Objectives: To compare the effect of the effect of ketorolac, morphine, and apotel in patients with head trauma.
Design: a triple blind randomized clinical trial.
Setting and conduct: The eligible patients with head trauma who will refer to Besat Hospital during the study period will be enrolled into the trial.
Inclusion criteria: (a) head trauma during 24 hours; (b) age of 20 to 50 years; (c) severity of headache equal to or greater than 4 based on VAS.
Exclusion criteria: (a) decreased consciousness; (b) abnormal neurologic findings; (c) hemorrhagic and pathologic findings in brain CT scan; (d) history of hemorrhagic disorders or using anti-coagulant agents; (e) history of chronic headaches; (f) multiple trauma; (g) sensitivity of drugs or asthma; (h) addiction; (i) pregnancy; (i) renal failure, liver disease, cardiovascular diseases, pulmonary diseases.
Intervention group 1: Single dose infusion of apotel 15 mg/kg in 100 ml normal saline during 15 min.
Intervention group 2: Single dose infusion of ketorolac 30 mg/kg in 100 ml normal saline during 15 min.
Control group: Single dose infusion of morphine 1 mg/kg in 100 ml normal saline during 15 min.
Primary outcome: Measuring the severity of headache before, and 15 and 30 min after intervention using visual analog scale (VAS).
Secondary outcome: Assessing probable drug side effects (such as nausea, vomiting, dizziness, itching) by question 15 and 30 min after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201603089014N94
Registration date:2016-03-27, 1395/01/08
Registration timing:prospective
Last update:
Update count:1
Registration date
2016-03-27, 1395/01/08
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of ketorolac, morphine, and apotel in patients with head trauma: a triple blind randomized clinical trial
Public title
Comparison of the effect of ketorolac, morphine, and apotel in patients with head trauma
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: (a) head trauma during 24 hours; (b) age of 20 to 50 years; (c) severity of headache equal to or greater than 4 based on VAS.
Exclusion criteria: (a) decreased consciousness; (b) abnormal neurologic findings; (c) hemorrhagic and pathologic findings in brain CT scan; (d) history of hemorrhagic disorders or using anti-coagulant agents; (e) history of chronic headaches; (f) multiple trauma; (g) sensitivity of drugs or asthma; (h) addiction; (i) pregnancy; (i) renal failure, liver disease, cardiovascular diseases, pulmonary diseases.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization of 6 group.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-02-27, 1394/12/08
Ethics committee reference number
IR.UMSHA.REC.1394.498
Health conditions studied
1
Description of health condition studied
Head trauma
ICD-10 code
S09
ICD-10 code description
Other and unspecified injuries of head
Primary outcomes
1
Description
Measuring the severity of headache
Timepoint
before, and 15 and 30 min after intervention
Method of measurement
using visual analog scale (VAS)
Secondary outcomes
1
Description
Assessing probable drug side effects (such as nausea, vomiting, dizziness, itching)
Timepoint
15 and 30 min after intervention
Method of measurement
by question
Intervention groups
1
Description
Single dose infusion of apotel 15 mg/kg in 100 ml normal saline during 15 min
Category
Treatment - Drugs
2
Description
Single dose infusion of ketorolac 30 mg/kg in 100 ml normal saline during 15 min
Category
Treatment - Drugs
3
Description
Single dose infusion of morphine 1 mg/kg in 100 ml normal saline during 15 min
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Alireza Azimi Far
Street address
Besat Hospital, Shahed Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Besat Hospital
Full name of responsible person
Dr Alireza Azimi Far
Position
Resident of Emergency Medicine
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
azimi_a1122@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Dr Rasoul Salimi
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
rasoulsl@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)