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Protocol summary
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.
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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.
اهداف: مقایسه اثر ضد دردی کتورولاک، مورفین و آپوتل در بیماران ترومای سر.
طراحی: کارآزمایی بالینی تصادفی شده سه سو کور.
نحوه انجام: بیماران مبتلا به ترومای سر که در طول مطالعه به بیمارستان بعثت مراجعه نمایند در صورت واجد شرایط بودن وارد مطالعه خواهند شد.
شرایط ورود: (الف) تروما به سر طی 24 ساعت قبل؛ (ب) سن 20 تا 50 سال؛ (ج) دارای سردرد با شدت 4 یا بیشتر بر اساس مقیاس آنالوگ دیداری.
شرایط خروج: (الف) کاهش سطح هوشیاری؛ (ب) یافته های نورولوژیک غیر طبیعی؛ (ج) شواهد خونریزی و ضایعه پاتولوژیک در سی تی اسکن مغزی؛ (د) سابقه مشکلات انعقادی یا مصرف داروهای ضد انعقاد؛ (ه) سابقه قبلی سردرد های مزمن؛ (و) تروماهای متعدد؛ (ز) سابقه حساسیت دارویی و آسم؛ (ح) اعتیاد؛ (ط) بارداری؛ (ی) بیماری کلیوی،کبدی، قلبی و ریوی.
گروه مداخله 1: انفوزیون آپوتل یک نوبت با دوز 15 میلی گرم بر کیلوگرم در 100 میلی لیتر سرم نرمال سالین طی 15 دقیقه.
گروه مداخله 2: انفوزیون کتورولاک یک نوبت دوز 30 میلی گرم بر کیلوگرم در 100 میلی لیتر سرم نرمال سالین طی 15 دقیقه.
گروه کنترل: انفوزیون مورفین یک نوبت دوز 1 میلی گرم بر کیلوگرم در 100 میلی لیتر سرم نرمال سالین طی 15 دقیقه.
پیامد اولیه: اندازه گیری شدت سردرد با استفاده از مقیاس آنالوگ دیداری قبل از مداخله و 15 و 30 دقیقه بعد از مداخله.
پیامد ثانویه: بررسی عوارض احتمالی دارو (شامل تهوع و استفراغ، سرگیجه، و خارش) با پرسش از بیمار 15 و 30 دقیقه بعد از مداخله.
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اهداف: مقایسه اثر ضد دردی کتورولاک، مورفین و آپوتل در بیماران ترومای سر. طراحی: کارآزمایی بالینی تصادفی شده سه سو کور. نحوه انجام: بیماران مبتلا به ترومای سر که در طول مطالعه به بیمارستان بعثت مراجعه نمایند در صورت واجد شرایط بودن وارد مطالعه خواهند شد. شرایط ورود: (الف) تروما به سر طی 24 ساعت قبل؛ (ب) سن 20 تا 50 سال؛ (ج) دارای سردرد با شدت 4 یا بیشتر بر اساس مقیاس آنالوگ دیداری. شرایط خروج: (الف) کاهش سطح هوشیاری؛ (ب) یافته های نورولوژیک غیر طبیعی؛ (ج) شواهد خونریزی و ضایعه پاتولوژیک در سی تی اسکن مغزی؛ (د) سابقه مشکلات انعقادی یا مصرف داروهای ضد انعقاد؛ (ه) سابقه قبلی سردرد های مزمن؛ (و) تروماهای متعدد؛ (ز) سابقه حساسیت دارویی و آسم؛ (ح) اعتیاد؛ (ط) بارداری؛ (ی) بیماری کلیوی،کبدی، قلبی و ریوی. گروه مداخله 1: انفوزیون آپوتل یک نوبت با دوز 15 میلی گرم بر کیلوگرم در 100 میلی لیتر سرم نرمال سالین طی 15 دقیقه. گروه مداخله 2: انفوزیون کتورولاک یک نوبت دوز 30 میلی گرم بر کیلوگرم در 100 میلی لیتر سرم نرمال سالین طی 15 دقیقه. گروه کنترل: انفوزیون مورفین یک نوبت دوز 1 میلی گرم بر کیلوگرم در 100 میلی لیتر سرم نرمال سالین طی 15 دقیقه. پیامد اولیه: اندازه گیری شدت سردرد با استفاده از مقیاس آنالوگ دیداری قبل از مداخله و 15 و 30 دقیقه بعد از مداخله. پیامد ثانویه: بررسی عوارض احتمالی دارو (شامل تهوع و استفراغ، سرگیجه، و خارش) با پرسش از بیمار 15 و 30 دقیقه بعد از مداخله.
