The effect of acetaminophen on pain and outcome of close nasal fracture reduction surgery under local anesthesia, compered with placebo
Design
Controlled randomized clinical trial with a triple blinded with 68 sample size
Settings and conduct
Patients with nasal fracture referring to AmirAlam Hospital's nasal fracture clinic will be done in 2018.
The person responsible for the randomization is out of place and is blind to results. The individual who gives the medication to the patients does not know the type of drug.
Patients undergo nasal reduction by a person who is blind to the group in which the patients are located.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age over 18 years;
Proper patient tracking; Satisfaction of the patient with localized anesthesia
Exclusion Criteria: Patient required open reduction; Having uncontrolled cardiovascular disease; Septum fracture; Cartilage fracture; The use of other analgesic in the last 24 hours
Intervention groups
To the intervention group one hour before the start,500 mg Acetaminophen tablet is given and to the control group a pill with the same shape and color and taste is given.For all patients, the anterior ethmoeidal nerve block and infra orbital with a Lidocaine of 2% C are given in two directions, and the cotton-impregnated with diluted Epinephrine (1 in 100,000 units) will be placed inside the Xylocaine in the nasal cavity of the patient.
Main outcome variables
Pain Intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170108031822N2
Registration date:2018-08-15, 1397/05/24
Registration timing:prospective
Last update:2018-08-15, 1397/05/24
Update count:0
Registration date
2018-08-15, 1397/05/24
Registrant information
Name
Kayvan Aghazadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 3037
Email address
aghazadeh@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acetaminophen on pain and outcome of close nasal fracture reduction surgery under local anesthesia,compered with placebo
Public title
The effect of acetaminophen on pain and outcome of close nssal fracture reduction surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Proper follow up patient
Patient satisfaction to reduction under local anesthesia
Exclusion criteria:
Patient needs to open reduction
Having uncontrolled cardiovascular disease
Septum fracture
Use of other sedative in the last 24 hours
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by 4 block size
Blinding (investigator's opinion)
Triple blinded
Blinding description
In the present study doctor, the patient and the analyst will be Blind. This clinical trials study is a triple blind study. It is responsible for the randomization of the person who is out of place and blind to results. Patients are numbered based on the block. Medications will be encoded and the person who gives the drugs to the patients is not known about the type of drugs. Patients are placed under close nasal reduction by a person who blinded to the group in which the patients are located.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Vice chancellor for research, Tehran University of Medical Sciences, Ghods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-08-19, 1396/05/28
Ethics committee reference number
IR.TUMS.VCR.REC.1396.3225
Health conditions studied
1
Description of health condition studied
Nasal bone Fracture
ICD-10 code
S02.2
ICD-10 code description
Fracture of nasal bones
Primary outcomes
1
Description
Pain Intensity
Timepoint
After nasal fracture reduction
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Take 1 tablet of acetaminophen 500 mg one hour before close nasal fracture reduction
Category
Treatment - Drugs
2
Description
Control group: Use of placebo with the same color and shape and taste
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
AmirAlam hospital
Full name of responsible person
Amirhossein Ghabasiah
Street address
North Saadi St, AmirAlam Hospital
City
Tehran
Province
Tehran
Postal code
11457651116
Phone
+98 21 6670 6108
Email
ah.ghabasiah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammadali Sahraeian
Street address
ghods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Email
resdeputy@tums.ac.ir
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
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
Amirhossein Ghabasiah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
North Saadi St, AmirAlam Hospital
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6670 6108
Email
AH.ghabasiah@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Keyvan Aghazadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
North Saadi St, AmirAlam Hospital
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6670 3037
Fax
+98 21 8800 1873
Email
aghazadeh@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirhossein Ghabasiah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
North Saadi St, AmirAlam Hospital
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6670 6108
Email
AH.ghabasiah@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