Protocol summary
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Study aim
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To compare the effect of the effect of ketorolac, morphine, and apotel in patients with head trauma
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Design
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A double blind randomized clinical trial
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Settings and conduct
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The eligible patients with head trauma who will refer to Besat Hospital of hamadan City during the study period will be enrolled into the trial and will be randomly assigned to the intervention and control groups.
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Participants/Inclusion and exclusion criteria
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]nclusion criteria: (a) head trauma during 24 hours; (b) age of 15to 50 years; (c) severity of a 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) asthma; (h) addiction; (i) pregnancy; (i) renal failure, liver disease, cardiovascular diseases, pulmonary diseases
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Intervention groups
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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 in 100 ml normal saline during 15 min.
Control group: Single dose infusion of morphine 0.1 mg in 100 ml normal saline during 15 min.
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Main outcome variables
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Primary outcome: Measuring the severity of a headache before, and 15 and 30 and 60 min after intervention using a visual analog scale (VAS).
Secondary outcome: Assessing probable drug side effects (such as nausea, vomiting, dizziness, itching) by question 15 and 30 and 60 min after the intervention.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201603089014N94
Registration date:
2016-03-27, 1395/01/08
Registration timing:
prospective
Last update:
2018-12-10, 1397/09/19
Update count:
1
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Registration date
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2016-03-27, 1395/01/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
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Expected recruitment start date
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2016-04-20, 1395/02/01
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Expected recruitment end date
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2017-03-19, 1395/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effect of ketorolac, morphine, and apotel in patients with head trauma: a double-blind randomized clinical trial
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Public title
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Comparison of the effect of ketorolac, morphine, and apotel in patients with head trauma
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
age of 15 to 50 years;
head trauma during 24 hours
severity of headache equal to or greater than 4 based on VAS
Exclusion criteria:
Decreased consciousness
Abnormal neurologic findings
Hemorrhagic and pathologic findings in brain CT scan
A history of hemorrhagic disorders or using anti-coagulant agents
A history of chronic headaches
Multiple trauma
Asthma
Addiction
Pregnancy
Renal failure, liver disease, cardiovascular diseases, pulmonary diseases
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Age
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From 20 years old to 50 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
105
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Medications will be prepared the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double-blind
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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.
Ethics committees
1
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Ethics committee
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Approval date
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2016-02-27, 1394/12/08
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Ethics committee reference number
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IR.UMSHA.REC.1394.498
Health conditions studied
1
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Description of health condition studied
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Head trauma
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ICD-10 code
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S09
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ICD-10 code description
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Other and unspecified injuries of head
Primary outcomes
1
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Description
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Measuring the severity of headache
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Timepoint
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before, and 15 and 30 min after intervention
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Method of measurement
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using visual analog scale (VAS)
Secondary outcomes
1
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Description
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Assessing probable drug side effects (such as nausea, vomiting, dizziness, itching)
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Timepoint
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15 and 30 min after intervention
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Method of measurement
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by question
Intervention groups
1
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Description
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Single dose infusion of apotel 15 mg/kg in 100 ml normal saline during 15 min
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Category
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Treatment - Drugs
2
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Description
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Single dose infusion of ketorolac 30 mg/kg in 100 ml normal saline during 15 min
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Category
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Treatment - Drugs
3
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Description
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Single dose infusion of morphine 1 mg/kg in 100 ml normal saline during 15 min
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available