Comparison of the effect of diclofenac and ketorolac drugs orally after impacted wisdom tooth surgery on pain relief
Design
Clinical trial without control group, With intervention groups only, Randomized,
Phase 2 on 52 patients, A table of random numbers is used for randomization.
Settings and conduct
This study will be performed on 52 patients in the maxillofacial surgery department of Ahwaz Dental School, Written consent is obtained from patients before the study, The impacted wisdom teeth are mesiangular or according to the Pell & Gregory classification, Patients will be divided into two equal groups of 26 based on a series of random numbers. Patients in group A will receive ketorolac 10 mg tablets orally and patients in group B will receive Diclofenac 25 mg tablets orally, and the drugs will be given 1 hour before surgery.The visual analog scale is used to assess postoperative pain by telephone on the day of surgery and on the second, third and seventh day after surgery.This study lacks blinding.
Participants/Inclusion and exclusion criteria
Written consent is obtained from patients prior to the study. Inclusion criteria, patients without systemic disease and non-regular use of medication ؛ Exclusion criteria, patients with contraindications to NSAIDs such as allergies, asthmatic patients, pregnant or lactating.
Intervention groups
Patients will be divided into two equal groups of 26 based on a series of random numbers. Patients in group A will receive 25 mg diclofenac and patients in group B will receive 10 mg of ketorolac, and the drugs will be given orally 1 hour before surgery.
Main outcome variables
Measurement of patients' pain during the study period with drug treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220116053738N1
Registration date:2022-04-11, 1401/01/22
Registration timing:registered_while_recruiting
Last update:2022-04-11, 1401/01/22
Update count:0
Registration date
2022-04-11, 1401/01/22
Registrant information
Name
Zahra Hatami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 542 3859
Email address
hatami.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-11, 1401/01/22
Expected recruitment end date
2022-05-05, 1401/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative evaluation of preemptive analgesic effect of diclofenac and ketorolac in oral form after third molar surgery
Public title
Evaluation of analgesics after impacted wisdom tooth surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with systemic health
Exclusion criteria:
Patients with contraindications to non steroidal anti-inflammatory drugs such as allergies, asthma patients, pregnant or lactating patients are excluded from the study
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization is performed using a table of random numbers. To use the table, first the method of reading the table numbers is determined and then the numbers are intended for study groups and is recorded . for example, even numbers are considered for intervention A and odd numbers are considered for intervention B. These sequences are created using SAS software and studied based on them .
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی اهواز
Street address
Nazanin Residential Complex, Shahrivar St, between Dey and Bahman St. Golestan neighborhood, Ahwaz
City
Ahvaz
Province
Khouzestan
Postal code
6136746746799
Approval date
2021-10-31, 1400/08/09
Ethics committee reference number
IR.AJUMS.REC.1400.467
Health conditions studied
1
Description of health condition studied
Comparison of the effect of diclofenac and ketorolac on pain relief after surgery
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
Measurement of pain after impacted wisdom tooth surgery with drug treatment
Timepoint
In the study "Measuring the amount of pain after impacted wisdom tooth surgery with medication", the amount of pain is measured on the first day of surgery and 2, 3, 7 days after taking the drug.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1:The members of this group use 10 mg orall Ketorolac tablets of Abu Reihan company one hour before the surgery. and then how to take the pills, once every 6 hours , The duration of this study is 7 days .
Category
Treatment - Surgery
2
Description
Intervention group 2:The members of this group use 25 ml oral diclofenac tablets of Abu Reihan company one hour before the surgery. and then how to take the tablets, once every 6 hours .In total, and then how to take the pills once every 6 hours ,The duration of this study is 7 days.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Dental School
Full name of responsible person
Dr Mahdis MasoudRad
Street address
Dental School، Dey Ave ،Golestan Town
City
Ahwaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5170
Fax
+98 61 3320 5320
Email
dental-research@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Golestan، valiasr St، Ahvaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Hatami
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Nazanin Residential Complex, Shahrivar St, between Dey and Bahman St. Golestan neighborhood, Ahwaz
City
Ahvaz
Province
Khouzestan
Postal code
6136746799
Phone
098 61 3320 5170
Email
zahrahatami1997@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mahdis Masoud Rad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School، Dey Ave، Golestan Town
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5170
Email
mahdis.mr@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Hatami
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Nazanin Residential Complex, Shahrivar St, between Dey and Bahman St. Golestan neighborhood, Ahwaz
City
Ahvaz
Province
Khouzestan
Postal code
6136746799
Phone
+98 61 3320 5170
Email
zahrahatami1997@gmail.com
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
Undecided - It is not yet known if there will be 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
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
Title and more details about the data/document
Part of the data, such as information about the main outcome, can be shared.
When the data will become available and for how long
Access starts 3 months after the results are published.
To whom data/document is available
Only for researcher working in academic and scientific institutions
Under which criteria data/document could be used
There are no conditions and all colleagues can use all the data
From where data/document is obtainable
Dr Zahra hatami
phone number 09165423859
Email address zahrahatami1997@gmail.com
What processes are involved for a request to access data/document
Finally one week after requesting data or documentation