Aim of the study was evaluation of the effect of Bupivacaine on post tonsillectomy pain. This was a double blind randomized clinical study in a single center (Dastgheib University Hospital Shiraz-Iran). Trained anesthesia nurse and statistician as assessors have been blinded. Patients were divided in three groups; Group 1 (100 patients): Bupivacaine injection before incision. Group 2 (100 patients): Bupivacaine injection after excision of tonsils. Group 3 (100 patients): Bupivacaine injection was not used. The groups were also allowed to take oral acetaminophen if needing. Inclusion criteria were: 1) age range 3-15 years old; 2) patients who undergo tonsillectomy due to three or more severe recurrent attacks of tonsillitis within each two consecutive years. Exclusion criteria were: 1) pre operative medical problems such as asthma, diabetes, coagulation disorders, cardiovascular disease, basic metabolic disorder, immune system deficiency and chronic liver or renal disease; 2) Inadequate follow-up and incomplete questionnaires. Primary outcome was pain within 24 hours after operation. Pain had been evaluated by Visual Analog Scale by trained anesthesia nurse in the ward.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014011615496N4
Registration date:2015-09-19, 1394/06/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-19, 1394/06/28
Registrant information
Name
Sareh Roosta
Name of organization / entity
Vice Chancellor for Research and Technology, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5323
Email address
namazi_balini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Shiraz University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Bupivacaine on post tonsillectomy pain
Public title
The effect of local pain killer "Bupivacaine" on post tonsillectomy pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) age range 3-15 years old; 2) patients who undergo tonsillectomy due to three or more severe recurrent attacks of tonsillitis within each two consecutive years.
Exclusion criteria: 1) pre operative medical problems such as asthma, diabetes, coagulation disorders, cardiovascular disease, basic metabolic disorder, immune system deficiency and chronic liver or renal disease; 2) Inadequate follow-up and incomplete questionnaires.
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:
300
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
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2006-02-12, 1384/11/23
Ethics committee reference number
CT-84-2682
Health conditions studied
1
Description of health condition studied
Tonsillectomy
ICD-10 code
J35.1, J35
ICD-10 code description
Hypertrophy of tonsils, Hypertrophy of tonsils with hypertrophy of adenoids
Primary outcomes
1
Description
Post-tonsillectomy pain
Timepoint
within 24 hours after operation
Method of measurement
Pain had been evaluated by Visual Analog Scale by trained anesthesia nurse in the ward.
Secondary outcomes
empty
Intervention groups
1
Description
Group 1-(Intervention Group): 10 ml of Bupivacaine 5 mg/ml in each site of operation-totally 20 ml- was injected before incision. After surgery, this group was also allowed to take oral acetaminophen )children less than 12 years: 10-15 mg/kg/dose, each 6 hours and children 12-15 years: 325-650 mg, each 6 hours) if needed.
Category
Treatment - Drugs
2
Description
Group 2-(Intervention Group): 10 ml of Bupivacaine 5 mg/ml in each site of operation-totally 20 ml- was injected after excision of tonsils. After surgery, this group was also allowed to take oral acetaminophen )children less than 12 years: 10-15 mg/kg/dose, each 6 hours and children 12-15 years: 325-650 mg, each 6 hours) if needed.
Category
Treatment - Drugs
3
Description
Group 3-(Control Group): Bupivacaine injection was not used. After surgery, this group was also allowed to take oral acetaminophen (children less than 12 years: 10-15 mg/kg/dose, each 6 hours and children 12-15 years: 325-650 mg, each 6 hours) if needed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Dastgheib Hospital
Full name of responsible person
Dr. Mohammad Faramarzi
Street address
Hafez Street, Next to National Garden
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand Street
City
Shiraz
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, Shiraz 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
Center for Development of Clinical Studies, Vice Chancellor of Research and Technology, Shiraz Unive
Full name of responsible person
Sareh Roosta
Position
MSc of Biostatistics
Other areas of specialty/work
Street address
Nemazee Square,Center for Development of Clinical Research of Nemazee Hospital
City
Shiraz
Postal code
Phone
+98 71 3612 5323
Fax
Email
Roosta.Sareh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Otolaryngology, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Faramarzi
Position
Associate Professor of Otolaryngology
Other areas of specialty/work
Street address
Department of Otolaryngology, Khalili Hospital, Khalili Street
City
Shiraz
Postal code
Phone
+98 71 3629 1478
Fax
Email
Faramarzi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Center for Development of Clinical Studies of Nemazee Hospital, Vice Chancellor of Research and Tech
Full name of responsible person
Sareh Roosta
Position
MSc of Biostatistics
Other areas of specialty/work
Street address
Center for Development of Clinical Research of Nemazee Hospital, Nemazee Square
City
Shiraz
Postal code
Phone
+98 71 3612 5323
Fax
Email
Roosta.Sareh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)