The objective of this study is evaluation of efficacy of dexamethasone on decreasing pain after tonsilectomy. A total of 200 Patients aged 18 years or younger assigned into one of the two intervention groups. The patients who contraindicate for take corticosteroid are excluded from the study. The patients in the intervention group receive two doses of dexamethasone, 0.5 m/kg each, while those in the control group receive normal saline with the same volume of calculated doses of dexamethasone during and 8 hours after tonsilectomy. The intensity of pain after tonsilectomy is measured by pain scoring scale in the first and fifth days after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104216213N2
Registration date:2011-06-30, 1390/04/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-30, 1390/04/09
Registrant information
Name
Neda Salehjafari
Name of organization / entity
Arak University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 6862
Email address
nedasalehjafari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Arak University of Medical Sciences
Expected recruitment start date
2011-06-06, 1390/03/16
Expected recruitment end date
2011-06-06, 1390/03/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effect of dexamethasone on post-tonsilectomy pain in Amirkabir hospital
Public title
The effect of dexamethasone on post-tonsilectomy pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: candidate for tonsillectomy due to tonsilar hypertrophy, recurrent tonsillitis, or pre-tonsilar abcess
Exclusion criteria: receiving corticosteroids (for example hyper-reactive airway), contraindicate for corticosteroid prescription (for example diabetes, cushing/suspected to TB)
Age
To 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy Research of Arak University of Medical Sciences
Street address
Deputy of Research - Pardis University Site - Basij Square
City
Arak
Postal code
Approval date
2010-06-30, 1389/04/09
Ethics committee reference number
89-91-2
Health conditions studied
1
Description of health condition studied
pain after tonsilectomy
ICD-10 code
T88
ICD-10 code description
Complications of surgical and medical care, not elsewhere classified
Primary outcomes
1
Description
Dcreasing pain after tonsilectomy
Timepoint
First and fifth days after tonsilectomy
Method of measurement
By using pain scoring scale
Secondary outcomes
empty
Intervention groups
1
Description
Control Group: Normal Saline twice (During tonsilectomy and 8 hours after the surgery), 0.125 ml/kg, IV
Category
Placebo
2
Description
Intervention Group: Dexamethasone (During tonsilectomy and 8 hours after surgery), 0.5 ml/kg, IV
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Depuy Research of Arak University of Medical Science
Full name of responsible person
Dr. Saeed Changizi Ashtiani
Street address
Deputy Research-Pardis University Site-Basij Square
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Depuy Research of Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Neda Salehjafari
Position
Specialist Phisician(Ear,Nose,Throat)-Assistant Professor
Other areas of specialty/work
Street address
ENT Department-Amirkabir Hospital-Parastar Square
City
Arak
Postal code
Phone
+98 86 1313 5077
Fax
Email
nedasalehjafari@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Neda Salehjafari
Position
Specialist Phisician (Ear.Nose,Throat Specialist)-Assitant Professor
Other areas of specialty/work
Street address
ENT Department-Amirkabir Hospital-Parastar Square
City
Arak
Postal code
Phone
+98 86 1313 5077
Fax
Email
nedasalehjafari@arakmu .ac ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Farzad Zamani Barsari
Position
Specialist Phisician(ENT)-Assistant Professor
Other areas of specialty/work
Street address
ENT Department-Amirkabir Hospital-Parastar Square
City
Arak
Postal code
Phone
+98 86 1223 0155
Fax
Email
farzamani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)