the effect of topical administration on pain after tonsillectomy.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 96 children aged 5-12 years. For randomization using of random numbers table, hiding method: opaque sealed envelopes
Settings and conduct
The study will be done, in Imam Khomeini Hospital in the Ahvaz. Patients who will enter in the study, without awareness of which group they are attending, they will be operated. After anesthesia and 10 minutes before surgery, bupivacaine or placebo will be direct-injected to peritonsillar. When the operate will be ended, patients will be observed at 24 hours. During the hospitalization, the pain will be recorded three times.
Participants/Inclusion and exclusion criteria
The inclusion criteria: Tonsillectomy candidate; age between 5-12 years Exclusion criteria : coagulation disorder; acute pharyngitis; active respiratory tract infection
Intervention groups
Intervention group1: there are 48of attended patients (according to the inclusion criteria o), who they will receive Bupivacaine 3 milliliter (ّFrance Astra Zeneca company) as a direct peritonsillar injection, before Surgery. 10 minutes later surgery will be started.
Control group: there are 48of attended patients (according to the inclusion criteria ) who they will not receive any Bupivacaine before surgery (according to the references, if patients did not get the drug, they will not harm and this is acceptable).
Main outcome variables
The severity of the pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180909040979N6
Registration date:2020-05-14, 1399/02/25
Registration timing:registered_while_recruiting
Last update:2020-05-14, 1399/02/25
Update count:0
Registration date
2020-05-14, 1399/02/25
Registrant information
Name
MARYAM ZAMANKHANI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 4760
Email address
zamankhani.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-24, 1398/08/02
Expected recruitment end date
2020-05-24, 1399/03/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of bupivacaine on pain after tonsillectomy
Public title
Examination of bupivacaine for pain after tonsillectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
tonsillectomy candidate
age between 5-12 years
Exclusion criteria:
coagulation disorder ;
Symptoms of acute pharyngitis;
Active upper respiratory tract infection
Age
From 5 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization Randomization unit: individual Randomization tool: with using a random numbers table How to create a random sequence: using a random numbers table to read it from top to bottom and the even numbers belong to intervention group and the odd numbers belong to control group. Allocation concealment:using of Sequentially numbered, sealed, opaque envelopes, In this way that the numbers obtained by the random numbers table will be written on the cards respectively. each card will be put inside sealed opaque envelopes.Then envelopes will be numbered and placed in boxes respectively. In the next stage, the patients will enter the group by taking the envelopes respectively (Preparation of the envelopes will be done by the secretary and the physician will not be informed of them)
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, health care workers in charge of patient care, data collection officials, and those who evaluate the outcome are blind to how they work.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences., Research Deputy.,Blvd. Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Approval date
2014-07-26, 1393/05/04
Ethics committee reference number
ajums.REC.1393.146
Health conditions studied
1
Description of health condition studied
Tonsilectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain intensity after tonsillectomy
Timepoint
6,12,24 hours after surgery
Method of measurement
Visual Analog Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group includes 48 patients who entered the study (according to theinclusion criteria ) who injected 3 ml of bupivacaine (the French pharmaceutical company Astrazenka) directly into the space before the operation. They will receive around the tonsils (in the upper and lower bridge of the tonsils) and surgery will begin after 10 minutes.
Category
Prevention
2
Description
Control group: This group includes 48 patients who entered the study (according to the inclusion criteria ) who will not receive bupivacaine (according to the references, if the drug is not given, the patient will not be harmed, and this is confirmed).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomini Hospital
Full name of responsible person
Fatemeh Javaherforoosh zadeh
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3221 6501
Email
prc@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi, PhD
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 3738
Email
mbadavi@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Javaherforoosh zadeh
Position
Anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
آدرس خیابان Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3221 6501
Email
f_javaherforoosh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Javaherforoosh zadeh
Position
Anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
آدرس خیابان Imam Khomeini Hospital, Azadegan Ave. خیابان آزادگان، بیمارستان امام خمینی (ره) شهر Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3221 6501
Email
f_javaherforoosh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Javaherforoosh zadeh
Position
Anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3221 6501
Email
f_javaherforoosh@yahoo.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