The purpose of this double blind RCT with placebo was to assess the effect of laser therapy for post tonsillectomy pain. A total of sixty patients were included in two groups. Immediately after tonsillectomy in the first group; both tonsilar beds was irradiated by 980 nm infrared laser, 100Hz, 4 Joules for each tonsil, but in the second group; they received 0 Joule with switch off laser. Operation was performed by a single surgeon and anesthetist blinded for the study intervention. Type of anesthesia is the same in two groups. In the recovery, we recorded pain intensity by VAS (from 0 to 10) and odynophgia by 4 scores from [0 (NO pain) till to 4 (Severe pain)] and amount of analgesics used in both groups. Then, during 2 – 4 – 6 – 8 – 12 - 24 hours post-operative periods (at Ward), all above mentioned variables were measured again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107181772N7
Registration date:2011-12-10, 1390/09/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-10, 1390/09/19
Registrant information
Name
Dawood Aghamohammadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1381 8940
Email address
aghamohammadid@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research, Tabriz University of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-08-23, 1390/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of low level laser irradiation at the end of surgery for pain reduction in adult tonsillectomy
Public title
Effect of laser therapy for post tonsillectomy pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA 1-2, age 14-40
Exclusion criteria: Drug addiction, Bleeding, Psychological disorder, traumatization, operation time more than 1 hour
Age
From 14 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancseller of research, Tabriz Unoversity of Medical Sciences
Street address
Daneshghah street - Fuculty of medicine -Anesthsiology resaech team
City
Tabriz
Postal code
Approval date
2011-04-05, 1390/01/16
Ethics committee reference number
5/4/259
Health conditions studied
1
Description of health condition studied
Tonsillectomy
ICD-10 code
J35-J36
ICD-10 code description
Chronic diseases of tonsils and adenoids
Primary outcomes
1
Description
pain
Timepoint
0 - 2 -4 - 6 - 8 - 12 -24 hours in post operative periods
Method of measurement
visual Analouque scale
2
Description
Odynophagia
Timepoint
0 - 2 -4 - 6 - 8 - 12 -24 hours in post operative periods
Method of measurement
visual Analouque Scale
Secondary outcomes
1
Description
analgesic consumpation
Timepoint
0-2 -4 -6 - 8- 12 -24 hours in post operative periods
Method of measurement
milligram
Intervention groups
1
Description
Low level Laser Therapy on bed of tonsills
Category
Treatment - Other
2
Description
Low Level laser Therapy with switch off laser(Placebo)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Teaching Hospital
Full name of responsible person
Dawood Aghamohammadi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Science - Fuculty of medicine -Anesthsiology resaech team
Full name of responsible person
Dawood Aghamohammadi
Street address
Daneshghah street-Fuculty of medicine -Anesthsiology resaech team
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 Science - Fuculty of medicine -Anesthsiology resaech team
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 science
Full name of responsible person
Dawood Aghamohammadi
Position
Assitant Professor
Other areas of specialty/work
Street address
Daneshghah street -Fuculty of medicine -Anesthsiology resaech team