Post Trauma Headache syndrome is one of several symptoms after trauma. So patients can experience the pain of somatic or psychological, or be the plaintiff. Various studies have been done on the effects of different drugs. Considering that Opioids in trauma patients can have adverse effects on the respiratory system. It can also affect the patient's vital signs, so the aim of the study on the use of intravenous acetaminophen in patients with head trauma and traumatic headache, in base of length and level of becoming symptom free and shot outcome (24 hours).
GCS15 head trauma patients who has pure headache, age between 18 to 65 years and GCS=15 enrolled to this study, patients who is older than 65 or younger than 18, addiction to Opioids and GCS=14 or lower will excluded.
Patients will divided in two groups randomly; according to last studies, each group will have 30 patients. For control group, 0.1 mg/kg Morphin will be infused and for case group 1gr Apotel will be diluted in 100 cc Normal saline and infused in 10 minutes. Before treatment, Headache will be assessed with numeric pain scale and after treatment and 24 hours later also with the same scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204127327N2
Registration date:2012-05-26, 1391/03/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-05-26, 1391/03/06
Registrant information
Name
Samad Shams Vahdati
Name of organization / entity
Tabriz University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 41 1658 1401
Email address
shams@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-05-04, 1391/02/15
Expected recruitment end date
2012-11-05, 1391/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effective comparision of Apotel versus Morphine in reducing of post pure head trauma headache
Public title
Effective comparision of Apotel versus Morphine in reducing of post pure head trauma headache
Purpose
Treatment
Inclusion/Exclusion criteria
All patients with head trauma will be enrolled after obtaining the neourosurgery service examination result that there is no pathologic findings. Patients who have GCS14 or less or are older than 65 or age under 18 years old are excluded
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Tabriz University of Medical Sciences Ethics Committee
Street address
Golgasht street
City
Tabriz
Postal code
Approval date
2012-01-13, 1390/10/23
Ethics committee reference number
5/4/10392
Health conditions studied
1
Description of health condition studied
Traumatic headache
ICD-10 code
g44.3
ICD-10 code description
Chronic post-traumatic headache
Primary outcomes
1
Description
Headache
Timepoint
one week
Method of measurement
Numeric pain scale
Secondary outcomes
1
Description
Hypotension
Timepoint
10min
Method of measurement
Barometer
2
Description
Hypoxemia
Timepoint
10 min
Method of measurement
puls oximetry
Intervention groups
1
Description
In intervention group, 1 gr Apotel will be diluted in 100 cc normal saline and be infused in 10 minutes
Category
Treatment - Drugs
2
Description
In control group, 0.1mg/kg Morphine will be infused
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Street address
golgasht street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Ali meshkini
Street address
Deputy of research, Faculty of Medicine, Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Samad shams Vahdati
Position
Assistant professor
Other areas of specialty/work
Street address
Golghasht street, Imam reza hospital, Emergency department
City
Tabriz
Postal code
Phone
+98 41 1335 2078
Fax
Email
shams@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Samad Shams Vahdati
Position
Assisatnt professor
Other areas of specialty/work
Street address
Daneshghah street
City
Tabriz
Postal code
Phone
+98 41 1335 2078
Fax
Email
shamsv@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)