Comparison of the effect of Acetaminophen, Pethidine and Ibuprofen on pain relief in patients with acute cholecystitis: a triple blind randomized clinical trial
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Protocol summary
Objectives: To compare the effect of Acetaminophen, Pethidine and Ibuprofen on pain relief in patients with acute cholecystitis.
Design: A triple blind randomized clinical trial.
Setting and conduct: The eligible patients with acute cholecystitis who will refer to Besat Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 55 years; acute cholecystitis.
Exclusion criteria: Pregnancy; using analgesic within pass 6 hours; addiction to narcotic or psychedelic; contraindication of Acetaminophen, Pethidine, or Ibuprofen; chronic renal failure.
Intervention group 1: Intravenous infusion of 10 mg/kg Acetaminophen in 100 ml normal saline within 30 minutes single dose.
Intervention group 2: Intravenous infusion of 10 mg/kg Ibuprofen in 100 ml normal saline within 30 minutes single dose.
Intervention group 3: Intravenous infusion of 1 mg/kg Pethidine in 100 ml normal saline within 30 minutes single dose.
Primary outcome: Measuring severity of pain before infusion and 30, 60, and 90 minutes after infusion using Visual Analog Scale (VAS).
Secondary outcome: Assessing nausea and vomiting before infusion and 30, 60, and 90 minutes after infusion by taking history.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
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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Objectives: To compare the effect of Acetaminophen, Pethidine and Ibuprofen on pain relief in patients with acute cholecystitis. Design: A triple blind randomized clinical trial. Setting and conduct: The eligible patients with acute cholecystitis who will refer to Besat Hospital during the study period will be enrolled into the trial. Inclusion criteria: Age of 18 to 55 years; acute cholecystitis. Exclusion criteria: Pregnancy; using analgesic within pass 6 hours; addiction to narcotic or psychedelic; contraindication of Acetaminophen, Pethidine, or Ibuprofen; chronic renal failure. Intervention group 1: Intravenous infusion of 10 mg/kg Acetaminophen in 100 ml normal saline within 30 minutes single dose. Intervention group 2: Intravenous infusion of 10 mg/kg Ibuprofen in 100 ml normal saline within 30 minutes single dose. Intervention group 3: Intravenous infusion of 1 mg/kg Pethidine in 100 ml normal saline within 30 minutes single dose. Primary outcome: Measuring severity of pain before infusion and 30, 60, and 90 minutes after infusion using Visual Analog Scale (VAS). Secondary outcome: Assessing nausea and vomiting before infusion and 30, 60, and 90 minutes after infusion by taking history. Randomization: The patients will be randomly assigned to intervention and control groups using block randomization. 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.
اهداف: تعيين اثر استامینوفن، پتدین و ایبوپروفن بر کاهش درد بیماران مبتلا به کوله سیستیت حاد.
طراحی: کارآزمایی بالینی تصادفی شده سه سو کور.
نحوه انجام: بیماران مبتلا به کوله سیستیت حاد که در طول مطالعه به بیمارستان بعث مراجعه نمایند در صورت واجد شرایط بودن وارد مطالعه خواهند شد.
شرایط ورود: سن 18 تا 55 سال؛ کوله سیستیت حاد.
شرایط خروج: حاملگی؛ مصرف داروی مسکن طی 6 ساعت گذشته؛ اعتیاد به مواد مخدر یا روانگردان؛ ممنوعیت مصرف استامینوفن، ایبوپروفن یا پتدین؛ نارسایی مزمن کلیوی.
گروه مداخله 1: انفوزیون وریدی 10 میلی گرم بر کیلوگرم استامینوفن تزریقی در 100 میلی لیتر نرمال سالین در مدت 30 دقیقه یکبار.
گروه مداخله 2: انفوزیون وریدی 10 میلی گرم بر کیلوگرم ایبوپروفن تزریقی در 100 میلی لیتر نرمال سالین در مدت 30 دقیقه یکبار.
گروه مداخله 3: انفوزیون وریدی 1 میلی گرم بر کیلوگرم پتدین تزریقی در 100 میلی لیتر نرمال سالین در مدت 30 دقیقه یکبار.
