This study will be conducted with the aim of comparing the effect of acetaminophen and dicophenac suppositories on pain severity in patients undergoing tonsillectomy.
Design
Phase 2-3 randomized clinical trial with parallel groups which will be conducted on 100 patients candidate for tonsillectomy.
Settings and conduct
This study will be conducted with the aim of comparing the effect of acetaminophen and dicophenac suppositories on pain severity in 100 patients candidate for tonsillectomy. After inclusion in the study, using block randomization with quadrilateral blocks method the patients will be assigned into two groups; acetaminophen group receiving 10 mg/kg of acetaminophen suppository and diclophenac group receiving 2 mg/kg of diclophenac suppository. These drugs will be given rectally 5 minutes before surgery. Finally, 1, 6, 12 and 24 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: All children who are candidate for tonsillectomy; age of 5-15 years old
Exclusion criteria: Having syndromic diseases; having underlying diseases
Intervention groups
Intervention group 1: will receive 10 mg/kg Acetaminophen suppository 5 minutes before starting surgery
Intervention group 2: will receive 2 mg/kg Diclophenac suppository 5 minutes before starting surgery
Main outcome variables
Pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171110037345N1
Registration date:2018-02-21, 1396/12/02
Registration timing:registered_while_recruiting
Last update:2018-02-21, 1396/12/02
Update count:0
Registration date
2018-02-21, 1396/12/02
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
ali.safavi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of pre-operative diclophenac and acetaminophen suppositories on postoperative pain severity in children undergoing tonsillectomy
Public title
Comparison the effect of diclophenac and acetaminophen suppositories on pain severity in tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All 5-15 years old children who are candidate for tonsillectomy
Exclusion criteria:
Having syndromic diseases
Having underlying diseases
Age
From 5 years old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization with quadrilateral blocks
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan Medical University of Science
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
2017-06-18, 1396/03/28
Ethics committee reference number
IR.ZAUMS.REC.1396.16
Health conditions studied
1
Description of health condition studied
Hypertrophy of tonsils
ICD-10 code
J35.1
ICD-10 code description
Hypertrophy of tonsils
Primary outcomes
1
Description
Pain severity
Timepoint
1, 6, 12 and 24 hours after surgery
Method of measurement
Using Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 10 mg/kg Acetaminophen suppository 5 minutes before starting surgery
Category
Treatment - Drugs
2
Description
Intervention group 2: 2 mg/kg Diclophenac suppository 5 minutes before starting surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam al Anbiya Hospital
Full name of responsible person
Ali Safavi
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
Ali Safavi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Safavi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
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
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Safavi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
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
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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available