It is clear that tooth extraction is painful. Our purpose is to compare the effects of acetaminophen, ibuprofen and combination of them in relieving the teeth pain due to extraction under local anesthesia.
In this randomized clinical trial, 105 children (6-11 years old) referred to pediatrics ward of dental faculty of Hamadan University, after taking a testimonial from their parents and taking a history and weighing them, randomly allocated to three groups of 35. Group I received acetaminophen syrup with dose of 15mg/kg. Group 2 received ibuprofen syrup with dose of 5 mg/kg and group 3 received acetaminophen syrup with dose of 7.5mg/kg and ibuprofen syrup with dose of 2.5mg/kg. These children randomly pick out one of the paper written in advance. One hour before and 15 min after tooth extraction, amount of their pain are evaluated according to table (CHEOPS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103123109N2
Registration date:2011-04-21, 1390/02/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-21, 1390/02/01
Registrant information
Name
Fatemeh Zeraati
Name of organization / entity
Hamadan Medical University
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6295
Email address
zeraati@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan Medical University
Expected recruitment start date
2008-08-22, 1387/06/01
Expected recruitment end date
2009-08-23, 1388/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study of Acetaminophen, Ibuprofen and Combination Effects for Pain Relief Following Tooth Extraction in Children under Local Anesthesia
Public title
pain reduction in dentistry
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 6-11 years old, referred to dental clinic for first time, the mooler tooth must be extracted
Exclusion criteria : any disease such as asthma, hypersensitivity or allergy to drugs
Age
From 6 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committee of Hamadan University of Medical Sciences
Street address
Hamadan Medical University
City
Hamadan
Postal code
Approval date
2008-05-19, 1387/02/30
Ethics committee reference number
16/35/9/27510
Health conditions studied
1
Description of health condition studied
teeth pain due to extraction
ICD-10 code
Y45
ICD-10 code description
Analgesic,antipyretic and antiinflammatory drugs
Primary outcomes
1
Description
pain
Timepoint
0 and 15 min after tooth extraction
Method of measurement
Children’s Hospital of Eastern Ontario Pain Scale(CHEOPS)
Secondary outcomes
empty
Intervention groups
1
Description
group 1 received acetaminophen syrup 15mg/kg one hour before tooth extraction
Category
Treatment - Drugs
2
Description
Group 2 received ibuprofen syrup 5mg/kg one hour before tooth extraction
Category
Treatment - Drugs
3
Description
Group 3 received acetaminophen 7.5 mg/kgand ibuprofen syrup 2.5mg/kg one hour before tooth extraction
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadanl University of Medical Science
Full name of responsible person
Street address
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Dr Ghaleiha
Street address
Medical School, Deputy dean for Research
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Science
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
Hamadan University of Medical Sciences
Full name of responsible person
Fatemeh Zeraati
Position
Associated professor
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences,Medical School,Pharmacology Department,
City
Hamadan
Postal code
Phone
+98 81182762957 ext. 206
Fax
Email
zeraati@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Zoya Pahlevani
Position
Dentist
Other areas of specialty/work
Street address
Hamadan university Dental School
City
Hamadan
Postal code
Phone
+98 81182762957
Fax
Email
zoyapah@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Zeraati Fatemeh
Position
Associated professor
Other areas of specialty/work
Street address
pharmacology department In Medical School
City
Hamadan
Postal code
Phone
+98 81182762957 ext. 206
Fax
Email
zeraati@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)