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Determination of Dexamethasone Effects on Postoperative Pain, Nausea and Vomiting, Bleeding, Odynophagia, Voice change, Halitosis, Otalgia after Tonsillectomy in Children Aged 4 to 10 Years

Protocol summary

Summary
Aim of the study: Determination the effect of dexamethasone on postoperative pain, nausea and vomiting, bleeding, odynophagia, voice change, halitosis, otalgia after tonsillectomy in children Key Inclusion Criteria: 4 to 10 years old candidate patients for tonsilectomy Key Exclusion Criteria: Children were excluded if they had a history of convulsion, prematurity, allergy or hypersensitivity to dexamethasone, syndromic disease (e.g. Down syndrome), coagulation disorder, systemic disease, developmental problems, congenital heart disease, nutritional deficiencies like SDP, G6PDand patient with poor follow up. Study Population: One hundred candidate patients aged 4 to 10 years for adenotonsilectomy surgery. Random division: 50 patients in interventional group, 50 patients in control group. Study Intervention: In interventional group: using dexamethasone 0.1 mg/kg after adenotonsilectomy (in ward), in control group: using ringer serum after adenotonsilectomy (in ward) Primary outcome: Evaluation of bleeding, nausea and vomiting, odynophagia, voice change 1 day and during 7 days after surgery and evaluation of acetaminophen intake, halitosis and otalgia during 7 days after surgery by physical examination and questionnaires

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015080522889N2
Registration date: 2015-09-09, 1394/06/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-09, 1394/06/18
Registrant information
Name
Saeid Pourseirafi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 681 2273
Email address
pourseirafi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-12-21, 1390/09/30
Expected recruitment end date
2013-02-18, 1391/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of Dexamethasone Effects on Postoperative Pain, Nausea and Vomiting, Bleeding, Odynophagia, Voice change, Halitosis, Otalgia after Tonsillectomy in Children Aged 4 to 10 Years
Public title
Advantages and Disadvantages of Dexamethasone Administration after Tonsillectomy in Children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 4 to 10 years old children candidate for adenotonsilectomy in Khalili hospital between February 2011 and March 2013; Completing consent form; Completing demographic information and questionnaire Exclusion criteria: Patient’s with history of convulsion; prematurity; allergy or hypersensitivity to dexamethasone; syndromic disease (e.g. Down syndrome) ; coagulation disorder; systemic disease; developmental problems; congenital heart disease; nutritional deficiencies like SDP and G6PD; patient with poor follow up.
Age
From 4 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
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
Shiraz University of Medical Sciences
Street address
Medical college, Imam Hossein square, Zand street,Shiraz
City
Shiraz
Postal code
7134845794
Approval date
2015-08-19, 1394/05/28
Ethics committee reference number
ir.sums.rec.1394.100

Health conditions studied

1

Description of health condition studied
Hypertrophy of tonsils and adenoids
ICD-10 code
J35.8
ICD-10 code description
Hypertrophy of tonsils with hypertrophy of adenoids

Primary outcomes

1

Description
bleeding
Timepoint
1 day and during 7 days after surgery
Method of measurement
physical examination and questionnaire

2

Description
nausea and vomiting
Timepoint
1 day and during 7 days after surgery
Method of measurement
physical examination and questionnaire

3

Description
odynophagia
Timepoint
1 day and during 7 days after surgery
Method of measurement
physical examination and questionnaire

4

Description
voice change
Timepoint
1 day and during 7 days after surgery
Method of measurement
physical examination and questionnaire

5

Description
acetaminophen intake
Timepoint
during 7 days after surgery
Method of measurement
physical examination and questionnaire

6

Description
halitosis
Timepoint
during 7 days after surgery
Method of measurement
physical examination and questionnaire

7

Description
otalgia
Timepoint
during 7 days after surgery
Method of measurement
physical examination and questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In interventional group: using dexamethasone 0.1 mg/kg after adenotonsilectomy (in ward)
Category
Treatment - Drugs

2

Description
In control group: using ringer serum after adenotonsilectomy (in ward)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Dr.Saeid Pourseirafi
Street address
Khalili hospital, Khalili street, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Reza Kaboodkhani
Street address
Medical College, Imam Hossein square, Zand street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Saeid Pourseirafi
Position
ENT resident
Other areas of specialty/work
Street address
ENT Department, Shiraz University of Medical Sciences
City
Shiraz
Postal code
7193616641
Phone
+98 31 4524 8966
Fax
Email
dr.s.pourseirafi@gmail.compourseirafi@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Saeid Pourseirafi
Position
ENT resident
Other areas of specialty/work
Street address
ENT Department, Shiraz University of Medical Sciences
City
Shiraz
Postal code
7193616641
Phone
+98 31 4524 8966
Fax
Email
dr.s.pourseirafi@gmail.compourseirafi@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
ENT Department, Shiraz University of Medical Sciences
Full name of responsible person
Dr.Saeid Pourseirafi
Position
ENT resident
Other areas of specialty/work
Street address
ENT Department, Shiraz University of Medical Sciences
City
Shiraz
Postal code
7193616641
Phone
+98 31 4524 8966
Fax
Email
dr.s.pourseirafi@gmail.compourseirafi@sums.ac.ir
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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