Objectives:
Comparison of local injection of Bupivacaine and Normal Saline on post operative pain in children who underwent tonsillectomy
Design:
This double-blind prospective, randomized study will be done among patients with tonsillectomy
Setting and conduct:
96 patients scheduled for general anesthesia will be received midazolam 1 mg intravenously 5 min before entering the operating room. Premedication will perform with fentanyl 2 micro-gram/kg. General anesthesia will perform with 4 mg/kg sodium thiopental
Inclusion criteria:
The parent's parents consent; Age between 5 and 12 years old; ASA class I
Exclusion criteria:
History of allergy to Bupivacaine; previous complications with general anesthesia; Heart disease; Difficult Intubation
Intervention:
Groups "one" and "two" will be received 12.5 mg local injection of Bupivacaine or 3 ml of Normal Saline at the beginning of the surgery, respectively.
Variables:
Postoperative pain and needs for analgesics will measure at 1, 2, 4, 8, 12, 18 and 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014080918744N1
Registration date:2015-05-10, 1394/02/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-10, 1394/02/20
Registrant information
Name
Fahime Atigh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 0168
Email address
atigh.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-06-05, 1394/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of local injection of Bupivacaine and Normal Saline on post operative pain in children who underwent tonsillectomy
Public title
Comparison of local injection of Bupivacaine and Normal Saline on post operative pain in children who underwent tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The parent's parents consent; Age between 5 and 12 years old; ASA class I
Exclusion criteria:
History of allergy to Bupivacaine; previous complications with general anesthesia; Heart disease; Difficult Intubation
Age
From 5 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
No. 21, Ave. 1, Golestan Blvd.
City
Ahvaz
Postal code
6135733777
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
Pain
ICD-10 code
R52.0
ICD-10 code description
Acute Pain
Primary outcomes
1
Description
Pain
Timepoint
1,2,4,8,12, 18 and 24 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Opioid Consumption
Timepoint
24 hours after surgery
Method of measurement
Milligram
Intervention groups
1
Description
Bupivacaine:
Dose: 12.5 mg
Number of using: Once
Factory name: Astra Zeneca
Manufacturing Country's Name: France
Location prescribed: Local injection
Administration time: At the beginning of the surgery
Category
Treatment - Drugs
2
Description
Normal Saline:
Dose: 3 ml
Number of using: Once
Factory name: Loghman
Manufacturing Country's Name: Iran
Location prescribed: Local injection
Administration time: At the beginning of the surgery