The aim of this study is to compare analgesic efficacy of local injection of clonidine + bupivacaine with intravenous fentanyl for postoperative tonsilectomy. In this double-blind randomized clinical trial, after local ethical committe and Tabriz university research center approval and obtaining informed parental consent, 140 patients (3-12 y) with American society of Anesthesiologists (ASA) status I and II, without upper respiratory tract infection and anemia, undergoing tonsillectomy, were prospectively enrolled from Tabriz Children Hospital during a one-year period of time. The patients were randomized in two 70-patient groups received intravenous fentanyl (1µg/kg) (group F) or infiltration of bupivacaine 0.25% (0.1mg/kg) plus clonidine (1µg/kg) (group BC)after anesthesia induction. The induction and maintenance of anesthesia will be same in both groups. The post-operative pain will be evaluated by Wong-Baker Face Pain Scale (FPS). The homodynamic changes, as well as possible complications will also be determined during first 24 hours hospital stay. The observer and the patients will be blind to the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903064041N1
Registration date:2011-04-14, 1390/01/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-14, 1390/01/25
Registrant information
Name
Mahin Seyedhejazi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 2252
Email address
seidhejazie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2010-04-01, 1389/01/12
Expected recruitment end date
2011-01-01, 1389/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous fentanyl and infiltration of bupivacaine-clonidine in decreasing post tonsillectomy pain and complications in children
Public title
local injection in decreasing post tonsillectomy pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : parent approval; age between 3-12 years old. Exclusion criteria: coexisting diseaes like sever common cold ,anemia.
Age
From 3 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
5136735886
Approval date
1990-01-01, 1368/10/11
Ethics committee reference number
5/4/9503
Health conditions studied
1
Description of health condition studied
pain after adenotonsilectomy
ICD-10 code
J35.3
ICD-10 code description
Hypertrophy of tonsils with hypertrophy of adenoids
Primary outcomes
1
Description
pain
Timepoint
2, 4, 6, 8 hours after operation
Method of measurement
Face Pain Scale
Secondary outcomes
1
Description
analgesic usage
Timepoint
2, 4, 6, 8 hours after operation
Method of measurement
mg/kg
Intervention groups
1
Description
intervention: infiltration of local bupivacaine 0.25% (0.1mg/kg) and clonidine (0.1ml/kg) in the base of tonsils bilaterally
Category
Treatment - Drugs
2
Description
control: intravenous fentanyl (1µg/kg)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
operating room, Tabriz Children Hospital
Full name of responsible person
Dr. Mahin Seyedhejazi
Street address
Tabriz Children Hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Street address
Tabriz Children Hospital
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Tabriz Children Hospital
City
Tabriz
Postal code
5136735886
Phone
+98 41 1526 2250
Fax
+98 41 1526 2279
Email
seidhejazie@yahoo.com , seidhejazie@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Tabriz Children Hospital
City
Ttabriz
Postal code
5136735886
Phone
+98 41 1526 2250
Fax
+98 41 1526 2279
Email
seidhejazie@yahoo.com , seidhejazie@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Tabriz Children Hospital
City
Tabriz
Postal code
5136735886
Phone
+98 41 1526 2250
Fax
+98 41 1526 2279
Email
seidhejazie@yahoo.com , seidhejazie@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)