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Evaluation of the premedication effect of Ketorolac compared to Ibuprofen in pain control after mandibular third molar surgery: a randomized clinical trial

Protocol summary

Study aim
Determining the effect of ketorolac premedication compared to ibuprofen in pain control after mandibular third molar surgery
Design
Randomized clinical efficacy, with parallel groups intervention group and control group, phase 3 study on 78 samples
Settings and conduct
Based on the inclusion criteria, 78 samples of patients requiring mandibular third molar tooth surgery referred to the special clinic of Birjand Faculty of Dentistry are selected; They will be randomly divided into 2 intervention groups and 1 control group. 1 hour before surgery, the first intervention group will be given 400 mg of ibuprofen, the second intervention group will be given 20 mg of ketorolac, and the control group will receive a placebo.Then, using a visual analog scale, the amount of pain is measured in 1, 2, 4, 6, 8, 12, 24 hours.
Participants/Inclusion and exclusion criteria
Entry conditions: indication for mandibular wisdom tooth surgery with mesioangular, horizontal and vertical orientation of Winter classification and class I,II and position A and B of Pell and Gregory classification Conditions of non-entry: prohibition of non-steroidal anti-inflammatory drugs (allergy to them, patients with coronary artery bypass surgery, pregnancy, presence of active peptic ulcer and kidney failure.)
Intervention groups
The first intervention group received 400 mg ibuprofen, the second intervention group received ketorolac 20 mg, and the control group received a placebo.
Main outcome variables
intensity of pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230621058554N1
Registration date: 2024-01-16, 1402/10/26
Registration timing: registered_while_recruiting

Last update: 2024-01-16, 1402/10/26
Update count: 0
Registration date
2024-01-16, 1402/10/26
Registrant information
Name
Narges Gholami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3272 9750
Email address
nargesgholami1378@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-27, 1402/10/06
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the premedication effect of Ketorolac compared to Ibuprofen in pain control after mandibular third molar surgery: a randomized clinical trial
Public title
Effect of ketorolac in wisdom tooth surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Written consent to participate in the research project Indication of mandibular wisdom tooth surgery with mesioangular, horizontal and vertical orientation of Winter and class I, II and position A and B of Pell and Gregory classification Age 18 to 35 years Consciousness, cooperation and ability to use medicine and not to use other analgesic medicine
Exclusion criteria:
Contraindication to the use of non-steroidal anti-inflammatory drugs (allergy to them, patients with coronary artery bypass surgery, pregnancy, presence of active peptic ulcer and kidney failure.) Drug use 1) Indications of mandibular wisdom tooth surgery with distangular and transverse orientation of winter and class III ,position C of Pell and Gregory classification
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be allocated using 6 permutation blocks whose order is generated by R software and with the blockrand command, in fact each block contains two letters A, two letters B and two letters is c.)
Blinding (investigator's opinion)
Double blinded
Blinding description
A person outside the study codes the capsules and a code is assigned to each patient. Until the end of the study, the researcher and the participant in the study will not know which category they are in.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Birjand University of Medical Sciences
Street address
Ghafari Ave , Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2023-12-20, 1402/09/29
Ethics committee reference number
IR.BUMS.REC.1402.402

Health conditions studied

1

Description of health condition studied
Mandibular third molar surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
intensity of pain
Timepoint
1,2,4,6,8,12,24 hours after surgery
Method of measurement
via Visual analog scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: receiving a single dose of 400 mg oral ibuprofen tablets from Hakim Pharmaceutical Company (produced in the form of identical capsules under sterile conditions) along with 200 ml of water 1 hour before surgery
Category
Treatment - Drugs

2

Description
Intervention group: receiving a single dose of 20 mg oral ketorolac tablets from Aburihan Pharmaceutical Company (produced in the form of identical capsules under sterile conditions) along with 200 ml of water 1 hour before surgery.
Category
Treatment - Drugs

3

Description
Control group: receiving a single dose of placebo (similar to other capsules produced in sterile conditions) along with 200 ml of water 1 hour before surgery
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Birjand Faculty of Dentistry Special Clinic
Full name of responsible person
Mostafa Alizadeh Abkoh
Street address
Taleghani Ave, Imam Reza Hospital
City
Birjand
Province
South Khorasan
Postal code
1713643135
Phone
+98 56 3223 2734
Email
dent@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tuba Kazemi
Street address
Ghaffari Ave , University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
drtooba.kazemi@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
Mostafa Alizadeh Abkoh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghaffari Street, University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
1713643135
Phone
+98 56 3238 1700
Email
alizadeh_68m@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mostafa Alizadeh Abkoh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghaffari Street, University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
1713643135
Phone
+98 56 3238 1700
Email
alizadeh_68m@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Narges Gholami
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Moalem2
City
Birjand
Province
South Khorasan
Postal code
9771856586
Phone
+98 56 3272 9750
Fax
Email
nargesgholami1378@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
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