Post tonsillectomy pain management in children remains a problem. Peritonsillar infiltration with tramadol or ketamine (either alone) reported had effective analgesic in other studies. The purpose of this study is to determine which of two drugs is better to pain reduction with less side effects. This randomized double-blinded placebo-controlled clinical trial study perform on 126 patients 5-12 yeas in ASA class I-II, who are candidate for elective bilateral tonsillectomy due to chronic or recurrent tonsillitis. Patients don't have any past history of coexisting disease. After anesthesia induction and tracheal intubation, patients randomly allocate to receive tramadol 2 mg/kg (n = 42) or ketamine 0.5 mg/kg ( n=42) or normal saline ( n=42) in volumes of 2cc, bilateral peritonsillar injection (each side 1 cc) 3 min before surgery. Anesthesia method and surgical technique are same for all patients.Patients don't have post history of coexisting disease.If we have any unexpected problems during study ( excessive bleeding, difficult intubation,...),
patient is excluded of study. After end of surgery and extubation, pain with CHEOPS score is assessed in the recovery room at 10- 20- 30- 40- 60 min post surgery and then in the ward at 2- 4- 6- 8- 12 hours.
Finally we analyze the collected data with using statistical software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103255764N2
Registration date:2011-04-25, 1390/02/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-25, 1390/02/05
Registrant information
Name
Vida Ayatollahi
Name of organization / entity
Shahid Sadughi University
Country
Iran (Islamic Republic of)
Phone
+98 35 1821 5730
Email address
ayatt.vida@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shahid Sadughi Medical University
Expected recruitment start date
2010-05-31, 1389/03/10
Expected recruitment end date
2010-11-11, 1389/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of peritonsillar injection of ketamine with tramadol on the post tonsillectomy pain
Public title
The effects of peritonsillar injection of ketamine or tramadol on the post tonsillectomy pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1); 5-12 yr patients, who are candidate for elective bilateral tonsillectomy due to chronic or recurrent tonsillitis ;
2);ASA class =I,II (American society of anesthesiology);
3) ;No evidence of difficult air way management:
4);Without cardio, pulmonary, endocrine, psycho and metabolic disease;
5);Do not use analgesic drugs in the last 24 hours;
6);No electrolyte abnormalities;
7);No tonsillectomy indication except chronic or recurrent tonsillitis;
8);No mental, cerebral and growth problems;
9);No sore throat
Exclusion criteria:
1) ;surgery time > 1 hour;
2) ;History of reaction to drugs studies;
3) ;Unexpected problems during anesthesia and surgery (excessive bleeding, difficult intubation,...);
4) ;Cauterization that used during surgery
Age
From 5 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
126
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
Ethics committee of Medical Sciences and Health Services Shaid Sadoughi university
Street address
Bahonar square
City
Yazd
Postal code
Approval date
2009-06-14, 1388/03/24
Ethics committee reference number
24430
Health conditions studied
1
Description of health condition studied
ٍEffect of tramadol on post tonsillectomy pain
ICD-10 code
Y45.0
ICD-10 code description
Opioids and related analgesics
2
Description of health condition studied
Effect of ketamine on the post tonsillectomy pain
ICD-10 code
Y48.2
ICD-10 code description
Other and unspecified general anaesthetics
Primary outcomes
1
Description
Post-tonsillectomy pain
Timepoint
Each 10 min in the recovery room until 1 hour. Then each 2 hour until 12 hour in the ward.
Method of measurement
;CHEOPS score;
Secondary outcomes
1
Description
Sedation
Timepoint
2- 4- 6- 8- 12 hours post interance to ward
Method of measurement
RAMSY score
2
Description
Systolic, diastolic, mean blood pressure
Timepoint
Each 5 min during surgery, 5- 10 - 15- 30- 60 min in the recovery
Method of measurement
Non invasive blood pressure
3
Description
Negative Behaviors and hallucination
Timepoint
In the recovery room
Method of measurement
Visual
4
Description
Heart rate
Timepoint
Each 5 min during surgery, 5- 10 - 15- 30- 60 min in the recovery
Method of measurement
EKG
5
Description
Nausea, vomiting
Timepoint
IN the recoverey room until 1 hour and in ward until 12 hours
Method of measurement
Visual and Asking the patient and her or his parents
6
Description
Thr first time if needed analgesic
Timepoint
In the recovery and ward
Method of measurement
VAS
7
Description
Starting time of fluids
Timepoint
In the ward
Method of measurement
Visual and Asking the patient and her or his parents
Intervention groups
1
Description
Ketamine infiltration in volume 2 cc - 0.5mg / kg, 1 cc into the area the submucousal of anterior fossa and beds of each tonsils after intubation, and three minutes before surgery starting.
Category
Prevention
2
Description
Tramadol infiltration in volume 2 cc - 2mg / kg, 1 cc into the area the submucousal of anterior fossa and beds of each tonsils after intubation, and three minutes before surgery starting.
Category
Prevention
3
Description
Normal saline infilttration in volume 2 cc - 1 cc into the area the submucousal of anterior fossa and beds of each tonsils after intubation, and three minutes before surgery starting.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr Vida Ayatollahi, Anesthesiologist, Assistant professor
Street address
Ebnesina str. Shahid ghandi ave. Shahid Sadoughi Hospital
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, .... University of shahid sadoughi medical university
Full name of responsible person
Dr Hassan Mozaffari
Street address
Yazd University of Medical Sciences, Bahonar Square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, .... University of shahid sadoughi medical university
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
Yazd University of Medical Sciences
Full name of responsible person
Dr Vida Ayatollahi
Position
Anesthesiologist, Member of anesthesia group, Assistant professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4001
Fax
Email
ayatt.vida@ssu.ac.ir; ayati.vida@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Vida Ayatollahi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Bahonar squ.
City
Yazd
Postal code
Phone
+98 35 1822 4001
Fax
Email
ayatt.vida@ssu.ac.ir; ayati.vida@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Vida Ayatollahi
Position
Anesthesiologist, Assistant professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)