In the present study, the effects of intravenous administration of intralipid in treatment of acute tramadol poisoning will be assessed. Te patients in case group will be received a vial of intralipid 20% upon arrival to the hospital. The patients in control group will not received it. Both groups will be undertaken other standard management included GI decontamination, supportive measures, and therapy for possible convulsion. the groups will be compared for the severity and/or duration of clinical and lab symptoms and signs, and duration of hospital admission.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050120951N3
Registration date:2017-05-29, 1396/03/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-29, 1396/03/08
Registrant information
Name
Amir Mohammad Kazemifar
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 6696
Email address
amkazemifar@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
The Research Office of Qazvin's Faculty of Medicine
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Intravenous fat emulsion (Intralipid) in treatment of acute tramadol poisoning
Public title
Intralipid in treatment of tramadol poioiiong
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: history of tramadol poisoning, presence of pertinent clinical signs and symptoms, consent for participation in the study
Exclusion: co-ingestion, history of hypersensitivity to the drug, presence of a major internal disease
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin's University of Medical Sciences
Street address
Bahonar Bolvd.
City
Qazvn
Postal code
Approval date
2017-02-11, 1395/11/23
Ethics committee reference number
28/20/13399
Health conditions studied
1
Description of health condition studied
Acute tramadol poisoning
ICD-10 code
T40
ICD-10 code description
Poisoning by narcotics and psychodysleptics [hallucinogens]
Primary outcomes
1
Description
convulsion
Timepoint
at the time of admission and during hospital stay
Method of measurement
observation by nurse or physician
2
Description
duration of hospitalization
Timepoint
at the time of discharge
Method of measurement
according to the hospital records
Secondary outcomes
1
Description
systolic blood pressure
Timepoint
during hospital admission
Method of measurement
sphygnomanimeter
2
Description
diastolic blood pressure
Timepoint
during hospital admission
Method of measurement
sphygnomanimeter
3
Description
heart rate
Timepoint
during hospital admission
Method of measurement
by nurse or phycician
4
Description
serum CPK level
Timepoint
at he time of admission and 24 hours later
Method of measurement
by lab
Intervention groups
1
Description
case group: Intralipid 20% 500 cc infusion in 1-2 hours
Category
Treatment - Drugs
2
Description
control group: no drug
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Buali hospital
Full name of responsible person
Abbas Bedram
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mjanaz Abbasi
Street address
Bahonar Blvd
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of medical Sciences
Full name of responsible person
Amir Mohammad Kazemifar
Position
faculty member
Other areas of specialty/work
Street address
Buali hospital
City
Qazvin
Postal code
Phone
+98 28 3333 2930
Fax
Email
amkazemifar@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Mohammad Kazemifar
Position
Faculty member
Other areas of specialty/work
Street address
Buali hospital
City
Qazvin
Postal code
Phone
+98 28 3333 2930
Fax
Email
amkazemifar@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Mohammad Kazemifar
Position
Faculty member
Other areas of specialty/work
Street address
Buali hospital
City
Qazvin
Postal code
Phone
+98 28 3333 2930
Fax
Email
amkazemifar@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)