Effect of Dexamethasone to prevent Propofol injection pain in children 6 to 13 years old in elective surgery Birjand Valiasr hospital and Emamreza hospital in 2016
This randomized, double-blind, controlled with placebo, in order to determine the Effect of Dexamethasone to prevent Propofol injection pain in children 6 to 13 years old in elective surgery Birjand Valiasr hospital and Emamreza hospital in 2016 will be carried out. A study of 50 children undergoing elective surgery done. Inclusion criteria: children aged 6 to 13 years undergoing elective surgery (tonsillectomy, adenotonsillectomy, adenoctomy, lower extremity fractures). Exclusion criteria included children crying when entering the operating room; emergency; abnormal liver and renal function; musculoskeletal disorders and allergy to Propofol; Dexamethasone and also entering an intravenous line in the back of their hand are impossible.
Patients enrolled were randomly assigned to one of two groups, study group and control. In both groups of patients with venous cannula (22) is taken. Under the same conditions to all patients two hours before surgery 0/2 mg Midazolam (oral) as Prymdykyshn and 20 cc juice is prescribed. Then 6 ml per kg intravenous Sugar solution (2 / 3,1 / 3) infusion. At study group 0/15 mcg per kg Dexamethasone and the control group with the same volume of Normal Saline injected. Then induction dose of Propofol 1% to just 20% of all patients, infusion and injection pain by Face Pain Scale (FPS) with rating (0 to 10) is measured and recorded. The remainder of the dose of Propofol and Fentanyl Atracurium injected.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011325992N1
Registration date:2016-02-19, 1394/11/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-19, 1394/11/30
Registrant information
Name
Hossein Hashemi
Name of organization / entity
Anesthesiology
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 7548
Email address
hossein.hashemy93@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-03-29, 1395/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Dexamethasone to prevent Propofol injection pain in children 6 to 13 years old in elective surgery Birjand Valiasr hospital and Emamreza hospital in 2016
Public title
Effect of Dexamethasone to prevent Propofol injection pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children ages 6 to 13 years undergoing elective surgery (tonsillectomy, adenotonsillectomy, adenoctomy, lower extremity fractures).
Exclusion criteria: included children crying when entering the operating room; emergency; abnormal liver and renal function; musculoskeletal disorders and allergy to Propofol, Dexamethasone; and also entering an intravenous line in the back of their hand are impossible.
Age
From 6 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand University of Medical Sciences
Street address
Birjand, Birjand University of Medical Sciences.
City
Birjand
Postal code
Approval date
2015-10-04, 1394/07/12
Ethics committee reference number
ir.bums.1394.45
Health conditions studied
1
Description of health condition studied
Propofol injection pain
ICD-10 code
R52
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
Facial expressions child
Timepoint
Immediatly after the injection 20% of the doss of Propofol anesthesia
Method of measurement
Face Pain Scale (FPS) with rating (0 to 10)
2
Description
Heart rate of patient
Timepoint
Before Dexamethasone and Normal Saline injection and after administration of anesthesia Propofol dose by 20%
Method of measurement
In bits per minute using ECG
Secondary outcomes
1
Description
Injection site pain, redness, injection site phlebitis
Timepoint
After transferring the patient to recovery
Method of measurement
Visit the site of injection
Intervention groups
1
Description
Study group: Injection of 0.15 micrograms per kilogram immediately before induction of anesthesia Propofol injection 20% .
Category
Treatment - Drugs
2
Description
Control group: Normal Saline at the same volume confounding medication immediately before induction of anesthesia Propofol infusion dose by 20%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital of Birjand
Full name of responsible person
Dr seyed Hasan Karbasi
Street address
City
Birjand
2
Recruitment center
Name of recruitment center
Vali Asr hospital of Birjand
Full name of responsible person
Dr seyed Hasan Karbasi
Street address
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Asghar Zarban
Street address
Birjand, Birjand University of Medical Sciences.
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?