Objective: To investigate the post-operative pain in 200 children after tonsillectomy and to compare the analgesic effect between two drugs: Acetaminophen and Celecoxib.
Study design: A randomized double-blind study.
Inclusion criteria: 3 - 15 years old children; no growth anomalies; physical or psychological problems; living nearby the hospital; at least one of the parents should have high school education.
Exclusion criteria: history of allergy to celecoxib or other NSAIDs; asthma; kidney or liver dysfunction or a hemorrhagic diathesis and sulphonamide allergy; social reasons.
Interventions: the first dose of acetaminophen after discharge is consisted of oral suspension 120mg/5 ml, 400 mg at 4 hours after tonsillectomy and then every 6 hours for seven days. The first dose of celecoxib after discharge is consisted of oral suspension 100mg/5 ml, (50mg for children under 25 kg and100mg for upper) at 4 hours after tonsillectomy and then every12 hours for seven days. The first and second pain score will be assessed at 4 and 8 hours after operation. The total duration of hospital admission is at least 8 hours. Primary outcome parameter: the intensity of postoperative pain. The questionnaire is going to be used in assessing the post-operative pain, daily activity and also food consumption for 7 days after discharge. To record the intensity of postoperative pain, the simplified version of Visual Analog Scale (VAS)is applied. Parents must express their children’s pain on an -point rating scores (0= no pain, 5 = worst pain. Pain will be checked four times a day in two weeks after Tonsillectomy (before breakfast, lunch and dinner and sleeping).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080919470N29
Registration date:2016-12-27, 1395/10/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-27, 1395/10/07
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2015-04-30, 1394/02/10
Expected recruitment end date
2015-09-30, 1394/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic efficacy of celecoxib and acetaminophen in pediatric Tonsillectomy
Public title
Comparison of analgesic efficacy of celecoxib and acetaminophen in pediatric Tonsillectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 3 - 15 years old children; no growth anomalies; physical or psychological problems; living nearby the hospital; at least one of the parents should have high school education. Exclusion criteria: history of allergy to celecoxib or other NSAIDs; asthma; kidney or liver dysfunction or a hemorrhagic diathesis and sulphonamide allergy; social reasons.
Age
From 3 years old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be performed by referring to the www.randomization.com
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiaz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
Ir.sums.rec.1394.s946
Health conditions studied
1
Description of health condition studied
tonsilectomy
ICD-10 code
J35
ICD-10 code description
Chronic disease of tonsils and adenoid
Primary outcomes
1
Description
Pain score intensity
Timepoint
4 times a day; before breakfast, lunch and dinner and sleeping. Two weeks after Tonsillectomy
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
1
Description
Bleeding
Timepoint
Daily
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group 1: The first dose of acetaminophen after discharge will consist of oral suspension 120mg/5 ml, 400 mg at 4 hours after tonsillectomy and then every 6 hours for seven days.
Category
Treatment - Drugs
2
Description
Intervention group 2: The first dose of celecoxib after discharge will consist of oral suspension 100mg/5 ml, (50mg for children under 25 kg and100mg for upper) at 4 hours after tonsillectomy and then every12 hours for seven days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Bahar Noori Dolat abadi
Street address
Khalili Hospital, Khalili Street
City
Shiraz
2
Recruitment center
Name of recruitment center
Dasghib Hospital
Full name of responsible person
Bahar Noori Dolat Abadi
Street address
Dasghib Hospital, Hafezieh Squre, Golestan BLVD.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice Chancellor for Research ,Shiraz University of Medical Sciences-7th floor-Central Building of Shiraz University of Medical Sciences , Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Bahar Nouri Rahmt Abadi
Position
Physician, Anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
baharnoori64@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Mohammad Hosin Eghbal
Position
Anesthesilogist
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
mheghbal@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in english teaching, BS in anesthesia, English Consultant
Other areas of specialty/work
Street address
5th floor, Mohammad Rasul Allah Research Towe, Khalili Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)