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A comparison of analgesic effect of Intravenous Acetaminophen (Apotel) versus Oxycodone Tablet and oral Acetaminophen codeine in Rhinoplasty and Septoplasty Surgery

Protocol summary

Summary
Purpose: Determine the efficacy of intravenous acetaminophen, Tab acetaminophen codeine,Tab oxycodone in analgesia after Septorhinoplasty surgery. Methods: Multicenter, double-blind clinical trial,on 75 patients, men and women 18 to 40 years, patients must not have any underlying disease, three groups of 25 each, for all patients will infused 1000 mg intravenous acetaminophen over 20 min in the recovery room after surgery. After 6 h of injection of intravenous acetaminophen, 25 patients will take 2 tablets of acetaminophen codeine 300/10 every 6h, 25 patients will take 2 tablets of oxycodone 5 mg every 8 h, and 25 patients will take 1000 mg intravenous acetaminophen every 8 h, until 24 h, The pain of patients will scale with VAS score every 4 h and vital signs monitoring will be every 4 h.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012062410102N1
Registration date: 2012-12-24, 1391/10/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-12-24, 1391/10/04
Registrant information
Name
Ehsan Bastan hagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4204 6310
Email address
drbastanhagh@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-06-22, 1391/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of analgesic effect of Intravenous Acetaminophen (Apotel) versus Oxycodone Tablet and oral Acetaminophen codeine in Rhinoplasty and Septoplasty Surgery
Public title
Comparing three drugs, apotel, oxycodone and acetaminophen codeine analgesia after nasal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18-40 years; Elective patient for septorhinoplasty sergury; Postoperative pain; Anesthesia without complication. exclusion criteria: Any alergic history with acetaminophen; oxycodone, and codeine; Contraindication for opioids; severe pain with high VAS score; Renal disease with Cr >1.5; Liver disease with LFT >1.5 times; Lung disease ; Coagulopathy ; Pregnancy and lactation; Asthma; Unstable hemodynamic; Anti epileptic agents
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: 75
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
Tehran University of Medical Sciences
Street address
5th flour, Corner of ghods St, Keshavarz Blv.
City
Tehran
Postal code
Approval date
2012-07-01, 1391/04/11
Ethics committee reference number
130/568/د/91

Health conditions studied

1

Description of health condition studied
control of post operative pain
ICD-10 code
Y45
ICD-10 code description
Analgesics, antipyretics and anti-inflammatory drugs

Primary outcomes

1

Description
pain
Timepoint
every 4 hours
Method of measurement
VAS scaling

Secondary outcomes

1

Description
nausa and vomiting
Timepoint
every 4 hours
Method of measurement
asking

Intervention groups

1

Description
Tab Acetaminophen Codeine 310 mg 2 Tab every 6 hours for 24 hours
Category
Treatment - Drugs

2

Description
Tab oxycodone 5 mg 2 Tab every 8 hours for 24 hours
Category
Treatment - Drugs

3

Description
Amp apotel 1000 mg 1 Amp every 8 hours for 24 hours
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Fatemeh Hospital
Full name of responsible person
Ehsan Bastanhagh
Street address
21th St, Yousefabad St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Tehran University of Medical Science
Full name of responsible person
Dr. Akbar Fotouhi
Street address
6th floor, Qods St. Keshavarz Blv.
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 Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Bastanhagh
Position
physician/ Resident
Other areas of specialty/work
Street address
4th floor,Rasol hospital, Niayesh St, Satarkhan St.
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
e-bastanhagh@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical science
Full name of responsible person
Mahmoodreza Alebouye
Position
Assistant Prof.
Other areas of specialty/work
Street address
4th floor, Rasool Hospital, Niayesh St. Satarkhan St.
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
dr.alebouye@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran Uneversity of Medical science
Full name of responsible person
Ehsan Bastanhagh
Position
Physician/ resident
Other areas of specialty/work
Street address
4th floor, Rasool Hospital< Niayesh St, Satarkhan St.
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
e-bastanhagh@razi.tums.ac.irehsanbastanhagh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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