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IRCT20171003036530N2 IRCT 2018-09-03 Ardabil University of Medical Sciences Comparison the effect of IV Ibuprofen and IV Ketorolac on post operation pain. The comparison of efficacy and side effects of IV( intravenous) Ibuprofen and intravenous Ketorolac in laparoscopic cholecystectomy patients. 2018-05-05 anticipated 90 Complete https://irct.ir/trial/30846 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization method is permuted block randomization in the individual unit. There are 90 sealed envelopes containing three types of code for example there are 30 code numbers for ibuprofen. The person in the operating room will pick an envelope for each patient without knowing the content and the drug will be administered by another person who is not aware of the drug's type, Blinding description: The randomized order of interventions was concealed in opaque individual envelopes by the staff nurse, which were later opened by the nurse in recovery room at the end of surgery. The nurse prescribed drugs(ketorolac, ibuprofen or placebo in equal volume in similar syringes) without knowing patient's ID. The patient's data was collected every six hours without knowing the type of drugs. The principal investigator, patients and outcome assessmentor were blinded to group status, knowing only randomization group codes. 3 cholecystitis. Intervention 1: The first Intervention group will receive a pain pump containing Fentanyl 100 ml and then intravenous Ketorolac 30 mg at intervals of zero, 8 and 16 hours after surgery. Intervention 2: The second Intervention group will receive a pain pump containing Fentanyl and then intravenous Ibuprofen 80 mg at intervals of zero, 8 and 16 hours after surgery. Intervention 3: Control group will receive a pain pump containing fentanyl and then intravenous Placebo at intervals of zero, 8 and 16 hours after surgery. Yes - There is a plan to make this available What will be shared: All data will be published except the patient's ID( individual documents). When: Get started 6 months after printing results To whom: Researchers working in academia or university Conditions: In order to use in any type of scientific research Where to obtain: Email this address:sagarmehrmed@yahoo.com How to obtain: If the applicant send his request, after checking requested information, the data will be sent within a week. Comments:
public Somaye Hoghughi
Daneshgah Ave
Ardebil Iran (Islamic Republic of) 56199-35661 +98 45333582779 sagarmehrmed@yahoo.com Ardabil University of Medical Sciences scientific Dr Ali Mohamadian
Daneshgah Ave
Ardebil Iran (Islamic Republic of) 56199-35661 +98 45 3358 2779 sagarmehrmed@yahoo.com Ardabil University of Medical Sciences Iran (Islamic Republic of) Patients who are undergoing laparoscopic cholecystectomy surgery at Imam Khomeini Hospital in Ardebil. Being at the age of 20 and 60 years old Patients who accept to participate in the research. 20 years 60 years Both Pregnancy History of Asthma and Pulmunary disease History of heart disease History of CKD (chronic kidney disease) or dialysis History of GI (Gastrointestinal) bleeding History of HTN (hypertension) History of Anemia Using Warfarin Consumers simultaneously ACEI (angiotensin converting enzyme inhibitor) and Furosemide Drug dependence Allergic reaction to ibuprofen or NSAIDS or celecoxib k80 cholecystitis Other Other Other The first Intervention group will receive a pain pump containing Fentanyl 100 ml and then intravenous Ketorolac 30 mg at intervals of zero, 8 and 16 hours after surgery. The second Intervention group will receive a pain pump containing Fentanyl and then intravenous Ibuprofen 80 mg at intervals of zero, 8 and 16 hours after surgery. Control group will receive a pain pump containing fentanyl and then intravenous Placebo at intervals of zero, 8 and 16 hours after surgery. Abdominal pain. Timepoint: 6,12 ,18, 24 hours after the operation, pain will be evaluated. Method of measurement: The assessment of abdominal pain is based on the Visual Analogue Scale system. Shoulder pain. Timepoint: 6,12,18,24 hours after surgery. Method of measurement: The assessment of pain is based on the Visual Analogue Scale system. Nausea and Vomiting. Timepoint: 6,12,18,24 hours after surgery. Method of measurement: The assessment is based on the N/V(Nausea and Vomiting)system. Loss of consciousness. Timepoint: 6,12,18,24 hours after surgery. Method of measurement: The assessment is based on the Ramsay score. Ardabil University of Medical Sciences Approved 2017-10-02 Ethics committee of Ardebil University of Medical Sciences Daneshgah Ave Ardebil Ardabil Iran (Islamic Republic of)