Burn pain management is a major challenge in treating of these patients. In this randomized single blinded interventional study intravenous acetaminophen and intravenous morphine will be compared for pain management in the burns. 150 patients from 15 to 55 years old with 15% to 50% acute burn and indication of admission will be enrolled to our study. Patients with unstable vital signs, altered mental status and substance abuse will be excluded. The Patients will be selected as random allocation AND consecutive sampling and will be divided into 3 equal (50) groups. The first group on the first day will be received IV acetaminophen and in the second day IV morphine. The second group on the first day will be received IV morphine and in the second day IV acetaminophen and the third group will be received IV morphine in the first and second day. Pain intensity will be measured according to visual analog scale one minute before the injection, 30 and 60 minutes after the injection in each group. The mean pain reduction on VAS before and after injection will be compared in tree groups.
Morphine dosage: 0.1 mg/kg every 6 hours
Acetaminophen dosage: adults over 50 kg: 1 g IV every 6 hours
Adults under 50 kg: 15 mg /kg IV every 6 hours
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101205588N1
Registration date:2011-06-30, 1390/04/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-30, 1390/04/09
Registrant information
Name
Karim Sohrabi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 310 1097
Email address
sohrabi@alborz.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2011-02-04, 1389/11/15
Expected recruitment end date
2011-07-06, 1390/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of Intravenous Acetaminophen versus intravenous morphin in acut burn pain management
Public title
effect of intravenous acetaminophen on pain manegement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Second or more degree of burn;Burn at least 15% total body surface area AND maximum 50% total body surface area;Hospitalization at least for 2 days;Stable vital signs and ASA I AND ASA II conditions.
Exclusion criteria:Drug abuse and addiction;Unstable vital signs; loss of consciousness ;respiratory distress;Pneumothorax or suspicion to that;Bowel obstruction or suspicion to that;Pneumocephalus;Asthma AND COPD AND IHD;Discharged patients by informed consent in less than 2 days of hospitalization;Active chronic liver disease.
Age
From 15 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Tehran University of Medical Sciences
Street address
Crossroad of Hemmat AND Fazl-allah Expway
City
Tehran
Postal code
Approval date
2010-11-23, 1389/09/02
Ethics committee reference number
152
Health conditions studied
1
Description of health condition studied
burn
ICD-10 code
T30.2
ICD-10 code description
Burn of second degree, body region unspecified
2
Description of health condition studied
burn
ICD-10 code
T30.3
ICD-10 code description
Burn of third degree, body region unspecified
3
Description of health condition studied
burn
ICD-10 code
T31.1
ICD-10 code description
Burns involving 10-19% of body surface
4
Description of health condition studied
burn
ICD-10 code
T31.2
ICD-10 code description
Burns involving 20-29% of body surface
5
Description of health condition studied
burn
ICD-10 code
T31.3
ICD-10 code description
Burns involving 30-39% of body surface
6
Description of health condition studied
burn
ICD-10 code
T31.4
ICD-10 code description
Burns involving 40-49% of body surface
7
Description of health condition studied
burn
ICD-10 code
T31.5
ICD-10 code description
Burns involving 50-59% of body surface
Primary outcomes
1
Description
Pain severity
Timepoint
30 minute and 60 minute after analgesic injection
Method of measurement
visual analoge pain scale
Secondary outcomes
empty
Intervention groups
1
Description
intervention: acetaminophen 15mg/kg Max 1000 mg every 6 hours IV for first day and morphine 0.1 mg/kg every 6 hours IV for second day
Category
Treatment - Drugs
2
Description
intervation:morphin 0.1 mg/kg every 6 hours IV for first day and acetamionophen 15 mg/kg Max 1000mg every 6 hours IV for second day
Category
Treatment - Drugs
3
Description
control: morphin 0.1 mg/kg every 6 hours IV for first day and second day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Hospital
Full name of responsible person
Sohrabi Karim MD
Street address
yasemi ave. vali-asr ave. tehran.iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
tehran university of medical sciences
Full name of responsible person
research commitee
Street address
Crossroad of Hemmat AND Fazl-allah Expway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Tehran University of Medical Sciences
Full name of responsible person
Sohrabi Karim MD
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 4433 4806
Fax
Email
sohrabi@alborz.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Salehi Reza MD
Position
assistant professor of anesthesiology department
Other areas of specialty/work
Street address
motahari hospitalTehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
hbgssl@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sohrabi Karim MD
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
Emergency department rasul- akram hospital Tehran University of Medical Sciences
City
Tehran
Postal code
Iran
Phone
+98 21 6652 5327
Fax
-----
Email
sohrabi@alborz.mui.ac.ir
Web page address
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Sharing plan
Deidentified Individual Participant Data Set (IPD)