Protocol summary

Summary
The main objective of this study is to determine the difference between Acetaminophen and Ibuprofen in pain relief following Adenotonsillectomy in children. The study has been designed as a Randomized Clinical Trial which is triple blind with no placebo control group in a single research center.Population which has been chosen as our study instant children are, belong to the range of 4 to 10 years old groups. Inclusion criteria: 1. No Allergy to Non Steroid Anti-Inflammatory Drugs 2. No History of coagulopathy 3. No Renal or Hepatic disorder 4. No Severe Asthma (recently admission or treatment with oral corticosteroid) 5. No Family history of coagulopathy 6. No Evidence of Mental retardation Exclusion criteria: 1. Severe and uncontrollable bleeding during and after surgery 2. Severe pain after surgery which needs additional analgesic Sample size is 50 individuals that are randomly assigned them to two equal groups. Intervention in each group is defined as either administration of Acetaminophen or Ibuprofen . The outcomes of study are: 1. Pain score after surgery ( after 6 hours postoperative, after 24 hour, after 48 hour ) 2. The number of episodes of nausea and vomiting after surgery ( during first day, during first week ) 3. Intraoperative bleeding volume 4. Postoperative bleeding ( during first day, during first week ) 5. Time to start eating of oral liquids, semisolid and solid foods 6. Time to going back to their normal life 7. Overall satisfaction of recovery

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013071814047N1
Registration date: 2013-11-07, 1392/08/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-11-07, 1392/08/16
Registrant information
Name
Fatemeh Mirashrafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1628
Email address
f-mirashrafi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-12-01, 1392/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Acetaminophen and Ibuprofen in pain relief and complication management following Adenotonsillectomy in 4-10 year old children.
Public title
Comparison of the effect of Acetaminophen and Ibuprofen in pain relief following Adenotonsillectomy.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1- No Allergy to Non Steroid Anti-Inflammatory Drugs 2- No History of coagulopathy 3- No Renal and Hepatic disorder 4- No Severe Asthma (recently admission or treatment with oral corticosteroid) 5- No Family history of coagulopathy 6- No Evidence of Mental retardation Exclusion Criteria: 1- Severe and uncontrollable bleeding during and after surgery 2- Severe pain after surgery which needs additional analgesic
Age
From 4 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study has been called triple blind. Treatment allocation is revealed neither to patients nor to the researcher who fills out the questionnaires. In addition the individuals who access the data do not know which treatment is assigned to each patient.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Sixth floor, central organization of University, next to Ghods Ave, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2012-07-11, 1391/04/21
Ethics committee reference number
673/130/د/91

Health conditions studied

1

Description of health condition studied
Adenotonsillectomy
ICD-10 code
J35.1,J35.
ICD-10 code description
Enlargement of tonsils, Enlargement of adenoids

Primary outcomes

1

Description
Pain score
Timepoint
Six hours postoperative, at the end of first postoperative day, at the end of second postoperative day
Method of measurement
with visual analogue pain scale (1-10 score)

Secondary outcomes

1

Description
Intraoperative bleeding volume
Timepoint
During the surgery
Method of measurement
Amount of bleeding in CC, according to the number of sterile gases that is used during the surgery and amount of blood at suction bottle

2

Description
Bleeding at the first postoperative day
Timepoint
At the end of the first postoperative day
Method of measurement
questionnaire

3

Description
Bleeding during the first postoperative week
Timepoint
At the end of first postoperative week
Method of measurement
questionnaire

4

Description
Nausea
Timepoint
At the end of first postoperative day and at the end of first postoperative week
Method of measurement
questionnaire

5

Description
Vomiting
Timepoint
At the end of first postoperative day and at the end of first postoperative week
Method of measurement
questionnaire

6

Description
Time to start eating of oral liquids
Timepoint
At the end of first postoperative week
Method of measurement
questionnaire

7

Description
Time to start eating of semisolid foods
Timepoint
At the end of first postoperative week
Method of measurement
questionnaire

8

Description
Time to start eating of solid foods
Timepoint
At the end of first postoperative week
Method of measurement
questionnaire

9

Description
Time to going back to their normal life
Timepoint
At the end of first postoperative week
Method of measurement
questionnaire

10

Description
Overall satisfaction of recovery
Timepoint
At the end of first postoperative week
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group 1: Syrup Ibuprofen 10mg/ kg orally, once an hour before surgery and then every 6 hour for 3 days was used. This syrup manufacturing company is Hakim co. in Iran and its concentration is 100 mg per 5 ml.
Category
Treatment - Drugs

2

Description
Intervention group 2: Syrup Acetaminophen 15mg/ kg orally, once an hour before surgery and then every 6 hours for 3 days was used. This syrup manufacturing company is Kimidaru co. in Iran and its concentration is 120 mg per 5 ml.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Children’s Medical Center
Full name of responsible person
Fatemeh Mirashrafi
Street address
No. 62, next to Imam Khomeini Hospital, Dr. Mohammad Gharib Ave., Keshavarz Blvd.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
No. 1, Poursina Ave., Qods Ave., Enghelab Ave.
City
Tehran
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, Tehran 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
ENT research center, Imam Khomeini Hospital
Full name of responsible person
Fatemeh Mirashrafi
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Dr. Mohammad Gharib Ave., Keshavarz Blvd., Enghelab St.
City
Tehran
Postal code
Phone
+98 21 6658 1628
Fax
Email
f-mirashrafi@sina.tums.ac.ir
Web page address
http://ikh.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
ENT research center, Imam Khomeini Hospital
Full name of responsible person
Fatemeh Mirashrafi
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Dr. Mohammad Gharib Ave., Keshavarz Blvd., Enghelab St.
City
Tehran
Postal code
Phone
+98 21 6658 1628
Fax
Email
f-mirashrafi@sina.tums.ac.ir
Web page address
http://ikh.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Tavakolnejad
Position
Medical student
Other areas of specialty/work
Street address
No. 1, Poursina Ave., Qods St., Enghelab St.
City
Tehran
Postal code
Phone
+98 21 8861 2783
Fax
Email
f.tavakolnejad@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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