This Randomized Clinical Trail (RCT) study investigates the effects of injection of Ketamine and Lidocaine prior to surgery in reducing pain of post surgery of tonsillectomy. The participants are candidates of tonsillectomy, referring to Emam Khomeini Hospital of Ardabil. The participants will be randomly assigned into one of following three groups to receive either an injection of 1 mg/kg Ketamine or Lidocaine in the intervention group and the same amount of normal saline in the control group. The intensity of pain and comfort will be evaluated with Chops’ test and Wilson’s test respectively, and Ocher pain will be evaluated by an anesthesiologist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903044027N1
Registration date:2010-09-30, 1389/07/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-30, 1389/07/08
Registrant information
Name
Akbar Pirzadeh
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1551 0060
Email address
a.pirzadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2010-04-20, 1389/01/31
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of peritonsillar infiltration of ketamin and lidocaien for post operative pain relief in children following tonsillectomy
Public title
Effect of peritonsillar infiltration of ketamin and lidocaien for post operative pain relief in children following tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: large tonsil, age between 3 and 15 year
Exclusion criteria: Systematic diseases, hematologic diseases
Age
From 3 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Ardabil University of Medical Sciences
Street address
Ardabil
City
Ardabil
Postal code
Approval date
empty
Ethics committee reference number
6-7
Health conditions studied
1
Description of health condition studied
Tonsillar hypertrophy
ICD-10 code
J35.1
ICD-10 code description
Hypertrophy of tonsils
Primary outcomes
1
Description
Pain
Timepoint
15 and 30 minutes and 1, 2, 4, 6, 8, 16, and 24 hours postoperation
Method of measurement
Vilson and Choobs test
Secondary outcomes
empty
Intervention groups
1
Description
Under general anesthesia five minutes before surgery 0.1 mg/kg lidocain will be injected into peritonsilar area
Category
Treatment - Drugs
2
Description
Under general anesthesia five minutes before surgery 0.1 mg/kg ketamin will be injected into peritonsilar area
Category
Treatment - Drugs
3
Description
Under general anesthesia five minutes before surgery 2 cc water [control] will be injected into peritonsilar area
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabil University of Medical Sciences
Full name of responsible person
Akbar Pirzadeh
Street address
Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Mirzarahimi
Street address
Ardabil University of Medical Sciences
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Akbar Pirzadeh
Position
Otolaringologist
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 1551 0060
Fax
+98 45 1551 0057
Email
a.pirzadeh@arums.ac.ir
Web page address
www.arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Akbar Pirzadeh
Position
Otolaryngologist
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 1551 0060
Fax
+98 45 1551 0057
Email
a.pirzadeh@arums.ac.ir
Web page address
www.arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Akbar Pirzadeh
Position
Otolaryngologist
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 1551 0060
Fax
+98 45 1551 0057
Email
a.pirzadeh@arums.ac.ir
Web page address
www.arums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)