Rhinoplastic surgery is one of the most prevalent surgeries and post-surgical pain control is very important. The aim of this study is to compare the prophylactic analgesic effects of acetaminophen and celecoxib in patients undergoing rhinoplastic surgery. In this double blind active controlled clinical trial 70 patients aged 18-40 y/o who candidate for rhinoplasty+ osteotomy and after completion of informed consent form will randomly divided into 2 groups; case group (tab celecoxib 200mg, 30min before operation and every12 hours after first dose till24 hours) and control group (tab acetaminophen 500 mg, 30min before operation and every 6 hours after first dose till 24 hours). Pain severity will be measured immediately before the first dose, 2 hours after surgery and every 6 hours till 24 hours using VAS score (or immediately before drug consumption in concurrency situation). The protocol of general anesthesia will be similar in all patients. History of allergy to medications; unwillingness to participate; severe drugs side effects; underlying disease and alcohol or drug addiction are exclusion criteria. All gathering data will be compared between 2 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102111191N1
Registration date:2013-01-19, 1391/10/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-19, 1391/10/30
Registrant information
Name
Atena Esmaeli
Name of organization / entity
Pharmacy School of Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21886623340
Email address
a.esmaeli@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Shahid Beheshti University of Medical Sciences.
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the prophylactic analgesic effects of acetaminophen and celecoxib in patients undergoing rhinoplasty operation
Public title
Comparison of the prophylactic analgesic effects of acetaminophen and celecoxib in patients undergoing rhinoplasty operation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: functional class I; completed informed consent form Exclusion criteria: history of allergy to acetaminophen or sulfonamides; unwillingness to participate in the study; complications of rhinoplastic surgery; severe drugs side effects; current sever illnesses such as: cardiovascular disease, diabetes mellitus type1, obstructive pulmonary disease and asthma, sever HTN, epilepsy, renal or liver dysfunction, analgesic consumption 12 hours before the surgery, alcohol or drug addiction.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Pharmacy School of Shahid Beheshti University of Medical Sciences, Valiasr St, Tehran.
City
Tehran
Postal code
Approval date
2012-02-05, 1390/11/16
Ethics committee reference number
90-11-16
Health conditions studied
1
Description of health condition studied
post surgical pain
ICD-10 code
Z42.0
ICD-10 code description
Follow-up care involving plastic surgery of head and neck
Primary outcomes
1
Description
Pain severity
Timepoint
before operation, 2hours after rhinoplasty, every 6 hour till 24 hours
Method of measurement
Visual Analogue Scale(VAS)
2
Description
Requested analgesic dose
Timepoint
first 24 hours
Method of measurement
mg
Secondary outcomes
1
Description
Surgical site bleeding
Timepoint
first 24 hours
Method of measurement
Observation
Intervention groups
1
Description
Intervention: Tab Celecoxib 200 mg, 30min before operation, every 12 hour in first 24 hours
Category
Treatment - Drugs
2
Description
Control group: Tab Acetaminophen 500 mg, 30 min before operation, every 6 hour in first 24 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Jamshid Salamzadeh
Street address
Loghman Hakim Hospital, Makhsus Ave, Kamali Ave, South Kargar Ave, Tehran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Vice Chancellor for Research of Shahid Beheshti University of Medical Sciences, Valiasr St, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Shahid Beheshti 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
Pharmacy School of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atena Esmaeli
Position
Student of Pharmacology
Other areas of specialty/work
Street address
Pharmacy School of Shahid Beheshti University of Medical Sciences,Valiasr St, Tehran
City
Tehran
Postal code
Phone
+98 21 8866 2340
Fax
Email
a.esmaeli@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pharmacy School of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jamshid Salamzadeh
Position
Clinical Pharmacologist
Other areas of specialty/work
Street address
Pharmacy School of Shahid Beheshti University of Medical Sciences, Valiasr St, Tehran.
City
Tehran
Postal code
Phone
+98 21 8866 2340
Fax
Email
j.salamzadeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pharmacy School of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atena Esmaeli
Position
Student of Pharmacology
Other areas of specialty/work
Street address
Pharmacy School of Shahid Beheshti University of Medical Sciences, Valiasr St, Tehran.
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)