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To compare the effect of the effect of ketorolac, morphine, and apotel in patients with head trauma
To compare the effect of the effect of ketorolac, morphine, and apotel in patients with head trauma
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مقایسه اثر ضد دردی کتورولاک، مورفین و آپوتل در بیماران ترومای سر
مقایسه اثر ضد دردی کتورولاک، مورفین و آپوتل در بیماران ترومای سر
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A double blind randomized clinical trial
A double blind randomized clinical trial
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کارآزمایی بالینی تصادفی شده دو سو کور
کارآزمایی بالینی تصادفی شده دو سو کور
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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.
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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بیماران مبتلا به ترومای سر که در طول مطالعه به بیمارستان بعثت شهر همدان مراجعه نمایند در صورت واجد شرایط بودن وارد مطالعه خواهند شد و به صورت تصادفی به دو گروه مداخله و کنترل تخصیص داده خواهند شد.
بیماران مبتلا به ترومای سر که در طول مطالعه به بیمارستان بعثت شهر همدان مراجعه نمایند در صورت واجد شرایط بودن وارد مطالعه خواهند شد و به صورت تصادفی به دو گروه مداخله و کنترل تخصیص داده خواهند شد.
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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
]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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شرایط ورود: (الف) تروما به سر طی 24 ساعت قبل؛ (ب) سن 15 تا 50 سال؛ (ج) دارای سردرد با شدت 4 یا بیشتر بر اساس مقیاس آنالوگ دیداری.
شرایط خروج: (الف) کاهش سطح هوشیاری؛ (ب) یافته های نورولوژیک غیر طبیعی؛ (ج) شواهد خونریزی و ضایعه پاتولوژیک در سی تی اسکن مغزی؛ (د) سابقه مشکلات انعقادی یا مصرف داروهای ضد انعقاد؛ (ه) سابقه قبلی سردرد های مزمن؛ (و) تروماهای متعدد؛ (ز) آسم؛ (ح) اعتیاد؛ (ط) بارداری؛ (ی) بیماری کلیوی،کبدی، قلبی و ریوی
شرایط ورود: (الف) تروما به سر طی 24 ساعت قبل؛ (ب) سن 15 تا 50 سال؛ (ج) دارای سردرد با شدت 4 یا بیشتر بر اساس مقیاس آنالوگ دیداری. شرایط خروج: (الف) کاهش سطح هوشیاری؛ (ب) یافته های نورولوژیک غیر طبیعی؛ (ج) شواهد خونریزی و ضایعه پاتولوژیک در سی تی اسکن مغزی؛ (د) سابقه مشکلات انعقادی یا مصرف داروهای ضد انعقاد؛ (ه) سابقه قبلی سردرد های مزمن؛ (و) تروماهای متعدد؛ (ز) آسم؛ (ح) اعتیاد؛ (ط) بارداری؛ (ی) بیماری کلیوی،کبدی، قلبی و ریوی
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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.
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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گروه مداخله 1: انفوزیون آپوتل یک نوبت با دوز 15 میلی گرم بر کیلوگرم در 100 میلی لیتر سرم نرمال سالین طی 15 دقیقه.
گروه مداخله 2: انفوزیون کتورولاک یک نوبت دوز 30 میلی گرم در 100 میلی لیتر سرم نرمال سالین طی 15 دقیقه.
