Actually few studies are available comparing the clinical efficacy of intravenous acetaminophen with other medications such as dexamethasone to decrease postoperative pain and side effects in children. This study has been designed to compare the postoperative side effects in children after tonsillectomy. Participats were randomized to receive either intravenous acetaminophen or dexamethasone. Methods: Eighty four children aged between 1 and 12 years who were candidates for tonsillectomy were randomized using a computer-generated schedule to double-blind treatment with intravenous acetaminophen (15mg/kg) or intravenous dexamethasone (0.1 mg/kg). Children were assessed postoperatively for swallowing pain, pain when opening mouth, ear pain, sore throat, and postoperative nausea and vomiting (PONV) in recovery and on the ward up to 6 hours, as well as at 12 and 24 hours after surgery using visual analogue scale (VAS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208138075N3
Registration date:2012-12-23, 1391/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-23, 1391/10/03
Registrant information
Name
Minoo Sedaghat
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 7141
Email address
m-sedaghat@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-08-31, 1391/06/10
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of intravenous Acetaminophen versus intravenous Dexamethasone on post tonsillectomy pain in children between 1 and 12 years old.
Public title
Effects of acetaminophen on post tonsillectomy pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 84 Patients age between 1-12 years, who candidate for tonsillectomy surgery, American Society of Anesthesiologists (ASA) physical status class I & II
Exclusion criteria:
1 - Chronic pain or daily intake housing
2- A history of seizures
3 - Liver dysfunction or abnormal liver enzymes
4 - Sensitivity to drugs
Age
From 1 year old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In the recovery room, syringe 10 cc medication was ready by a nurse and were labeled A and B. One of which contains 15 mg of intravenous acetaminophen in one cc and the other, 0.1 mg Dexamethasone in one cc. Intravenous acetaminophen brand apotel UNI PHARMA Manufacturing Plant in Greece and brand Dexamethasone is( Iran) Osvah Decadrol construction. At half an hour to the end of tonsillectomy, based on block randomization table 1 cc of A or B for each kilogram of body weight is injected slowly and only once.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of Medical Sciences
Street address
School of Medicine, P.O.BOX: 14155-6447
City
Tehran
Postal code
1417613151
Approval date
2012-12-15, 1391/09/25
Ethics committee reference number
91-03-30-16812-72608
Health conditions studied
1
Description of health condition studied
Hypertrophy of tonsils
ICD-10 code
J35.0
ICD-10 code description
Chronic diseases of tonsils and adenoids
Primary outcomes
1
Description
pain
Timepoint
every 12 hours until 24 hours after surgery
Method of measurement
VAS (visual analogous scale)
Secondary outcomes
1
Description
nausea and vomit
Timepoint
Every12 hours until 24 hours after surgery
Method of measurement
How many time
Intervention groups
1
Description
In group 1: 15mg/kg iv acetaminophen will be administrated at 30 min before the end of the surgery.
Category
Treatment - Drugs
2
Description
In group 2: 0.1 mg/kg iv dexamethasone will be administrated at 30 min before the end of the surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
ENT operating theaters of Firoozgar Hospital
Full name of responsible person
Dr Minow Sedaghat
Street address
Niayesh St., Satarkhan Ave.
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
Dr Akbar Fotohi
Street address
4th Floor, Central Organization of Tehran University of Medical Sciences, Qods Ave., Keshavarz Boulevard
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
Hazrateh Rasul Akram Hospital, Tehran University of Medical Sciences