پیامد اولیه: اندازه گیری شدت درد قبل از تزریق و 30، 60 و 90 پس از تزریق با استفاده از مقیاس دیداری درد (VAS).
پیامد ثانویه: بررسی تهوع و استفراغ قبل از تزریق و 30، 60 و 90 پس از تزریق با گرفتن شرح حال.
روش تصادفی سازی: تخصیص تصادفی بیماران به گروه مداخله و کنترل به روش بلوك هاي تصادفي.
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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اهداف: تعيين اثر استامینوفن، پتدین و ایبوپروفن بر کاهش درد بیماران مبتلا به کوله سیستیت حاد. طراحی: کارآزمایی بالینی تصادفی شده سه سو کور. نحوه انجام: بیماران مبتلا به کوله سیستیت حاد که در طول مطالعه به بیمارستان بعث مراجعه نمایند در صورت واجد شرایط بودن وارد مطالعه خواهند شد. شرایط ورود: سن 18 تا 55 سال؛ کوله سیستیت حاد. شرایط خروج: حاملگی؛ مصرف داروی مسکن طی 6 ساعت گذشته؛ اعتیاد به مواد مخدر یا روانگردان؛ ممنوعیت مصرف استامینوفن، ایبوپروفن یا پتدین؛ نارسایی مزمن کلیوی. گروه مداخله 1: انفوزیون وریدی 10 میلی گرم بر کیلوگرم استامینوفن تزریقی در 100 میلی لیتر نرمال سالین در مدت 30 دقیقه یکبار. گروه مداخله 2: انفوزیون وریدی 10 میلی گرم بر کیلوگرم ایبوپروفن تزریقی در 100 میلی لیتر نرمال سالین در مدت 30 دقیقه یکبار. گروه مداخله 3: انفوزیون وریدی 1 میلی گرم بر کیلوگرم پتدین تزریقی در 100 میلی لیتر نرمال سالین در مدت 30 دقیقه یکبار. پیامد اولیه: اندازه گیری شدت درد قبل از تزریق و 30، 60 و 90 پس از تزریق با استفاده از مقیاس دیداری درد (VAS). پیامد ثانویه: بررسی تهوع و استفراغ قبل از تزریق و 30، 60 و 90 پس از تزریق با گرفتن شرح حال. روش تصادفی سازی: تخصیص تصادفی بیماران به گروه مداخله و کنترل به روش بلوك هاي تصادفي. 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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To compare the effect of Acetaminophen, Pethidine and Ibuprofen on pain relief in patients with acute cholecystitis.
To compare the effect of Acetaminophen, Pethidine and Ibuprofen on pain relief in patients with acute cholecystitis.
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تعيين اثر استامینوفن، پتدین و ایبوپروفن بر کاهش درد بیماران مبتلا به کوله سیستیت حاد
تعيين اثر استامینوفن، پتدین و ایبوپروفن بر کاهش درد بیماران مبتلا به کوله سیستیت حاد
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A triple blind randomized clinical trial.
A triple blind randomized clinical trial.
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کارآزمایی بالینی تصادفی شده سه سو کور
کارآزمایی بالینی تصادفی شده سه سو کور
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The eligible patients with acute cholecystitis who will refer to Besat Hospital during the study period will be enrolled into the trial.
The eligible patients with acute cholecystitis who will refer to Besat Hospital during the study period will be enrolled into the trial.
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بیماران مبتلا به کوله سیستیت حاد که در طول مطالعه به بیمارستان بعث مراجعه نمایند در صورت واجد شرایط بودن وارد مطالعه خواهند شد
بیماران مبتلا به کوله سیستیت حاد که در طول مطالعه به بیمارستان بعث مراجعه نمایند در صورت واجد شرایط بودن وارد مطالعه خواهند شد
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Inclusion criteria: Age of 18 to 75 years; acute cholecystitis.
Exclusion criteria: Pregnancy; using analgesic within pass 6 hours; addiction to narcotic or psychedelic; contraindication of Acetaminophen, Pethidine, or Ibuprofen; chronic renal failure.
