The pain following tonsillectomy in children is common and due to its problems addressing and removing the pain would be essential. The effect of ketamine has been proved in this field. The objective of this study is to find out the best possible method of applying ketamine with maximum effect and minimum side effects after tonsillectomy. In this double blind, randomized clinical trial, 92 children with the range of 3-9 ages have been studied. At the entry standards for the study included: 1. selective tonsillectomy, 2. children with 3-9 ages, 3. ASAI, II. Meanwhile they did not have contraindication for ketamine and no internal disease. They divided randomly into 2 groups of oral and injection peritonsilar. All the patients were given 2 mg/kg of apple – juice, 30 minutes before surgery. Through which the injection group received apple-juice without ketamine and oral group received the same plus 5 mg/kg Ketamine. In peritonsilar group, 0/5 mg/kg Ketamine was injected around Tonsil and in oral group the same volume was injected around Tonsil 3 minutes before surgery. In this study, pain caused by surgery was studied 6 hours after tonsillectomy by modified scoring CHEOPS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811192080N2
Registration date:2010-03-18, 1388/12/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-03-18, 1388/12/27
Registrant information
Name
Afsaneh Norouzi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 7474
Email address
norouzi.a@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Reserch of Arak University of Medical Siences
Expected recruitment start date
2009-09-29, 1388/07/07
Expected recruitment end date
2010-01-20, 1388/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Oral Ketamine and Its Peritonsillar Injection in Pain Relief and the Related Phenomenon after a Tonsillectomy Operation
Public title
Comparison the Effect of Oral Ketamine and Its Peritonsillar Injection in Pain Relief and the Related Phenomenon after a Tonsillectomy Operation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-age 3-9 years 2-ASAI,II 3-elective tonsillectomy.
Exclusion Criteria: 1-internal disease 2-contraindication for Ketamin (upper respiratory tract infection, increase ICP, open eye surgery, seizure)
Age
From 3 years old to 9 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
92
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
Arak University of Medical Sciences
Street address
Alamol Hoda St.
City
Arak
Postal code
Approval date
1388-07-06, 769/01/-621
Ethics committee reference number
88-60-3
Health conditions studied
1
Description of health condition studied
Tonsillectomy
ICD-10 code
J03.9
ICD-10 code description
Acute tonsillitis, unspecified
Primary outcomes
1
Description
Pain after tonsillectomy
Timepoint
6 hour after tonsillectomy
Method of measurement
modified CHEOPS Score
Secondary outcomes
1
Description
Post operative complication
Timepoint
post operation
Method of measurement
check list
Intervention groups
1
Description
Oral ketamine with apple juice and peritonsillar injection of normal saline
Category
Treatment - Drugs
2
Description
Oral apple juice and peritonsillar injection of ketamine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr. Afsaneh Norouzi
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Siences
Full name of responsible person
Dr. Said Changizi Ashtiyani
Street address
Deputy of Reserch, Arak University of Medical Siences
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Siences
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 Scienses
Full name of responsible person
Dr Afsaneh Norouzi
Position
Assistant Professor , Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital,Arak City,Markazi State
City
Arak
Postal code
Phone
+98 86122247900
Fax
+98 86 1328 9756
Email
norouzi.a@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Scienses
Full name of responsible person
Dr. Afsaneh Norouzi
Position
Assistant professor , Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital
City
Arak
Postal code
Phone
+98 86 1224 7900
Fax
+98 86 1328 9756
Email
norouzi.a@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University Medical Scinses
Full name of responsible person
Maryam Ghadimi
Position
Medical Student
Other areas of specialty/work
Street address
City
Arak
Postal code
Phone
+98 86 1325 5268
Fax
+98 86 1328 9756
Email
Maryam_Ghadimi2005@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)