparison of the effectiveness of two combination regimens of intravenous ketorolac and diclofenac suppository compared to intravenous ketorolac alone on reducing pain after abdominal surgery with general anesthesia
Main outcome variables
Comparing the effectiveness of Ketorolac and Diclofenac on reducing pain after abdominal surgery with general anesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230425057992N1
Registration date:2023-05-16, 1402/02/26
Registration timing:registered_while_recruiting
Last update:2023-05-16, 1402/02/26
Update count:0
Registration date
2023-05-16, 1402/02/26
Registrant information
Name
Seyede zahra Seyf
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4496 5783
Email address
zahra.seyf7596@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-05-31, 1402/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of two combined drug regimens of venous ketorolac and diclofenac suppository in comparison with venous ketorolac alone on reducing pain after abdominal surgery under general anesthesia
Public title
Comparison of the effectiveness of ketorolac and diclofenac on reducing pain after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years, undergoing all kinds of elective surgeries of the abdominal area under general anesthesia, anesthesia class one and two
Exclusion criteria:
1- Existence of any disease limiting the use of NSAID (patients with gastrointestinal, liver, kidney disorders)
2- Incidence of surgery and anesthesia complications
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
This study requires 44 patients to be divided into two groups and 22 patients will be placed in each group. For this purpose, the table of random numbers has been used as follows:
In the table of random numbers, a number is chosen randomly with the eyes closed and by shaking the tip of the pen. Then this number is the starting point, and from this number numbers are recorded from the bottom to the top and assigned to different groups. It should be noted that the selected numbers must be two digits and smaller equal to 44.Then the first 22 numbers that were selected are assigned to group A and the next 22 numbers to group B. On the other hand, the patients undergoing surgery are numbered from 1 to 44 from the beginning of the sampling process, and according to the numbers assigned to them, they are in the subgroup A and B are placed. For group A, intravenous ketorolac drug regimen is used along with diclofenac suppositories, and for group B, intravenous ketorolac drug regimen is used alone.
Blinding (investigator's opinion)
Double blinded
Blinding description
The meaning of double-blind is that neither the surgeon nor the patients will know about the randomization method and treatment protocol taken into consideration.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Islamic Azad University of Medical Sciences
Street address
No1, East Payambar Ave, Abazar Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1473673341
Approval date
2022-12-31, 1401/10/10
Ethics committee reference number
IR.IAU.TMU.REC.1401.282
Health conditions studied
1
Description of health condition studied
Pain reduction after abdominal surgery with general anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Type of medicine, pain intensity, sex, age, type of surgery
Timepoint
Recovery, the first 6 hours and the first 12 hours after the operation
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: In this double-blind randomized clinical trial study, patients undergoing elective abdominal surgery with general anesthesia who are in anesthesia class 1 and 2 were interviewed before surgery and background information including gender, age, clinical and medication records were obtained from them. The question is recorded in the study checklist. After complete preparation, placement of intravenous line, monitoring and receiving oxygen for 3 to 5 minutes with premedication of midazolam 2 mg and fentanyl 2 cc and sodium thiopental 5 mg/kg and atracurium 0.5 mg/kg under anesthesia induction. They are placed and then anesthesia is administered with N2O gas and isoflurane oxygen and repetition of fentanyl and atracurium. At the end of the operation and randomly using a random table of numbers, the patients are evaluated in two groups. The first group receives diclofenac suppositories (100 mg each) and Ketorolac ampoules (15 mg) in the form of infusion. Patients will not know about the randomization method and the considered treatment protocol. Pain intensity is measured during the first 6 hours of recovery and the first 12 hours after the operation. In the group with moderate and severe pain, 10 and 20 mg of pethidine is injected, and the consumption of the two groups is compared.
Category
Treatment - Drugs
2
Description
intervention group: In this double-blind randomized clinical trial study, patients undergoing elective abdominal surgery with general anesthesia who are in anesthesia class 1 and 2 were interviewed before surgery and background information including gender, age, clinical and medication records were obtained from them. The question is recorded in the study checklist. After complete preparation, placement of intravenous line, monitoring and receiving oxygen for 3 to 5 minutes with premedication of midazolam 2 mg and fentanyl 2 cc and sodium thiopental 5 mg/kg and atracurium 0.5 mg/kg under anesthesia induction. They are placed and then anesthesia is administered with N2O gas and isoflurane oxygen and repetition of fentanyl and atracurium.At the end of the operation and randomly using a random table of numbers, the patients are evaluated in two groups. The second group receives only Ketorolak ampoules.Patients will not know about the randomization method and the considered treatment protocol. Pain intensity is measured during the first 6 hours of recovery and the first 12 hours after the operation. In the group with moderate and severe pain, 10 and 20 mg of pethidine is injected, and the consumption of the two groups is compared.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospita
Full name of responsible person
Heydar Darvishi
Street address
Shirmohammadi Ave, Nazi abad, Tehran
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6552
Email
Hdarvishi@iauimuic.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehrdad Gholamzad
Street address
Goleyakh Ave, Shariati Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Int.affairs@tms.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Seyede zahra Seyf
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 1, East Payambar Ave, Abazar Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1473673341
Phone
+98 21 4496 5783
Fax
Email
zahra.seyf7596@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyede zahra Seyf
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 1, East Payambar Ave, Abazar Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1473673341
Phone
+98 21 4496 5783
Fax
Email
zahra.seyf7596@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyede zahra Seyf
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 1, East Payambar Ave, Abazar Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1473673341
Phone
+98 21 4496 5783
Fax
Email
zahra.seyf7596@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD