The objective of this randomized clinical trial is to investigate the effect of analgesic efficacy of 0/5mg/kg oral dextromethorphan on postoperative pain in adenotonsillectomy compared with placebo. In this study, 160 children 3-12 years old undergoing surgery for adenotonsillectomy who meet the inclusion/exclusion criteria will be recruited and randomly assigned into intervention or control to four (A,B,C,D) equal groups (40 patients). Two hours before anesthesia, groups A&B will receive 0/5mg/kg oral syrup of dextrometorphan and groups C&D will receive placebo. After operation, groups A&C will receive 0/5mg/kg oral syrup dextrometorphan and groups B&D will receive placebo (in 24 hour). The pain intensity will be evaluated every 6 hours (during the first 24 hour postoperative) by Oucher test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104226252N1
Registration date:2011-06-30, 1390/04/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-30, 1390/04/09
Registrant information
Name
Soroush Amani
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1226 4834
Email address
samani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellery for Research, Shahrekord University of Medical Sciences.
Expected recruitment start date
2011-06-14, 1390/03/24
Expected recruitment end date
2012-01-20, 1390/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of Dextromethorphan with Placebo on postoperative pain in adenotonsillectomy
Public title
The comparison of the effect of Dextromethorphan with Placebo on postoperative pain in adenotonsillectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: children with 3-12 years old, undergoing surgery for adenotonsilectomy, not having background on bloodshed disease, non addicted parents, not using walnuts and nuts in 10 recent days, not being prohibited from public operation, not having allergy to drugs
Exclusion criteria: severe bloodshed during operation, operation takes time more than 30 min, Laryngospasm during extubation, need to a second operation, bloodshed of the operation area after operation, post operation breathing problem
Age
From 3 years old to 12 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
160
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
Vice chansellor for research, Shahrekord University of Medical Sciences
Street address
Vice chancellor for research, Central Building of Shahrekord University of Medical Sciences, Kashani Avenue
City
Shahrekord
Postal code
Approval date
2005-04-21, 1384/02/01
Ethics committee reference number
84-2-5
Health conditions studied
1
Description of health condition studied
Intensity of Pain
ICD-10 code
R46
ICD-10 code description
Symptoms and signs involving appearance and behaviour
Primary outcomes
1
Description
pain intensity
Timepoint
before and after interval
Method of measurement
visual scale af pain
Secondary outcomes
empty
Intervention groups
1
Description
5ml of decstrometorphan 2 h before and after operation every 6 h till 24h
Category
Treatment - Drugs
2
Description
Placebo 2h before and after operation every 6h till 24h
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Dr Hossein Madineh
Street address
Anaesthesiology department, Hajar hospital, Parastar St.
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences, Vice chancellory for research
Full name of responsible person
Mahmoud Mobasheri
Street address
Shahrekord University of Medical Science, Kashani St.
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University of Medical Sciences, Vice chancellory for research
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
Shahrekord University of Medical Sciense
Full name of responsible person
Hossein Madineh
Position
Assistant professor ,Anesthesiology department
Other areas of specialty/work
Street address
Anesthesiology department, Hajar hospital, Parastar ST.
City
Shahrekord
Postal code
Phone
+98 38 1222 0016
Fax
Email
hosseinmadineh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Hossein Madineh
Position
Assistant professor, Anaesthesiology departmet
Other areas of specialty/work
Street address
Anaesthesiology department, Hajar hospital, Parastar St.
City
Shahrekord
Postal code
Phone
+98 38 1222 0016
Fax
Email
hosseinmadineh@gmail.com
Web page address
WWW.skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Science
Full name of responsible person
Soroush Amani
Position
Assistant professor, ENT department
Other areas of specialty/work
Street address
ENT dept, Kashani hospital, Parastar St.
City
Shahrekord
Postal code
Phone
Fax
Email
soamani2008@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)