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IRCT20141116019971N4 IRCT 2019-09-02 Tehran University of Medical Sciences Propofol plus paracetamol in benign headaches. Evaluating the effectiveness of intravenous Propofol plus paracetamol versus paracetamol alone in benign headaches, a randomized placebo controlled clinical trial. 2019-08-19 anticipated 80 Complete https://irct.ir/trial/41483 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Computer-generated block randomization, Blinding description: A pharmacist was providing the medication and placebo in the masked vials. Physicians were not aware of the patient's assignment. The nurse who was injecting the drug was also unaware of patients assignment. 2-3 Headache. Intervention 1: Intervention group: receives 1gr of intravenous paracetamol in 100 ccs normal saline over 20 minutes and 1mg/kg intravenous propofol. Medications: 1. Paracetamol: G.E.S. Injection 10 mg/ml,100 ml, Genpharma Co (Spain) 2. Propofol: LIPURO Injection 10mg/ml,50 ml, B.Braun (Germany) 3. Normal saline: SODIUM CHLORIDE 0.9% INF P-BOTTLE, SAMEN Co, 1L. Intervention 2: Control group: receives 1gr of intravenous paracetamol in 100 ccs normal saline over 20 minutes and placebo. Medications: 1. Paracetamol: G.E.S. Injection 10 mg/ml,100 ml, Genpharma Co (Spain) 2. Normal saline: SODIUM CHLORIDE 0.9% INF P-BOTTLE, SAMEN Co, 1L 3. Placebo: Normal saline will be used as a placebo. Yes - There is a plan to make this available What will be shared: upon completion of the study, Individual participant data (anonymous) comprising age, gender, pain intensity, and vital signs will be released. When: Access to the information starts in 2020. To whom: All researchers have the possibility to access the data regardless of the research field. Conditions: There are no specific criteria for data access. Where to obtain: To request data access, please contact to Dr Ehsan Karimi. E-mail: drkarimi86@gmail.com, Phone number: 00989122493628, Address: Dr Shariati hospital,North Karegar ave, . How to obtain: Upon contact, data will be sent by email. Comments:
public Mojtaba Aghili
Dr gharib Avenue, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6690 4848 aghili220@yahoo.com Tehran University of Medical Sciences scientific Ehsan Karimialavijeh
Dr Shariati hospital, North Karegar Ave
Tehran Iran (Islamic Republic of) 1411713135 +98 21 84901 drkarimi86@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18 years and above Benign headaches 18 years no limit Both Suspicious to secondary headaches based on the attending physician's judgment Abnormal vital signs Variation in the level of consciousness Fever Focal neurologic defficite Pregnancy Allergy to the egg yolk, acetaminophen or propofol Neck stiffness Hepatic failure an chronic liver disease R51 Headache Treatment - Drugs Placebo Intervention group: receives 1gr of intravenous paracetamol in 100 ccs normal saline over 20 minutes and 1mg/kg intravenous propofol. Medications: 1. Paracetamol: G.E.S. Injection 10 mg/ml,100 ml, Genpharma Co (Spain) 2. Propofol: LIPURO Injection 10mg/ml,50 ml, B.Braun (Germany) 3. Normal saline: SODIUM CHLORIDE 0.9% INF P-BOTTLE, SAMEN Co, 1L Control group: receives 1gr of intravenous paracetamol in 100 ccs normal saline over 20 minutes and placebo. Medications: 1. Paracetamol: G.E.S. Injection 10 mg/ml,100 ml, Genpharma Co (Spain) 2. Normal saline: SODIUM CHLORIDE 0.9% INF P-BOTTLE, SAMEN Co, 1L 3. Placebo: Normal saline will be used as a placebo. Pain intensity. Timepoint: 0,10, 20, 30, 60 minutes. Method of measurement: Numeric rating scale. Blood pressure. Timepoint: 0,10, 20, 30, 60 minutes. Method of measurement: Blood pressure cuff. Heart rate. Timepoint: 0,10, 20, 30, 60 minutes. Method of measurement: Cardiac monitoring device. Oxygen saturation. Timepoint: 0,10, 20, 30, 60 minutes. Method of measurement: Puls oxymeter. Tehran University of Medical Sciences Approved 2015-04-07 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Poorsina Avenue, Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)