Objective: Comparison of single dose of Paracetamol with single dose of Dexamethasone on postoperative pain of patients undergoing Septoplasty surgery
Design: Single blind clinical trial
Setting: Patients were divided into three groups randomly: A(Paracetamol) and B(Dexamethasone) and C(Normal saline). Anesthesia was induced in both groups equally using Fentanyl 2 micrograms per kilogram, Midazolam 0.06 milligrams per kilogram, Sodium thiopental 5 milligrams per kilogram and Atracorium 0.5 milligrams per kilogram and was maintained with Propofol infusion (50 microgram per kilogram per minute) and Remifentanyl (0.1 microgram per kilogram per minute).
Inclusion criteria: patients with ASA 1 or 2 ; the patients without history of any hepatic and renal disorder; ; without sensitivity to Paracetamol and Corticosteroids; without history of peptic ulcer disease; without history of treatment with Corticosteroids or other immunosuppressive drugs; without history of DM I and II; no drug abuse Exclusion criteria: patients with perioperative hemodynamic instability ; perioperative respiratory distress; perioperative nausea and vomiting or any important adverse effects .
Intervention: Group A received Paracetamol 1 gram in 100 milliliter normal saline and because of reduction in analgesic effect of dexamethasone if be diluted in 100 milliliter normal saline and because our study was single blind Group B received 0.1 milligram per kilogram Dexamethasone IV up to 8 milligrams in 10 milliliter normal saline and group C received 100 milliliter Normal saline in 15 minute after induction.
Main outcomes: Pain score by VAS at 0 (after extubation), 2, 6, 12 and 24 hours after the end of surgery and Meperidine consumption in 24 hours after surger and any adverse effects were evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012712296N1
Registration date:2013-02-06, 1391/11/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-06, 1391/11/18
Registrant information
Name
Amin Mehrakizadeh
Name of organization / entity
Ahvaz Jondishapour University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 1338 3767
Email address
mehrakizadeh.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Ahvaz Jondishapour University of Medical Science
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of single dose of Paracetamol with single dose of Dexamethasone on postoperative pain of patients undergoing Septoplasty surgery
Public title
The effect of intraoperative administration of IV Paracetamol and Dexamethasone on post operative pain of patient undergoing general anesthesia forSeptoplasty surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with ASA 1 or 2 ; the patients without history of any hepatic and renal disorder; without sensitivity to Paracetamol and Corticosteroids; without history of peptic ulcer disease; without history of treatment with Corticosteroids or other immunosuppressive drugs; without history of DM I and II; no drug abuse Exclusion criteria: patients with perioperative hemodynamic instability ; perioperative respiratory distress; perioperative nausea and vomiting or any important adverse effects .
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jondishapour University of Medical Sciences
Street address
Jondishapour University Center, Golestan Boulevard
City
Ahvaz
Postal code
5555555555
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
ETH-567
Health conditions studied
1
Description of health condition studied
Postoperative Pain
ICD-10 code
R52.0
ICD-10 code description
Acute Pain
Primary outcomes
1
Description
Pain score
Timepoint
0 (after extubation), 2, 6, 12 and 24 hours after surgery
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Incidence of adverse effects
Timepoint
In 24 hours after surgery
Method of measurement
Asking from patients
2
Description
Meperidine consumption
Timepoint
In 24 hours after surgery
Method of measurement
milligramms
Intervention groups
1
Description
After induction Paracetamol 1 gram in 100 milligrams normal saline in 15 minutes
Category
Treatment - Drugs
2
Description
After induction 0.1 milligram per kilogram up to 8 milligrams Dexamethasone IV in 10 milliliter normal saline in 15 minutes
Category
Treatment - Drugs
3
Description
After induction 100 milliliter normal saline in 15 minutes
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Emam Khomeini General Operation Room
Full name of responsible person
Narges Asadi
Street address
Emam Khomeini Hospital, 20 meter Street
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Feghi Mostafa
Street address
Vice chancellor for research, University center, Golestan Boulevard
City
Ahvaz
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 Ahvaz Jondishapour 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
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Amin Mehrakizadeh
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology department, Emam Khomeini Hospital, 20 meter street
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
Email
aminmehrakizadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Amin Mehrakizadeh
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology department, Emam Khomeini Hospital, 20 meter street
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
Email
aminmehrakizadeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Amin Mehrakizadeh
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology department, Emam Khomeini Hospital, 20 meter street
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
Email
aminmehrakizadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)