Adenotonsillectomy is the most common surgical procedure in children. One of the most common complications of this surgery is pain that is associated with prolonged recovery, disorders in eating and dehydration. For pain relief various drugs and techniques are used.
The aim of this study is the clinical effectiveness comparing between intravenous and rectal acetaminophen.
For this reason in a patient – observer blind randomized clinical trial 96 patients from 4 to 10 years old that scheduled for adenotonsillectomy will select ( after explaining the process of the trial written informed consent obtained from participants)
Then they will divide into two groups randomly, and after induction of general anesthesia the first group rectal will receive acetaminophen 15mg/kg and second group will receive intravenous acetaminophen 10 mg/kg will receive.
Agitation and pain ( with chipps score) will be recorded and then analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107301138N8
Registration date:2011-08-11, 1390/05/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-08-11, 1390/05/20
Registrant information
Name
Fataneh Bakhshi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 8307
Email address
entrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences, Vice chancellor for Research
Expected recruitment start date
2011-08-01, 1390/05/10
Expected recruitment end date
2011-11-21, 1390/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of intravenous and rectal acetaminophen on duration of pain control after adenotonsillectomy in children
Public title
Comparison the effects of acetaminophen on pain control after adenotonsillectomy in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patirnts candidate for elective adenotonsillectomy surgery (4 – 10 yr); ASA claa I , II
Exclusion criteria:emergency surgery; history of the known sensitivity to acetaminophen; history of liver, renal, respiratory , cardiac diseases, seizure; history of chronic pain with usage of analgesics
Age
From 4 years old to 10 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Guilan University of Medical Sciences
Street address
Siadati st.
City
Rasht
Postal code
Approval date
2011-05-31, 1390/03/10
Ethics committee reference number
624
Health conditions studied
1
Description of health condition studied
adenotonsillectomy
ICD-10 code
T 17.2
ICD-10 code description
Nasopharynx
Primary outcomes
1
Description
Post operative pain
Timepoint
from beginning of recovery every 15 minutes , in the first 6 hours every 2 hours then up to 24 hours, every 6 hours
Method of measurement
With table
Secondary outcomes
1
Description
Agitation
Timepoint
from beginning of post anesthesia car unit every 15 minutes , in the first 6 hours every 2 hours, then up to 24 hours, every 6 hours
Method of measurement
With scoring table
Intervention groups
1
Description
Group A) Intravenous Acetaminophen (10mg/kg)
Category
Treatment - Drugs
2
Description
Group B) Rectal Acetaminophen (125,250mg)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Susan Komaii
Street address
First Floor, University Building, Siadati st.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences, Vice Chancellor 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
Guilan University of Medical Sciences
Full name of responsible person
Dr Sudabeh Haddadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Amiralmomenin hospital, 17 Shahriva st.
City
Rasht
Postal code
Phone
+98 13 1222 5242
Fax
Email
so_haddadi@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Sudabeh Haddadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Amiralmomenin hospital, 17 Shahrivar st.
City
Rasht
Postal code
Phone
+98 13 1222 5242
Fax
Email
so_haddadi@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)