Inclusion criteria: Age of 18 to 75 years; acute cholecystitis. Exclusion criteria: Pregnancy; using analgesic within pass 6 hours; addiction to narcotic or psychedelic; contraindication of Acetaminophen, Pethidine, or Ibuprofen; chronic renal failure.
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شرایط ورود: سن 18 تا 75 سال؛ کوله سیستیت حاد.
شرایط خروج: حاملگی؛ مصرف داروی مسکن طی 6 ساعت گذشته؛ اعتیاد به مواد مخدر یا روانگردان؛ ممنوعیت مصرف استامینوفن، ایبوپروفن یا پتدین؛ نارسایی مزمن کلیوی.
شرایط ورود: سن 18 تا 75 سال؛ کوله سیستیت حاد. شرایط خروج: حاملگی؛ مصرف داروی مسکن طی 6 ساعت گذشته؛ اعتیاد به مواد مخدر یا روانگردان؛ ممنوعیت مصرف استامینوفن، ایبوپروفن یا پتدین؛ نارسایی مزمن کلیوی.
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Intervention group 1: Intravenous infusion of 10 mg/kg Acetaminophen in 100 ml normal saline within 30 minutes single dose.
Intervention group 2: Intravenous infusion of 10 mg/kg Ibuprofen in 100 ml normal saline within 30 minutes single dose.
Intervention group 3: Intravenous infusion of 1 mg/kg Pethidine in 100 ml normal saline within 30 minutes single dose.
Intervention group 1: Intravenous infusion of 10 mg/kg Acetaminophen in 100 ml normal saline within 30 minutes single dose. Intervention group 2: Intravenous infusion of 10 mg/kg Ibuprofen in 100 ml normal saline within 30 minutes single dose. Intervention group 3: Intravenous infusion of 1 mg/kg Pethidine in 100 ml normal saline within 30 minutes single dose.
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گروه مداخله 1: انفوزیون وریدی 10 میلی گرم بر کیلوگرم استامینوفن تزریقی در 100 میلی لیتر نرمال سالین در مدت 30 دقیقه یکبار.
گروه مداخله 2: انفوزیون وریدی 10 میلی گرم بر کیلوگرم ایبوپروفن تزریقی در 100 میلی لیتر نرمال سالین در مدت 30 دقیقه یکبار.
گروه مداخله 3: انفوزیون وریدی 1 میلی گرم بر کیلوگرم پتدین تزریقی در 100 میلی لیتر نرمال سالین در مدت 30 دقیقه یکبار.
گروه مداخله 1: انفوزیون وریدی 10 میلی گرم بر کیلوگرم استامینوفن تزریقی در 100 میلی لیتر نرمال سالین در مدت 30 دقیقه یکبار. گروه مداخله 2: انفوزیون وریدی 10 میلی گرم بر کیلوگرم ایبوپروفن تزریقی در 100 میلی لیتر نرمال سالین در مدت 30 دقیقه یکبار. گروه مداخله 3: انفوزیون وریدی 1 میلی گرم بر کیلوگرم پتدین تزریقی در 100 میلی لیتر نرمال سالین در مدت 30 دقیقه یکبار.