گروه کنترل: انفوزیون مورفین یک نوبت دوز 0.1 میلی گرم در 100 میلی لیتر سرم نرمال سالین طی 15 دقیقه
گروه مداخله 1: انفوزیون آپوتل یک نوبت با دوز 15 میلی گرم بر کیلوگرم در 100 میلی لیتر سرم نرمال سالین طی 15 دقیقه. گروه مداخله 2: انفوزیون کتورولاک یک نوبت دوز 30 میلی گرم در 100 میلی لیتر سرم نرمال سالین طی 15 دقیقه. گروه کنترل: انفوزیون مورفین یک نوبت دوز 0.1 میلی گرم در 100 میلی لیتر سرم نرمال سالین طی 15 دقیقه
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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.
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.
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پیامد اولیه: اندازه گیری شدت سردرد با استفاده از مقیاس آنالوگ دیداری قبل از مداخله و 15 و 30 و 60 دقیقه بعد از مداخله.
پیامد ثانویه: بررسی عوارض احتمالی دارو (شامل تهوع و استفراغ، سرگیجه، و خارش) با پرسش از بیمار 15 و 30 و 60 دقیقه بعد از مداخله.
پیامد اولیه: اندازه گیری شدت سردرد با استفاده از مقیاس آنالوگ دیداری قبل از مداخله و 15 و 30 و 60 دقیقه بعد از مداخله. پیامد ثانویه: بررسی عوارض احتمالی دارو (شامل تهوع و استفراغ، سرگیجه، و خارش) با پرسش از بیمار 15 و 30 و 60 دقیقه بعد از مداخله.
General information
Triple blinded
Double blinded
tripldoubl
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Comparison of the effect of ketorolac, morphine, and apotel in patients with head trauma: a triple blind randomized clinical trial
Comparison of the effect of ketorolac, morphine, and apotel in patients with head trauma: a double-blind randomized clinical trial
Comparison of the effect of ketorolac, morphine, and apotel in patients with head trauma: a triple double-blind randomized clinical trial
مقایسه اثر ضد دردی کتورولاک، مورفین و آپوتل در بیماران ترومای سر: مطالعه کارآزمایی بالینی سه سو کور
مقایسه اثر ضد دردی کتورولاک، مورفین و آپوتل در بیماران ترومای سر: مطالعه کارآزمایی بالینی دو سو کور
مقایسه اثر ضد دردی کتورولاک، مورفین و آپوتل در بیماران ترومای سر: مطالعه کارآزمایی بالینی سهدو سو کور
age of 15 to 50 years;
head trauma during 24 hours
severity of headache equal to or greater than 4 based on VAS
age of 15 to 50 years; head trauma during 24 hours severity of headache equal to or greater than 4 based on VAS
سن 15تا 50 سال
تروما به سر طی 24 ساعت قبل
دارای سردرد با شدت 4 یا بیشتر بر اساس مقیاس آنالوگ دیداری
سن 15تا 50 سال تروما به سر طی 24 ساعت قبل دارای سردرد با شدت 4 یا بیشتر بر اساس مقیاس آنالوگ دیداری
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
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
کاهش سطح هوشیاری
یافته های نورولوژیک غیر طبیعی
شواهد خونریزی و ضایعه پاتولوژیک در سی تی اسکن مغزی
سابقه مشکلات انعقادی یا مصرف داروهای ضد انعقاد
سابقه قبلی سردرد های مزمن
تروماهای متعدد
آسم
اعتیاد
بارداری
بیماری کلیوی،کبدی، قلبی و ریوی
کاهش سطح هوشیاری یافته های نورولوژیک غیر طبیعی شواهد خونریزی و ضایعه پاتولوژیک در سی تی اسکن مغزی سابقه مشکلات انعقادی یا مصرف داروهای ضد انعقاد سابقه قبلی سردرد های مزمن تروماهای متعدد آسم اعتیاد بارداری بیماری کلیوی،کبدی، قلبی و ریوی
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.
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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.
روش تصادفی سازی: تخصیص تصادفی بیماران به گروه مداخله و کنترل به روش بلوك هاي تصادفي شش تایی.
روش کورسازی: بیمار از نوع مداخله اطلاعی نخواهد داشت. همچنین پزشک معاینه کننده بیماران از نوع مداخله اطلاعی نخواهد داشت. تحلیل کننده دادهها از نوع مداخله اطلاعی نخواهد داشت. لذا مطالعه به صورت سه سو کور اجرا خواهد شد.
روش تصادفی سازی: تخصیص تصادفی بیماران به گروه مداخله و کنترل به روش بلوك هاي تصادفي شش تایی. روش کورسازی: بیمار از نوع مداخله اطلاعی نخواهد داشت. همچنین پزشک معاینه کننده بیماران از نوع مداخله اطلاعی نخواهد داشت. تحلیل کننده دادهها از نوع مداخله اطلاعی نخواهد داشت. لذا مطالعه به صورت سه سو کور اجرا خواهد شد.
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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.
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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تخصیص تصادفی بیماران به گروههای مداخله و کنترل به صورت قرعه کشی. برای این منظور دو برگه تهیه می کنیم روی یکی "مداخله" و روی دیگری "کنترل" می نویسیم. سپس با مراجعه هر بیمار، یکی از برگه ها به صورت تصادفی برداشته و بیمار را به گروه مداخله یا کنترل اختصاص می دهیم
تخصیص تصادفی بیماران به گروههای مداخله و کنترل به صورت قرعه کشی. برای این منظور دو برگه تهیه می کنیم روی یکی "مداخله" و روی دیگری "کنترل" می نویسیم. سپس با مراجعه هر بیمار، یکی از برگه ها به صورت تصادفی برداشته و بیمار را به گروه مداخله یا کنترل اختصاص می دهیم
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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
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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داروها به صورت یکسان تهیه خواهند شد. بنابراین بیمار از نوع مداخله اطلاعی نخواهد داشت. همچنین پزشک معاینه کننده بیماران از نوع مداخله اطلاعی نخواهد داشت. لذا مطالعه به صورت دو سو کور اجرا خواهد شد
داروها به صورت یکسان تهیه خواهند شد. بنابراین بیمار از نوع مداخله اطلاعی نخواهد داشت. همچنین پزشک معاینه کننده بیماران از نوع مداخله اطلاعی نخواهد داشت. لذا مطالعه به صورت دو سو کور اجرا خواهد شد
Recruitment centers
#1
Name of recruitment center - English: Besat Hospital
Name of recruitment center - Persian: بیمارستان بعثت
Full name of responsible person - English: Dr Alireza Azimi Far
Full name of responsible person - Persian: دکتر علیرضا عظیمی فر
Street address - English: Besat Hospital, Shahed Square
Street address - Persian: میدان شاهد، بیمارستان بعثت
City - English: Hamadan
City - Persian: همدان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Besat Hospital
Name of recruitment center - Persian: بیمارستان بعثت
Full name of responsible person - English: Dr Alireza Azimi Far
Full name of responsible person - Persian: دکتر علیرضا عظیمی فر
Street address - English: Besat Hospital, Shahed Square
Street address - Persian: میدان شاهد، بیمارستان بعثت
City - English: Hamadan
City - Persian: همدان
Province: Hamadan
Country: Iran (Islamic Republic of)
Postal code: 6517838695
Phone: +98 81 3838 0572
Fax:
Email: info.research@umsha.ac.ir
Web page address:
Name of recruitment center - English: Besat Hospital Name of recruitment center - Persian: بیمارستان بعثت Full name of responsible person - English: Dr Alireza Azimi Far Full name of responsible person - Persian: دکتر علیرضا عظیمی فر Street address - English: Besat Hospital, Shahed Square Street address - Persian: میدان شاهد، بیمارستان بعثت City - English: Hamadan City - Persian: همدان Province: Hamadan Country: Iran (Islamic Republic of) Postal code: 6517838695 Phone: +98 81 3838 0572 Fax: Email: info.research@umsha.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Name of organization / entity - Persian: معاونت تحقيقات و فناوري دانشگاه علوم پزشكي همدان
Full name of responsible person - English: Dr Saeid Bashirian
Full name of responsible person - Persian: دکتر سعید بشیریان
Street address - English: Hamadan University of Medical Sciences, Shahid Fahmideh Ave
Street address - Persian: خيابان شهيد فهميده، دانشگاه علوم پزشكي همدان
City - English: Hamadan
City - Persian: همدان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Name of organization / entity - Persian: معاونت تحقيقات و فناوري دانشگاه علوم پزشكي همدان
Full name of responsible person - English: Dr Saeid Bashirian
Full name of responsible person - Persian: دکتر سعید بشیریان
Street address - English: Hamadan University of Medical Sciences, Shahid Fahmideh Ave
Street address - Persian: خيابان شهيد فهميده، دانشگاه علوم پزشكي همدان
