Study of adding Ketamin to pre-incisional Bupivacain injection on post-operative pain relief after tonsillectomy, a Randomized, double blind clinical trial
The aim of the study is to investigate the effect of adding ketamine to bupivacaine injection in incision site on the pain following tonsillectomy. In this prospective randomized double blind clinical trial, 63 patients, aged 40-30 years and ASA class I-II, scheduled for elective surgery were enrolled in 3 groups of 21 persons to receive ketamine (0.5mg/kg), bupivacaine 0.5% (2mg/kg), or ketamine (0.5mg/kg) and bupivacaine 0.5% (2mg/kg) in a total volume of 5 cc. After general anesthesia which is performed with the same method in all groups and at the end surgery, medication is injected in the tensile bed by the surgeon who is blind regarding the intervention type. Hemodynamic criteria, including heart rate and blood pressure, and incidence of postoperative pain with VAS (visual analogue scale) are measured at the end of surgery immediately after anesthesia, and 1, 6, and 24 hours after the surgery. Need to analgesics in 24 hours is also recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903181617N3
Registration date:2010-10-02, 1389/07/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-10-02, 1389/07/10
Registrant information
Name
Mansour Choubsaz
Name of organization / entity
Imam Reza Hospital
Country
Iran (Islamic Republic of)
Phone
+98 83 1724 6708
Email address
mchoubsaz@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences and health Services
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of adding Ketamin to pre-incisional Bupivacain injection on post-operative pain relief after tonsillectomy, a Randomized, double blind clinical trial
Public title
Study of adding Ketamin to pre-incisional Bupivacain injection on post-operative pain relief after tonsillectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 30-40 years old, ASA class I-II, patients whom scheduled for elective adenotonsilectomy surgery with general anesthesia.
Exclusion criteria: History of hemodynamic disturbances, hypersensitivity to study drugs, having impaired anatomical at the site of surgery
Age
From 4 years old to 30 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Kermanshah University of Medical Sciences
Street address
Pro-Vice-Chancellor for Research, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2010-09-19, 1389/06/28
Ethics committee reference number
7/420/6313
Health conditions studied
1
Description of health condition studied
Sore throat
ICD-10 code
J06.0
ICD-10 code description
Acute laryngopharyngitis
Primary outcomes
1
Description
heart rate
Timepoint
0-1-6-24 hours
Method of measurement
cardiac monitoring
2
Description
Blood pressure
Timepoint
0, 1, 6, 24 hours after surgery
Method of measurement
sphygmomanometer
Secondary outcomes
1
Description
Sore throat
Timepoint
0, 1, 6, 24 hours after surgery
Method of measurement
visual analogue scale
Intervention groups
1
Description
Ketamin 0.5 mg/kg, up to 5 ml, injection in tonsillar bed
Category
Treatment - Drugs
2
Description
Bupivacaine 0.5% 2mg/kg, up to 5 ml, injection in tonsillar bed
Category
Treatment - Drugs
3
Description
Ketamin 0.5mg/kg + Bupivacaine 0.5% 2mg/kg, up to 5 ml, injection in tonsillar bed
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Dr. Farid Najafi
Street address
Pro-Vice-chancellor for research, Kermanshah University of Medical Sciences
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences and health Services
Full name of responsible person
Dr. Samad Nourizad
Street address
Kermanshah University of Medical Sciences and health Services
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences and health Services
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
Imam Reza Hospital
Full name of responsible person
Sara Joreir Ahmadi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Departement of Anesthesia and intensive care, Imam Reza Hospital
City
Kermanshah
Postal code
6718938179
Phone
+98 83 1724 6708
Fax
+98 83 1724 4969
Email
mchoobsaz@kums.ac.ir
Web page address
mchoobsaz@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Mansour Choubsaz
Position
Anesthesiologist/Assisstant Professor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences and Health Services
City
Kermanshah
Postal code
6718938179
Phone
+98 83 1724 6708
Fax
+98 83 1724 4969
Email
mchoobsaz@kums.ac.ir
Web page address
mchoobsaz@kums.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)