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Primary outcome: Measuring the severity of pain
Secondary outcome: Assessing nausea and vomiting
Primary outcome: Measuring the severity of pain Secondary outcome: Assessing nausea and vomiting
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پیامد اولیه: اندازه گیری شدت درد
پیامد ثانویه: بررسی تهوع و استفراغ
پیامد اولیه: اندازه گیری شدت درد پیامد ثانویه: بررسی تهوع و استفراغ
General information
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Age of 18 to 75 years;
Acute cholecystitis
Age of 18 to 75 years; Acute cholecystitis
سن 18 تا 75 سال؛
کوله سیستیت حاد
سن 18 تا 75 سال؛ کوله سیستیت حاد
Pregnancy;
using analgesic within pass 6 hours;
Addiction to narcotic or psychedelic;
Contraindication of Acetaminophen, Pethidine, or Ibuprofen;
Chronic renal failure
Pregnancy; using analgesic within pass 6 hours; Addiction to narcotic or psychedelic; Contraindication of Acetaminophen, Pethidine, or Ibuprofen; Chronic renal failure
حاملگی؛
مصرف داروی مسکن طی 6 ساعت گذشته؛
اعتیاد به مواد مخدر یا روانگردان؛
ممنوعیت مصرف استامینوفن، ایبوپروفن یا پتدین؛
نارسایی مزمن کلیوی
حاملگی؛ مصرف داروی مسکن طی 6 ساعت گذشته؛ اعتیاد به مواد مخدر یا روانگردان؛ ممنوعیت مصرف استامینوفن، ایبوپروفن یا پتدین؛ نارسایی مزمن کلیوی
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The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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بیماران به صورت تصادفی به گروه مداخله و کنترل به روش بلوك هاي تصادفي تخصیص داده می شوند. برای این منظور بلوکهای چهارتایی تهیه می شود که روی دو برگه نام مداخله و روی دو برگه دیگر نام مقایسه نوشته می شود. برگه ها روی هم ریخته شده و در ظرف قرار داده می شود و برای هر بیمار یک برگه بدون جایگذاری بیرون کشیده می شود. سپس چهار برگه به ظرف برگردانده می شود و این عمل تا رسیدن به حجم نمونه تکرار می شود.
بیماران به صورت تصادفی به گروه مداخله و کنترل به روش بلوك هاي تصادفي تخصیص داده می شوند. برای این منظور بلوکهای چهارتایی تهیه می شود که روی دو برگه نام مداخله و روی دو برگه دیگر نام مقایسه نوشته می شود. برگه ها روی هم ریخته شده و در ظرف قرار داده می شود و برای هر بیمار یک برگه بدون جایگذاری بیرون کشیده می شود. سپس چهار برگه به ظرف برگردانده می شود و این عمل تا رسیدن به حجم نمونه تکرار می شود.
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The shape of the medications will be perfectly 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. The analyzer will be unaware of the type of interventions Therefore, the trial will be run as triple blind
The shape of the medications will be perfectly 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. The analyzer will be unaware of the type of interventions Therefore, the trial will be run as triple blind
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شکل داروها کاملاً یکسان است بنابراین 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
شکل داروها کاملاً یکسان است بنابراین 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
Recruitment centers
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Name of recruitment center - English: Besat Hospital
Name of recruitment center - Persian: بیمارستان بعثت
Full name of responsible person - English: Dr Mohammad Jafari Azandaryani
Full name of responsible person - Persian: دکتر محمد جعفری ازندریانی
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 Mohammad Jafari Azandaryani
Full name of responsible person - Persian: دکتر محمد جعفری ازندریانی
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: 9183511324
Phone: +98 81 3364 0030
Fax:
Email: sharifi333@yahoo.com
Web page address:
Name of recruitment center - English: Besat Hospital Name of recruitment center - Persian: بیمارستان بعثت Full name of responsible person - English: Dr Mohammad Jafari Azandaryani Full name of responsible person - Persian: دکتر محمد جعفری ازندریانی 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: 9183511324 Phone: +98 81 3364 0030 Fax: Email: sharifi333@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice-chancellor for Research and 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 and 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: 33640030
Phone: +98 81 3838 0717
Fax:
Email: v.c_research@umsha.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice-chancellor for Research and 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: 33640030 Phone: +98 81 3838 0717 Fax: Email: v.c_research@umsha.ac.ir Web page address:
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Domestic
domestic
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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 Rasool Salimi
Full name of responsible person - Persian: دکتر رسول سلیمی
Position - English: Specialist of Emergency Medicine
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: +98 918 351 0164
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 Rasool Salimi
Full name of responsible person - Persian: دکتر رسول سلیمی
Position - English: Specialist of Emergency Medicine
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: +98 918 351 0164
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 Rasool Salimi Full name of responsible person - Persian: دکتر رسول سلیمی Position - English: Specialist of Emergency Medicine 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: +98 918 351 0164 Fax: Email: rasoulsl@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 Rasool Salimi
Full name of responsible person - Persian: دکتر رسول سلیمی
Position - English: Specialist of Emergency Medicine
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: +91 83510164
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 Rasool Salimi
Full name of responsible person - Persian: دکتر رسول سلیمی
Position - English: Specialist of Emergency Medicine
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: +98 918 351 0164
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 Rasool Salimi Full name of responsible person - Persian: دکتر رسول سلیمی Position - English: Specialist of Emergency Medicine 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: +91 8351016498 918 351 0164 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:
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
empty
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.
