Preemptive peritonsillar infiltration with bupivacaine in combination with tramadol improves pediatric posttonsillectomy pain better than using bupivacaine or tramadol alone: A randomized, placebo-controlled, double blind clinical trial
Post tonsillectomy pain is one of most common problem after anesthesia, therefore use of a good anesthesia technique with minimum side effect is a important aim. This study was performed to compare the efficacy of peritonsillar infiltration of bupivacaine, tramadol and combination of bupivacaine-tramadol in post tonsillectomy pain.
Methods: in a double blind trial، 120 ASA I & II childeren condidated for tonsillectomy were randomized into 4 groups: Peritonsillar infiltration with bupivacaine 1mg/kg in Group 1, tramadol 2mg/kg in Group 2, combination of bupivacaine- tramadol in Group 3 and saline in Group 4 was done and post surgical pain were recorded subjective in each person.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308035362N8
Registration date:2013-08-18, 1392/05/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-18, 1392/05/27
Registrant information
Name
Mohammadreza Safavi
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1273 2659
Email address
safavi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preemptive peritonsillar infiltration with bupivacaine in combination with tramadol improves pediatric posttonsillectomy pain better than using bupivacaine or tramadol alone: A randomized, placebo-controlled, double blind clinical trial
Public title
Efficacy of local anaesthesia of bupivacaine in combination with tramadol in post adenotonsillectomy pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 5 to 15 years old who were candidate for tonsillectomy with or without adenoidectomy;
exclusion criteria: patients with acute pharyngeal infection; allergy to bupivacaine or tramadol; acute and active infection of respiratory tract with fever and rhonchi; constant use of sedative or analgesic hypnotic; peritonsillar abscess; renal disease; liver disease; asthma and coagulation disorders.
Age
From 5 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan
City
Isfahan
Postal code
8174675731
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
388526
Health conditions studied
1
Description of health condition studied
Local anaesthetics
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
2
Description of health condition studied
Acute pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Pain
Timepoint
Time of 0,15,30,60 minutes in recovery and 4,8,16,28 hour in ward
Method of measurement
ops (objective pain scale)
Secondary outcomes
1
Description
Consciousness level
Timepoint
Time of 0,15,30,60 minutes in recovery and 4,8,16,24 hours in ward
Method of measurement
Watching in 4 grading
2
Description
Mean blood pressure - mean heart rate
Timepoint
Time of 0,10,30,60 minutes in operation and 0,30,60 minutes in recovery
Method of measurement
Monitoring
3
Description
Nausea and vomiting
Timepoint
After operation to 24 hours
Method of measurement
Watching
4
Description
Mean time to awaking
Timepoint
after operation
Method of measurement
Watching
5
Description
Mean first time to asking analgesic
Timepoint
After operation to 24 hours
Method of measurement
Watching
6
Description
Mean time to extubation
Timepoint
after operation
Method of measurement
Watching
Intervention groups
1
Description
Received peritonsillar injection of bupivacaine 0.5% (1mg/kg) in adrenalin 1:200000 in a volume of 3 cc with normal saline (N/S) before surgical insicion
Category
Prevention
2
Description
Received peritonsillar infiltration of tramadol 2mg/kg in adrenalin 1:200000 in a volume of 3 cc with normal saline (N/S) before surgical insicion
Category
Prevention
3
Description
Received peritonsillar infiltration of tramadol 2 mg/kg and bupivacaine 1mg/kg in adrenalin 1:200000 in a volume of 3 cc before surgical insicion
Category
Prevention
4
Description
Received peritonsillar infiltration of N/S in a volume of 3 cc before surgical insicion
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Dr. Mohammadreza Safavi
Street address
Kashani street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Azim Honarmand
Street address
Kashani street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Safavi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
8174675731
Phone
+98 31 1625 5555
Fax
+98 31 1273 2659
Email
safavi@med.mui.ac.ir
Web page address
www.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Azim Honarmand
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
8174675731
Phone
+98 31 1273 2659
Fax
+98 31 1236 1594
Email
honarmand@med.mui.ac.ir
Web page address
www.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Mohammadreza Safavi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
8174675731
Phone
+98 31 1273 2659
Fax
+98 31 1273 2659
Email
safavi@med.mui.ac.ir
Web page address
www.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)