Comparison of dextromethorphan and ibuprofen effect on post adenotonsillectomy pain severity
Design
Phase 2-3 randomized clinical trial with parallel groups which will be conducted on 90 patients undergoing adenotonsillectomy
Settings and conduct
This study will be conducted with the aim of comparing the effect of dextromethorphan and ibuprofen effect on post adenotonsillectomy pain severity in 90 patients candidate for adenotonsillectomy. After inclusion in the study, using block randomization method with blocks on 9, the patients will be assigned into three groups; dextrometorphan group receiving 1 mg/kg of dextrometorphan syrup in 10 cc juice, ibuprofen group receiving 10 mg/kg of ibuprofen syrup in 10 cc juice and placebo group receiving 10 cc juice. These drugs will be given orally 30 minutes before surgery. Finally, 1, 2, 4 and 6 hours after surgery the pain severity will be measured using visual analogue scale and will be compared together.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age of 3-12 years; Being candidate for adenotonsillectomy
Exclusion criteria:Having underlying disease; Having contraindication for using the study drugs
Intervention groups
Intervention group 1: Receiving 1 mg/kg of dextrometorphan syrup in 10 cc juice 30 minutes before the operation
Intervention group 2: Receiving 10 mg/kg of ibuprofen syrup in 10 cc juice 30 minutes before the operation
Control group: Receiving 10 cc juice 30 minutes before the operation
Main outcome variables
Post-adenotonsillectomy pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180831040914N1
Registration date:2018-09-09, 1397/06/18
Registration timing:registered_while_recruiting
Last update:2018-09-09, 1397/06/18
Update count:0
Registration date
2018-09-09, 1397/06/18
Registrant information
Name
Javad Keykha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
j.keykha72@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-06, 1397/06/15
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of dextromethorphan and ibuprofen effect on post adenotonsillectomy pain severity
Public title
Dextromethorphan and ibuprofen effect on post adenotonsillectomy pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 3-12 years
Being candidate for adenotonsillectomy
Exclusion criteria:
Having underlying disease
Having contraindication for using the study drugs
Age
From 3 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with blocks of 9
Considering the sample size of 90, 10 blocks with 9 cards (3 cards for each group) will be selected; by selecting each block, 3 patients will be assigned into each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs and placebo will be coded as A, B and C and will be similar in shape so the patient and the caregiver (patient's physician) will be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Approval date
2017-05-07, 1396/02/17
Ethics committee reference number
IR.ZAUMS.REC.1396. 17
Health conditions studied
1
Description of health condition studied
Adenotonsillectomy
ICD-10 code
J35
ICD-10 code description
Chronic diseases of tonsils and adenoids
Primary outcomes
1
Description
Post-adenotonsillectomy pain severity
Timepoint
1, 2, 4 and 6 hours after the operation
Method of measurement
By using Visual Analog Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Receiving 1 mg/kg of dextrometorphan syrup in 10 cc juice 30 minutes before the operation
Category
Treatment - Drugs
2
Description
Intervention group 2: Receiving 10 mg/kg of ibuprofen syrup in 10 cc juice 30 minutes before the operation
Category
Treatment - Drugs
3
Description
Control group: Receiving 10 cc juice 30 minutes before the operation
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam al Anbiya Hospital
Full name of responsible person
Javad Keykha
Street address
Khatam al Anbiya Hospital, Jame Jam Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
99167889547
Phone
+98 54 3329 5715
Email
ayubabedi48@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5721
Email
Dr.Taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Javad Keykha
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
ayubabedi48@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Javad Keykha
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
ayubabedi48@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Javad Keykha
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
ayubabedi48@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available