Postoperation pain in children has been remained as a problem. We conducted a double blind Randomized Clinical Trial to study the effect of Tramadol on postoperation pain control in children undergoing Tonsillectomy and Adenotonsillectomy. The study population consisted of 72 children aged 4-10 years that they were candidates for Tonsillectomy and Adenotonsillectomy in Rasul Akram hospital. The children were allocated to 2 groups using block randomization. one group received Tramadol and the other group received a placebo. Anesthetic technique was general and was similar in all cases. After Tonsillectomy: Injection Tramadol(2 mg/kg) was diluted with Saline to 10 cc and was put on both tonsillar fossa for 5 minutes. In control group, Swab soaked in10 cc of normal saline and was given on both tosillar fossa. Patient and anesthesiologist were not aware of the nature of the drug and only operating room technician was aware of the prescribing drug(the study was double blind). The pain was assessed with wong Baker visual scale and were scored from 1 to 6(1.No pain, 6.Sever pain ). The patient was assessed at 0(Recovery), 2, 4, 6, 12, 18 and 24 hours after operation and 7 days after that.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013082014199N3
Registration date:2013-11-03, 1392/08/12
Registration timing:na
Last update:
Update count:0
Registration date
2013-11-03, 1392/08/12
Registrant information
Name
Leila Mounesan
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 9763
Email address
l-mounesan@farabi.tums.ac.ir
Recruitment status
Not enough for processing
Funding source
Research Council of Iran University of Medical Sciences
Expected recruitment start date
2012-07-05, 1391/04/15
Expected recruitment end date
2003-07-21, 1382/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Tramadol and Placebo on postoperation pain control in children undergoing Tonsillectomy and Adenotonsillectomy
Public title
The effect of Tramadol on postoperation pain control in children undergoing Tonsillectomy and Adenotonsillectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Children aged 4-10 years old, who were in ASA physical status classification and have been placed in groups I and II, and they were candidates for tonsillectomy with or without adenoidectomy. Exclusion criteria: Sensitivity to opioids or local anesthetics, contraindication opioids or local anesthetics, Asthma, kidney disease, liver disease, throat infections, coagulation disorders
Age
From 4 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Iran University of Medical Sciences, Department of Ethics
Street address
Iran University of Medical Sciences Central Campus, Shahid Hemmat Highway, Adjacent to Milad Tower, Tehran, Iran
City
Tehran
Postal code
Approval date
2012-07-01, 1391/04/11
Ethics committee reference number
573/ 130/ د/ 91
Health conditions studied
1
Description of health condition studied
Acute pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Acute pain
Timepoint
At 0(Recovery), 2, 4, 6, 12, 18 and 24 hours after the operation and 7 days after that
Method of measurement
wong Baker visual scale
Secondary outcomes
1
Description
Nausea and Vomiting
Timepoint
At 0(Recovery), 2, 4, 6, 12, 18 and 24 hours after the operation and 7 days after that
Method of measurement
Observation
2
Description
Bleeding
Timepoint
At 0(Recovery), 2, 4, 6, 12, 18 and 24 hours after the operation and 7 days after that
Method of measurement
Observation
Intervention groups
1
Description
Injection Tramadol 2 mg/kg(Manufacturer: Tehran Shimi) was diluted with Saline to 10 cc and was put on both tonsillar fossa for 5 minutes
Category
Prevention
2
Description
Swab soaked in10 cc of normal saline and was given on both tosillar fossa
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital, Ear-Nose-Throat [ENT] operating room, Department of ear-Nose-Throat [ENT]
Full name of responsible person
Dr.Mahmoudreza Alebuye
Street address
Department of ear-Nose-Throat [ENT], Rasool Akram Hospital, Niyaesh Ave., Sattar Khan St., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Iran University of Medical Sciences
Full name of responsible person
Dr.Seyed Abbas Motevalian
Street address
Iran University of Medical Sciences Central Campus, Shahid Hemmat Highway, Adjacent to Milad Tower, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Iran 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
Rasoul Akram Hospital, Ear-Nose-Throat [ENT] operating room, Department of ear-Nose-Throat [ENT]
Full name of responsible person
Dr.Mahmoudreza Alebuye
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of ear-Nose-Throat [ENT], Rasool Akram Hospital, Niyaesh Ave., Sattar Khan St., Tehran
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2458
Fax
Email
m-alebouyeh@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasoul Akram Hospital, Ear-Nose-Throat [ENT] operating room, Department of ear-Nose-Throat [ENT]
Full name of responsible person
Dr.Mahmoudreza Alebuye
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of ear-Nose-Throat [ENT], Rasool Akram Hospital, Niyaesh Ave., Sattar Khan St., Tehran
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2458
Fax
Email
m-alebouyeh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leila Mounesan
Position
Masters
Other areas of specialty/work
Street address
Center for Academic and Health Policy, No.12, Nosrat St., 16th Azar St., Tehran
City
Tehran
Postal code
Phone
+98 21 6641 9763
Fax
+98 21 6641 9763
Email
lmmounesan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)