The purpose of this study is to compare the clinical efficacy of acetaminophen suppository inserted before and after adenotonsillectomy on reducing pain.inclusion criterias are: children 7_15 years undergoing adenotonsillectomy؛children with recurrent tonsillitis؛chronic tonsillitis؛obstructive sleep apnea syndrome and exclusion criterias are: known allergy to acetaminophen؛renal or hepatic dysfunction؛use of pain killers during the past 24 hours؛drug abuse؛diarrhea؛dehydration؛bleeding disorders and.for this purpose, in a clinical trial, 100 patients 7 to 15 years undergoing adenotonsillectomy after the description of the clinical trial and obtaining written consent will randomly be assigned to the study and prepare for the first group acetaminophen suppository 5 minutes before the surgery (after intubation) and the second group will receive the same dose of the suppository before extubation after the end of surgery and the need for pain medication and post-operative pain will be evaluated according to the VAS criteria.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015083023811N1
Registration date:2015-12-07, 1394/09/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-07, 1394/09/16
Registrant information
Name
Atefe Nikjoo
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
nikjoo@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2015-11-06, 1394/08/15
Expected recruitment end date
2016-08-20, 1395/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of acetaminophen suppository before and after adenotonsillectomy on reducing pain in children
Public title
The effect of acetaminophen to reduce pain in tonsillectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: children undergoing adenotonsillectomy؛children 7_15 years with recurrent tonsillitis؛chronic tonsillitis؛obstructive sleep apnea syndrome؛open mouth breathing؛snoring and dysphagia;Exclusion criteria: known allergy to acetaminophen؛renal or hepatic dysfunction؛use of pain killers during the past 24 hours؛drug abuse (due to the high prevalence in the region)؛ known Favism disease؛diarrhea؛dehydration؛bleeding disorders and act surgery lasted more than 30 minutes.
Age
From 7 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
School of Medicine ،College of Medical Sciences and Health Services، Jannat boulevard، Dr Hesabi square، Zahedan
City
Zahedan
Postal code
Approval date
2015-06-28, 1394/04/07
Ethics committee reference number
ir.zaums.rec.1394.147
Health conditions studied
1
Description of health condition studied
Hypertrophy of tonsils and adenoids
ICD-10 code
J35.3
ICD-10 code description
Hypertrophy of tonsils with hypertrophy of adenoids
Primary outcomes
1
Description
pain
Timepoint
2 hours, 6 hours, 12 hours and 24 hours after intervention
Method of measurement
visual annalog pain scale
Secondary outcomes
1
Description
The need for pain medication after surgery
Timepoint
Every 1 hour after intervention
Method of measurement
Frequency of consumption
Intervention groups
1
Description
The first group، rectal acetaminophen 40 mg / kg, five minutes before the surgery (after intubation)
Category
Treatment - Drugs
2
Description
The second group،rectal acetaminophen 40mg / kg after the end of surgery and before extubation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam hospital
Full name of responsible person
Atefe Nikjoo
Street address
Khatam Hospital، Jamejam boulevard، Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology
Full name of responsible person
Dr Hooshang Rafighdoost
Street address
Deputy of Research and Technology ،School of Medicine ،College of Medical Sciences and Health Services، Jannat boulevard، Dr Hesabi square، Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology
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
Zahedan University of Medical Sciences
Full name of responsible person
Dr Gholamali Dashti
Position
Assistant Professor
Other areas of specialty/work
Street address
Khatam Hospital، Jamejam boulevard، Zahedan
City
Zahedan
Postal code
Phone
+98 54 3322 3001
Fax
Email
Drdashti50@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Gholamali Dashti
Position
Assistant Professor
Other areas of specialty/work
Street address
Khatam Hospital، Jamejam boulevard، Zahedan
City
Zahedan
Postal code
Phone
+98 54 3322 3001
Fax
Email
Drdashti50@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Atefe Nikjoo
Position
Medical student
Other areas of specialty/work
Street address
Pardis dormitory، College of Medical Sciences and Health Services، Jannat boulevard، Dr Hesabi square، Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 4702
Fax
Email
atefeh.nikjoo@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)