Determining the effect of Oxycodone in comparison with Acetaminophen codeine on pain control after removal of the grown mandibular third molar.
Design
Randomized, double blinded clinical trial with a parallel group design of 48 patients. Sealed envelopes were used for randomization.
Settings and conduct
Eligible patients were operated on by a surgeon to extract the third erupted mandibular molar. Patients were randomly divided into two groups and the pill was given blindly by the surgeon. The time of receiving the studied analgesics is one hour before the surgery and after observing the first sign of pain.
This trial was performed in the Department of Oral and Maxillofacial Surgery, School of Dentistry, Islamic Azad University of Medical Sciences, Tehran.
Participants/Inclusion and exclusion criteria
Admission requirements:
1. Patients with third erupted molar under the same conditions.
2. Patients in the age range of 17 to 35 years.
No entry conditions:
1. Systemic disease.
2. Menstruation, pregnancy or breastfeeding.
3. Pain in other parts of the body or primary pain in third molar.
4. taking analgesic less than 48 hours before.
5. Taking another analgesic at the same time.
Intervention groups
The intervention group in this study is a group in which patients are given 5 mg of Oxycodone to evaluate the effect of this drug on pain control after extraction of the third molars of the mandible compared to the Acetaminophen codeine 300/20 mg.
Main outcome variables
Pain intensity, Duration of analgesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171216037893N4
Registration date:2021-01-26, 1399/11/07
Registration timing:retrospective
Last update:2021-01-26, 1399/11/07
Update count:0
Registration date
2021-01-26, 1399/11/07
Registrant information
Name
Hamidreza Mahaseni aghdam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 6440
Email address
h_mahaseni@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-08, 1399/09/18
Expected recruitment end date
2021-01-09, 1399/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of oxycodone with Acetaminophen codeine on pain control after erupted mandibular third molar extraction.
Public title
Comparison of the efficacy of Oxycodone with Acetaminophen codeine on pain control after extraction of wisdom teeth.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with erupted mandibular third molar
Age range: 17 to 35 years
Exclusion criteria:
systemic disease
Menstruation, pregnancy and breastfeeding
Pain in other parts of the body or primary toothache
Taking painkillers less than 48 hours before
Take another painkiller at the same time as the medication
Age
From 17 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly considered as both intervention and control groups. Simple random individually with using random numbers. In this way, the referring patients receive the number assigned, the patients receive the even number of drug number 1 and the patients receive the odd number of drug number 2, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher delivers painkillers in sealed bags to the clinical caregiver. Study participants receive an anonymous and sealed analgesic from the clinical caregiver after tooth extraction.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Medical Sciences, Tehran
Street address
Dental College, 9th Neyestan Ave, Pasdaran st.
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2020-12-07, 1399/09/17
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.240
Health conditions studied
1
Description of health condition studied
Extraction of the third erupted mandibular molar
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intensity of pain
Timepoint
After 24 hours
Method of measurement
Visual Analogue Scale
2
Description
Duration of analgesia after taking analgesic
Timepoint
Ffter 24 hours
Method of measurement
the watch
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group takes a dose of 5 mg Oxycodone one hour before surgery and also the next dose after feeling the first pain after tooth extraction.
Category
Treatment - Drugs
2
Description
Control group: This group takes a dose of 300/20 mg Acetaminophen codeine one hour before surgery and also the next dose after feeling the first pain after tooth extraction.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and Maxillofacial Surgery department, School of Dentistry, Islamic Azad University of Medical S
Full name of responsible person
Hamidreza Mahaseni Aghdam
Street address
Dentistry department, 9th Neyestan Ave., Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
hamidmahaseni@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
Dentistry college, 9th Neyestan Ave., Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
hamidmahaseni@gmail.com
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
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
Tehran University of Medical Sciences
Full name of responsible person
Hamidreza Mahaseni Aghdam
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry college, 9th Neyestan Ave., Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
hamidmahaseni@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamidreza Mahaseni Aghdam
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry college, 9th Neyestan Ave., Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
hamidmahaseni@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamidreza Mahaseni Aghdam
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry college, 9th Neyestan Ave., Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
hamidmahaseni@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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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