empty
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 Acetaminophen, Pethidine and Ibuprofen on pain relief in patients with acute cholecystitis.
Design
A triple blind randomized clinical trial.
Settings and conduct
The eligible patients with acute cholecystitis who will refer to Besat Hospital during the study period will be enrolled into the trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 75 years; acute cholecystitis.
Exclusion criteria: Pregnancy; using analgesic within pass 6 hours; addiction to narcotic or psychedelic; contraindication of Acetaminophen, Pethidine, or Ibuprofen; chronic renal failure.
Intervention groups
Intervention group 1: Intravenous infusion of 10 mg/kg Acetaminophen in 100 ml normal saline within 30 minutes single dose.
Intervention group 2: Intravenous infusion of 10 mg/kg Ibuprofen in 100 ml normal saline within 30 minutes single dose.
Intervention group 3: Intravenous infusion of 1 mg/kg Pethidine in 100 ml normal saline within 30 minutes single dose.
Main outcome variables
Primary outcome: Measuring the severity of pain
Secondary outcome: Assessing nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201710059014N191
Registration date:2017-10-05, 1396/07/13
Registration timing:prospective
Last update:2019-03-07, 1397/12/16
Update count:1
Registration date
2017-10-05, 1396/07/13
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 and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Acetaminophen, Pethidine and Ibuprofen on pain relief in patients with acute cholecystitis: a triple blind randomized clinical trial
Public title
Comparison of the effect of Acetaminophen, Pethidine and Ibuprofen on pain relief in patients with acute cholecystitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 75 years;
Acute cholecystitis
Exclusion criteria:
Pregnancy;
using analgesic within pass 6 hours;
Addiction to narcotic or psychedelic;
Contraindication of Acetaminophen, Pethidine, or Ibuprofen;
Chronic renal failure
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The shape of the medications will be perfectly 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. The analyzer will be unaware of the type of interventions Therefore, the trial will be run as triple blind
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
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
Province
Hamadan
Postal code
9183511324
Approval date
2017-09-02, 1396/06/11
Ethics committee reference number
IR.UMSHA.REC.1396.409
Health conditions studied
1
Description of health condition studied
Acute cholecystitis
ICD-10 code
K81.0
ICD-10 code description
Acute cholecystitis
Primary outcomes
1
Description
Measuring severity of pain
Timepoint
before infusion and 30, 60, and 90 minutes after infusion
Method of measurement
using Visual Analog Scale (VAS)
Secondary outcomes
1
Description
Assessing nausea and vomiting
Timepoint
before infusion and 30, 60, and 90 minutes after infusion
Method of measurement
by taking history
Intervention groups
1
Description
Intervention group 1: Intravenous infusion of 10 mg/kg Acetaminophen in 100 ml normal saline within 30 minutes single dose.
Category
Treatment - Drugs
2
Description
Intervention group 2: Intravenous infusion of 10 mg/kg Ibuprofen in 100 ml normal saline within 30 minutes single dose.
Category
Treatment - Drugs
3
Description
Intervention group 3: Intravenous infusion of 1 mg/kg Pethidine in 100 ml normal saline within 30 minutes single dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Mohammad Jafari Azandaryani
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
9183511324
Phone
+98 81 3364 0030
Email
sharifi333@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and 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
33640030
Phone
+98 81 3838 0717
Email
v.c_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 and 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 Rasool Salimi
Position
Specialist 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
rasoulsl@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Dr Rasool Salimi
Position
Specialist 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
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