City - English: Hamadan
City - Persian: همدان
Province: Hamadan
Country: Iran (Islamic Republic of)
Postal code: 6517838695
Phone: +98 81 3838 0572
Fax:
Email: info.research@umsha.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Name of organization / entity - Persian: معاونت تحقيقات و فناوري دانشگاه علوم پزشكي همدان Full name of responsible person - English: Dr Saeid Bashirian Full name of responsible person - Persian: دکتر سعید بشیریان Street address - English: Hamadan University of Medical Sciences, Shahid Fahmideh Ave Street address - Persian: خيابان شهيد فهميده، دانشگاه علوم پزشكي همدان City - English: Hamadan City - Persian: همدان Province: Hamadan Country: Iran (Islamic Republic of) Postal code: 6517838695 Phone: +98 81 3838 0572 Fax: Email: info.research@umsha.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Besat Hospital
Name of organization / entity - Persian: بیمارستان بعثت
Full name of responsible person - English: Dr Alireza Azimi Far
Full name of responsible person - Persian: دکتر علیرضا عظیمی فر
Position - English: Resident of Emergency Medicine
Position - Persian: دستیار طب اورژانس
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Besat Hospital, Shahed Square
Street address - Persian: میدان شاهد، بیمارستان بعثت
City - English: Hamadan
City - Persian: همدان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 81 3364 0030
Mobile: 00
Fax:
Email: azimi_a1122@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Besat Hospital
Name of organization / entity - Persian: بیمارستان بعثت
Full name of responsible person - English: Dr Alireza Azimi Far
Full name of responsible person - Persian: دکتر علیرضا عظیمی فر
Position - English: Resident of Emergency Medicine
Position - Persian: دستیار طب اورژانس
Latest degree: med_doctor
Area of specialty/work: 57
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Besat Hospital, Shahed Square
Street address - Persian: میدان شاهد، بیمارستان بعثت
City - English: Hamadan
City - Persian: همدان
Province: Hamadan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6517838695
Phone: +98 81 3364 0030
Mobile: +98 918 687 5542
Fax:
Email: azimi_a1122@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Besat Hospital Name of organization / entity - Persian: بیمارستان بعثت Full name of responsible person - English: Dr Alireza Azimi Far Full name of responsible person - Persian: دکتر علیرضا عظیمی فر Position - English: Resident of Emergency Medicine Position - Persian: دستیار طب اورژانس Latest degree: med_doctor Area of specialty/work: 057 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Besat Hospital, Shahed Square Street address - Persian: میدان شاهد، بیمارستان بعثت City - English: Hamadan City - Persian: همدان Province: Hamadan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6517838695 Phone: +98 81 3364 0030 Mobile: 00+98 918 687 5542 Fax: Email: azimi_a1122@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Besat Hospital
Name of organization / entity - Persian: بیمارستان بعثت
Full name of responsible person - English: Dr Rasoul Salimi
Full name of responsible person - Persian: دکتر رسول سلیمی
Position - English: Emergency Medicine Specialist
Position - Persian: متخصص طب اورژانس
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Besat Hospital, Shahed Square
Street address - Persian: میدان شاهد، بیمارستان بعثت
City - English: Hamadan
City - Persian: همدان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 81 3364 0030
Mobile: 00
Fax:
Email: rasoulsl@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Besat Hospital
Name of organization / entity - Persian: بیمارستان بعثت
Full name of responsible person - English: Dr Rasoul Salimi
Full name of responsible person - Persian: دکتر رسول سلیمی
Position - English: Emergency Medicine Specialist
Position - Persian: متخصص طب اورژانس
Latest degree: med_doctor
Area of specialty/work: 57
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Besat Hospital, Shahed Square
Street address - Persian: میدان شاهد، بیمارستان بعثت
City - English: Hamadan
City - Persian: همدان
Province: Hamadan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6517838695
Phone: +98 81 3364 0030
Mobile: +98 918 687 5542
Fax:
