Objectives: To determine the effect of topical bupivacaine on postoperative pain after tonsillectomy 6 hours / determine the effectiveness of topical bupivacaine on postoperative pain after tonsillectomy 24 hours / when the application first dose analgesic effect of the local anesthetic bupivacaine after tonsillectomy.
Designed: to check the amount of pain FPRS (Face Pain Rating Scale) is used preoperatively to parents and children will be taught. 6 and 24 hours after surgery are the result of the questionnaire is written sanctity. Term during oral fluids to start the first innings against periods request is recorded. Continues until the completion of the study sample.
Method: How to do: After obtaining informed consent from parents of all patients who have undergone tonsillectomy be randomly divided into control and experimental groups. Following surgery for all patients with the same approach, we transferred them to the department for each case is specific.
Participants: All patients who have undergone tonsillectomy is supposed to be. Inclusion criteria: 1 - children who have undergone tonsillectomy should be 0.2 - parental consent. Exclusion criteria: 1 - history of any drug allergy. 2 - Lack of parental consent.
Interventions: for the treatment group (0.5 mg per kg), local injection of bupivacaine is injected into the tonsillar bed. And for the control group of placebo (sterile water) is injected.
The main outcome variables: time to apply the first dose of analgesic / pain 6 hours after surgery / pain 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041617296N2
Registration date:2014-05-05, 1393/02/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-05, 1393/02/15
Registrant information
Name
Neda Jasemi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 331 2257
Email address
saki_n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2013-05-06, 1392/02/16
Expected recruitment end date
2013-11-01, 1392/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical bupivacaine on pain relieve after tonsillectomy in children referred to Ahvaz Imam Khomeini Hospital in 2013-2014
Public title
Effect of topical bupivacaine on pain relieve after tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children who have undergone tonsillectomy; parental consent to participate in the study. Exclusion criteria: history of any drug allergy; no parental consent.
Age
From 4 years old to 13 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan blv- Ahvaz
City
Ahvaz
Postal code
Approval date
2013-05-22, 1392/03/01
Ethics committee reference number
ajums.rec.1392.253
Health conditions studied
1
Description of health condition studied
Tonsilit
ICD-10 code
C09.9
ICD-10 code description
Tonsil, unspecified
Primary outcomes
1
Description
Reduce pain
Timepoint
After surgery
Method of measurement
FPRS(Face Pain Rating Scale)
Secondary outcomes
1
Description
Change pain
Timepoint
After surgery
Method of measurement
FPRS(Face Pain Rating Scale)
Intervention groups
1
Description
Local bupivacaine before surgery intervention group
Category
Treatment - Drugs
2
Description
for the placebo control group (distilled water) was used
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital ,ahvaz jundishapur university medical of sceinces
Full name of responsible person
Street address
ENT unit,Imam Khomeini Hospital ,ahvaz jundishapur university medical of sceinces,ahvaz,iran
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice – Chancellery of Research & Technology Affairs-ahvaz jundishapur university of medical scienc
Full name of responsible person
Dr. Nader Saki
Street address
ENT Department, Imam hospital, ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice – Chancellery of Research & Technology Affairs-ahvaz jundishapur university of medical scienc
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Neda jasemi
Position
ENT resident
Other areas of specialty/work
Street address
ENT Department, Imam hospital, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1222 7410
Fax
Email
Dr_BAHAR2001@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Neda jasemi
Position
ENT resident
Other areas of specialty/work
Street address
ENT Department, Imam hospital, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1222 7410
Fax
Email
Ahvaz.ent@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Neda jasemi
Position
ENT residenct
Other areas of specialty/work
Street address
ENT Department, Imam hospital, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1222 7410
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)