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IRCT20161024030479N2 IRCT 2018-06-07 Ardabil University of Medical Sciences Evaluation efficacy and side effects of IV ibuprofen and IV acetaminophen in pain control after laparoscopic cholecystectomy. Evaluation efficacy and side effects of IV ibuprofen and IV acetaminophen in pain control after laparoscopic cholecystectomy 2018-07-23 anticipated 90 Complete https://irct.ir/trial/24207 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sealed envelopes, Blinding description: Prescribing medicine order the drug without information abute patient.Authorities collect data without informing the patient about the drug every six hours .Data evaluator is unaware about the type of drug given to each patient. 3 Cholecystit. Intervention 1: First intervention group(control): for all patients embedded patient-controlled analgesia pump Fentanyl (60 ml in 100cc N/S) throughout the treatment period, patients also had access to Fentanyl (0.5 mg every 15 min) via patient-controlled analgesia or by patient request(PCA). Also receive IV placebo for a total of 3 doses:after the surgery, 8 and 16h after surgery. Intervention 2: Second intervention group: embedded patient-controlled analgesia pump like control group and receive IV acetaminophen 1g for a total of 3 doses:after the surgery, 8 and 16h after surgery. Intervention 3: Third intervention group: embedded patient-controlled analgesia pump like control group and receive IV Ibuprofen 800mg for a total of 3 doses:after the surgery, 8 and 16h after surgery. Yes - There is a plan to make this available What will be shared: all the data will be publish After identifying people.name:Evaluation efficacy and side effects of IV ibuprofen and IV acetaminophen in pain control after laparoscopic cholecystectomy When: it Is accessible 3 months after printing results To whom: Every researcher In all disciplines can receive the information . Conditions: If the data is useful for another study,Available to anyone specializing in this field. Where to obtain: Responsive person is Mahdiyeh masoumzadeh with this way: masoumzadeh.med@gmail.com How to obtain: If the request is submitted to the email address, and the full introduction and explanation of the reason for the request,The data is sent within a week. Comments:
public Ali Mohammadian Erdi
Imam Khomeini Hospital in Ardabil
Ardabil Iran (Islamic Republic of) 56189-85991 +45 33 33 00 64 masoumzadeh.med@gmail.com Ardabil University of Medical Sciences scientific Ali Mohammadian Erdi
Ardabil University of Medical Sciences, Daneshghah st.
Ardabil Iran (Islamic Republic of) 56189-85991 +98 45 3352 2076 a.mohammadian@arums.ac.ir Ardabil University of Medical Sciences Iran (Islamic Republic of) Patients candidate for laparoscopic cholecystectomy Age 20 - 60 years old 20 years 60 years Both 1-Pregnancy Have a history of asthma and other respiratory disease Have a history of heart failure Have a history of CRF or dialysis Have a history of GI bleeding HTN Have a history of Anemia Patients are taking warfarin Patients are taking a combination of ACEI and furosemide Tolerance or dependence to opioids Allergy or hypersensitivity to ibuprofen, ASA, NSAIDs, or COX2 inhibitor Age less than 20 years old and more than 60 years old K80 Cholecystit Placebo Treatment - Drugs Treatment - Drugs First intervention group(control): for all patients embedded patient-controlled analgesia pump Fentanyl (60 ml in 100cc N/S) throughout the treatment period, patients also had access to Fentanyl (0.5 mg every 15 min) via patient-controlled analgesia or by patient request(PCA). Also receive IV placebo for a total of 3 doses:after the surgery, 8 and 16h after surgery. Second intervention group: embedded patient-controlled analgesia pump like control group and receive IV acetaminophen 1g for a total of 3 doses:after the surgery, 8 and 16h after surgery. Third intervention group: embedded patient-controlled analgesia pump like control group and receive IV Ibuprofen 800mg for a total of 3 doses:after the surgery, 8 and 16h after surgery. Severity of pain in the surgical site. Timepoint: 6, 12, 18 and 24 hours after surgery. Method of measurement: VAS system. Nausea and vomiting. Timepoint: 6,12,18 and 24 hours after surgery. Method of measurement: N/V Score. Shoulder pain. Timepoint: 6,12,18 and 24 hours after surgery. Method of measurement: VAS. Sedation. Timepoint: 6,12,18 and 24 hours after surgery. Method of measurement: Ramsay score. Ardabil University of Medical Sciences Approved 2017-01-29 Ardabil University of Medical Sciences Ardabil University of Medical Sciences, Daneshgah st. Ardabil Ardabil Iran (Islamic Republic of)