Evaluation the effect of Novafen prescription versus combination of Acetaminophen codeine and Ibuprofen on pain after surgical extraction of wisdom teeth
objective: to determine a standard protocol for pain control after wisdom teeth surgeries.
Inclusion criteria:1. age between 18-30 2.physical status ASA 1,2
Exclusion criteria:allergy and systemic diseases
the randomized double blind controled clinical trial on 80 patients who reffered to kerman dental school,oral and maxillofacial surger deparment is performed in 2014 .
2 groups of 40 patients selected randomy from men and women who candidate for third molar surgery, acoording to date of admitting.2 groups were similar in age ,sex and difficulty of surgery.after filling the consent form and performing surgery ,one group recieved 20 tablets of novafen and placebo and another group recieved 20 tablets of acetaminophen codein and ibubrofen 200.but the patient and surgeon dont know the drug.patients recieve codes,then they complete the pain 3,6,12,24,48 hours after surgery according to VAS (visual analog scale) scales.then the data would be statically analyzed.patients can quit this study if they would not want want to follow the protocols
sample size: with a=0.05 and B=0.1,the sample size was 40 for each group
interventions:analgesis drugs novafen and acetaninophen cod and ibubrofen
outcome:analgesia
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014091919228N1
Registration date:2014-12-19, 1393/09/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-19, 1393/09/28
Registrant information
Name
Sahand Samieirad
Name of organization / entity
Oral & maxillofacial surgery ward,oral & dental research center,kerman dental university, Iran
Country
Iran (Islamic Republic of)
Phone
+98 912 813 7859
Email address
sahand@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman Dental and Oral disease research center, Kerman University of Medical Sciences.
Expected recruitment start date
2014-12-11, 1393/09/20
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Novafen prescription versus combination of Acetaminophen codeine and Ibuprofen on pain after surgical extraction of wisdom teeth
Public title
Evaluation the prescription effect of Novafen versus combination of Acetaminophen codeine and Ibuprofen on pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1. age between 18-30 2.physical status ASA 1,2 3.without analgesic use history 4.without oral and maxillofacial surgery history 5.without oral and maxillofacial trauma history 6.having one mesioangular lower third molar with pell & gregory class I ,A 7.without previous wisdom teeth surgery 8.without using alcohol and narcotics 9.without asthma history 10.without gastic ulcer and GI bleeding
Exclusion criteria:
1.oral and maxillofacial surgery and admission history 2.having any chronic systemic or psychosomatic disease 3.having history or risk of infective endocardititis 4.having bleeding disease or using anticoagulant drugs like asorin
5.using alcohol and narcotics 6.acute local infection 7.allergy to codein or cafeine
8.pregnancy or lactating period
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
dental and oral disease center,kerman university of medical sciences
Street address
kerman,jomhoori blv,shafa st
City
kerman
Postal code
76175
Approval date
2014-12-02, 1393/09/11
Ethics committee reference number
۲۸/ ع
Health conditions studied
1
Description of health condition studied
impacted teeth
ICD-10 code
k01.1
ICD-10 code description
An impacted tooth is a tooth that has failed to erupt because of obstruction by another tooth.