Determining the Effect of Topical Use of Bupivacaine and Dexamethasone in Tonsilar Cavity to Reduce Post-Tonsillectomy Pain
Design
This study is a randomized clinical trial is a double-blind, for patients undergoing tonsillectomy, in Amir Kabir Hospital .
In this study, 60 patients undergoing tonsillectomy using block randomization (Permuted block randomization ) devided 2 Groups equal use of gases soaked in combination with dexamethasone and bupivacaine or using gses soaked in saline in the tonsillar cavity,
Settings and conduct
In intervention group a 1 mg / kg of solution of bupivacaine 0.5 percent plus 1 mg of dexamethasone per kilogram (maximum 8 mg dexamethasone) and use normal saline to bring it to 10 cc and transfer to 2 gases and immediately after the tonsillectomy put it in the tonsillar cavity for ten minutes .
Blindness due to its double blindness is that in this study only an otolaryngologist responsible for the study is aware of the type of study and the studied groups.
Participants/Inclusion and exclusion criteria
log in :
Patients with frequent pharyngitis
Patients with complaints of bad breath and chronic sore throat
Patients with chronic tonsillitis
Non arrival:
Suspect malignancy
َAsymmetric of tonsiles
Coagulation disorders in patients
Intervention groups
Intervention group: 30 patients immediately after tonsillectomy place a gas soaked with bupivacaine and dexamethasone into the tonsillar cavity of each side for 10 minutes.
Control group: 30 patients immediately after tonsillectomy, place a gas soaked with 10 cc normal saline in the tonsilar cavity of each side.
Main outcome variables
Patients' pain score is measured by checklist in three replicates at 12 hours, 24 hours and one week after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181226042142N1
Registration date:2019-03-16, 1397/12/25
Registration timing:prospective
Last update:2019-03-16, 1397/12/25
Update count:0
Registration date
2019-03-16, 1397/12/25
Registrant information
Name
Mohammadreza Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4633 5314
Email address
www.mm80091@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-23, 1398/03/02
Expected recruitment end date
2019-10-30, 1398/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical use of bupivacaine and dexamethasone in tonsilar cavity in order to reduce pain after tonsillectomy
Public title
The effect of topical use of bupivacaine and dexamethasone in tonsilar cavity in order to reduce pain after tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with frequent pharyngitis
Patients with complaints of chronic bad breath and sore throat
Patients with chronic tonsillitis
Exclusion criteria:
Coagulation disorders in patients
Suspect malignancy
Asymmetric of tonsiles
Age
From 2 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a randomized, double-blind clinical trial for patients undergoing tonsillectomy in Amirkabir Hospital.
A total of 60 patients candidates for Tonsillectomy were randomly divided into two equal groups that using gases soaked dexamethasone and bupivacaine , or normal-saline in order to insert in the tonsilar cavity .
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, only an otolaryngologist who is responsible for the study is aware of the type of study and the studied groups, while the patients , are not aware.also intern responsible for the plan that is responsible for filling the questionnaire ; it is not aware of the type of groups in terms of impacted drugs, and only knows the groups based on A and B, and fills the questionnaire on the basis of it.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Sardasht - Basij Square- Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-02-24, 1397/12/05
Ethics committee reference number
IR.ARAKMU.REC.1397.270
Health conditions studied
1
Description of health condition studied
The Effect of Topical Use of Bupivacaine and Dexamethasone in Tonsilar Cavity in order to Reduce Pain After Tonsillectomy
ICD-10 code
J35
ICD-10 code description
Chronic diseases of tonsils and adenoids
Primary outcomes
1
Description
Intensity of pain
Timepoint
12 hours later and 24 hours later and one week after the intervention
Method of measurement
Based on checklist
2
Description
Number of nausea and vomiting
Timepoint
12 hours later and 24 hours later and one week after the intervention
Method of measurement
Based on checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After obtaining informed consent, 30 patients immediately after tonsillectomy place a gas soaked with bupivacaine and dexamethasone into the tonsillar cavity of each side for 10 minutes. In patients, they are given a 1 mg / kg of solution of bupivacaine 0.5 percent plus 1 mg of dexamethasone per kilogram (maximum 8 mg dexamethasone) and use normal saline to bring it to 10 cc and transfer to 2 gases and immediately after the tonsillectomy put it in the tonsillar cavity for ten minutes .Then, the pain score of patients in each of the two groups was measured in three replicates at 12 hours, 24 hours and one week after the intervention based on the checklist prepared.
Category
Treatment - Drugs
2
Description
Control group: After obtaining informed consent, 30 patients immediately after tonsillectomy, place a gas soaked with 10 cc normal saline in the tonsilar cavity of each side. Then, the pain levels of the patients in the two groups,measured in three replicates, 12 hours later ,24 hours later and one week after the intervention based on the checklist.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kabir Hospital in Arak
Full name of responsible person
Mohammad Reza Mohammadi
Street address
Shahid Shiroodi Street - Nursing Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3313 4715
Email
Rsearch@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjmandzadegan
Street address
sardasht - The Effect of Topical Use of Bupivacaine and Dexamethasone in Tonsilar Cavity in order to Reduce Pain After Tonsillectomy
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
Rsearch@arakmu.ac.ir
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 Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammadreza Mohammadi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 29, Shahid Hamid Reza Shamsi Avenue,Imam Khomeini Street
City
Khomein
Province
Markazi
Postal code
3881963356
Phone
+98 86 4633 5314
Fax
Email
www.mm80091@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammadreza Mohammadi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 29, Shahid Hamid Reza Shamsi Avenue,Imam Khomeini Street
City
Khomein
Province
Markazi
Postal code
3881963356
Phone
+98 86 4633 5314
Fax
Email
www.mm80091@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Reza Mohammadi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Ear, Nose, and Throat
Street address
shahid hamidreza shamsi alley - Emam khomeini street
City
khomein
Province
Markazi
Postal code
3881963356
Phone
+98 86 4633 5314
Email
www.mm80091@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available