Introduction: NSAIDs such as Ibuprofen are the most commonly used drugs for pain relief after impacted third molar surgery. Recently, new generation of these drugs have been introduced that act more selectively and have lower gastrointestinal side effects. As to our knowledge there are not enough studies about the effectiveness of these drugs, the objective of this study is to compare celecoxib with ibuprofen and acetaminophen codeine.
Materials and Methods: This randomized clinical trial was done on 180 patients from whom attending oral and maxillofacial surgery department of Tehran university. Patients were divided into three groups to use a single dose of Celecoxib 100mg, Ibuprofen 400 mg or Acetaminophen Codeine( Acetaminophen 300mg + codeine 20mg) after surgery. A questionnaire was given to the patients to mark their pain intensity.
Inclusion Criteria: impcated wisdom teeth, healthy medical history, no analgesic consumption in 24hours ago, no drugs addiction, no pregnancy and breastfeeding, no drugs sensitivity( Analgesics ,Non-steroidal anti-inflammatory drug commonly used, Cyclooxygenase-2 inhibitors)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014113020158N1
Registration date:2015-01-08, 1393/10/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-08, 1393/10/18
Registrant information
Name
Mohammad Ebrahimi Saravi
Name of organization / entity
Mazandaran University of Medical Sciences / Dentistry Faculty
Country
Iran (Islamic Republic of)
Phone
+98 11 3321 0830
Email address
mohammadebrahimisaravi@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Celecoxib, Ibuprofen and Acetaminophen Codeine in pain relief after impacted lower third molar surgery
Public title
evaluation of decreasing pain of impacted wisdom teeth
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criterai: impcated wisdom teeth; healthy medical history; no gastrointestinal ulcer treatment in 30days ago; no analgesic consumption in 24hours ago; no drugs addiction; no pregnancy and breastfeeding; no drugs sensitivity( Analgesics ,Non-steroidal anti-inflammatory drug commonly used, Cyclooxygenase-2 inhibitors) ; no nasal polyps; no bronchospasm and angioedema.
Age
From 16 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
tehran university of medical sciences
Street address
enghelab square
City
tehran
Postal code
Approval date
2008-09-22, 1387/07/01
Ethics committee reference number
4693
Health conditions studied
1
Description of health condition studied
pain control
ICD-10 code
Chapter V
ICD-10 code description
F45.4 Persistent somatoform pain disorder
Primary outcomes
1
Description
pain intensity
Timepoint
2,4,6,10,16,24 hours after surgery
Method of measurement
standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
ibuprofen 400 mg 2,4,6,10,16 and 24 hours after impacted wisdom teeth
Category
Treatment - Drugs
2
Description
celecoxib 100 mg 2,4,6,10,16 and 24 hours after impacted wisdom teeth
Category
Treatment - Drugs
3
Description
acetaminophen codeine 320 mg 2,4,6,10,16 and 24 hours after impacted wisdom teeth
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
oromaxillofacial surgery department of dental school of tehran university of medical sciences
Full name of responsible person
mohammad ebrahimi saravi
Street address
khazar BLV
City
sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ebrahimi Saravi
Street address
Khazar BLV
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
mazandaran university of medical sciences
Full name of responsible person
mohammad ebrahimi saravi
Position
Ph.D
Other areas of specialty/work
Street address
khazar blv
City
sari
Postal code
Phone
+98 11 3324 4894
Fax
Email
mohammadebrahimisaravi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
mazandaran university of medical sciences
Full name of responsible person
mohammad ebrahimi saravi
Position
Ph.D
Other areas of specialty/work
Street address
khazar blv
City
sari
Postal code
Phone
+98 11 3324 4894
Fax
Email
mohammadebrahimisaravi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
mazandaran university of medical sciences
Full name of responsible person
mohammad ebrahimi saravi
Position
Ph.D
Other areas of specialty/work
Street address
khazar blv
City
sari
Postal code
Phone
+98 11 3324 4894
Fax
Email
mohammadebrahimisaravi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)