Email: rasoulsl@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Besat Hospital Name of organization / entity - Persian: بیمارستان بعثت Full name of responsible person - English: Dr Rasoul Salimi Full name of responsible person - Persian: دکتر رسول سلیمی Position - English: Emergency Medicine Specialist Position - Persian: متخصص طب اورژانس Latest degree: med_doctor Area of specialty/work: 057 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Besat Hospital, Shahed Square Street address - Persian: میدان شاهد، بیمارستان بعثت City - English: Hamadan City - Persian: همدان Province: Hamadan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6517838695 Phone: +98 81 3364 0030 Mobile: 00+98 918 687 5542 Fax: Email: rasoulsl@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Department of Epidemiology
Name of organization / entity - Persian: گروه اپيدميولوژي
Full name of responsible person - English: Dr Jalal Poorolajal
Full name of responsible person - Persian: دکتر جلال پورالعجل
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشكي همدان، دانشكده بهداشت
City - English: Hamadan
City - Persian: همدان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6517838695
Phone: +98 81 3838 0090
Mobile: 00
Fax:
Email: poorolajal@umsha.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Department of Epidemiology
Name of organization / entity - Persian: گروه اپيدميولوژي
Full name of responsible person - English: Dr Jalal Poorolajal
Full name of responsible person - Persian: دکتر جلال پورالعجل
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 2
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشكي همدان، دانشكده بهداشت
City - English: Hamadan
City - Persian: همدان
Province: Hamadan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6517838695
Phone: +98 81 3838 0090
Mobile: +98 918 111 3963
Fax:
Email: poorolajal@umsha.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Department of Epidemiology Name of organization / entity - Persian: گروه اپيدميولوژي Full name of responsible person - English: Dr Jalal Poorolajal Full name of responsible person - Persian: دکتر جلال پورالعجل Position - English: Associate Professor Position - Persian: دانشیار Latest degree: phd Area of specialty/work: 02 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشكي همدان، دانشكده بهداشت City - English: Hamadan City - Persian: همدان Province: Hamadan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6517838695 Phone: +98 81 3838 0090 Mobile: 00+98 918 111 3963 Fax: Email: poorolajal@umsha.ac.ir Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
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It depends on the situations and the results of the study as well as approval of the financial supporting organization.
It depends on the situations and the results of the study as well as approval of the financial supporting organization.
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به شرایط و نتایج مطالعه و موافقت سازمان حمایت کننده مالی بستگی دارد.
به شرایط و نتایج مطالعه و موافقت سازمان حمایت کننده مالی بستگی دارد.
Protocol summary
Study aim
To compare the effect of the effect of ketorolac, morphine, and apotel in patients with head trauma
Design
A double blind randomized clinical trial
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
]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
Intervention groups
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.
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
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
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 double-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:
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
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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
Placebo
Not used
Assignment
Parallel
Other design features
.
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
Province
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
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
info.research@umsha.ac.ir
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
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
info.research@umsha.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
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
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
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
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
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
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
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)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available