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IRCT2013092612695N1 IRCT 2013-10-14 Deputy of Research,Tehran University of Medical Sciences Comparison of painless effects between ketamin and combination of ketamin and bupivacaine in patient with renal calculi Comparison of painless effects between ketamin and combinations of different doses of ketamin and bupivacaine after Percutaneous Nephrolithotripsi (PCNL) in patients with renal calculi. 2012-03-20 anticipated 50 Complete https://irct.ir/trial/12718 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This was a double-blind, 5-arm, parallel-group, placebo-controlled, randomized study. Four groups were consider the experimental treatment under study, while the one group was consider as a control group and was given a placebo. According to a table of random number, the patients were randomized to 1 of the following 5 treatment regimens. In this study, two groups of individuals involved in the trial did not know the identity of the intervention that is given to each participant. These two groups included the participants and the investigators in charge of assessing the outcomes of the interventions. 3 Nephrolithiasis. Intervention 1: 1th Intervention:2 cc of bupivacaine 0.5%, 6 ml of distilled water. Intervention 2: 2th Intervention: 2 cc of bupivacaine 0.5%, 5 ml of distilled water and 1cc of ketamine 5%. Intervention 3: 3th Intervention: 2 cc of bupivacaine 0.5%, 5 ml of distilled water and 1cc of ketamine 5%. Intervention 4: 4th Intervention: ketamine 5%, 1mg/kg. Intervention 5: Control: 2 cc of normal saline.
public Mohammad Reza Khajavi
Imam khomeni St, Hasan Abad Sq, Sina hospital
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 0000 KHAGAVIM@TUMS.AC.IR Sina Hospital, Tehran University of Medical Sciences scientific Mohammad Reza Khajavi
Imam khomeni St, Hasan Abad Sq, Sina hospital
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 0000 khajavim@tums.ac.ir Sina Hospital, Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1- 18-75 years. 2- Presence of calculi only in kidney itself. Exclusion criteria: 1- Drug abuser 2- Pregnancy 3- History of renal disease 4- Serum creatinine level more than 2mg/dl 5- History of uncontrolled Hypertension 6- History of psychological disorders and use of psychoactive drug 18 years 75 years Both N20.0 Nephrolithiasis NOS Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo 1th Intervention:2 cc of bupivacaine 0.5%, 6 ml of distilled water 2th Intervention: 2 cc of bupivacaine 0.5%, 5 ml of distilled water and 1cc of ketamine 5% 3th Intervention: 2 cc of bupivacaine 0.5%, 5 ml of distilled water and 1cc of ketamine 5% 4th Intervention: ketamine 5%, 1mg/kg Control: 2 cc of normal saline Pain. Timepoint: 5-10-15-30 min after extubation, recovery, 1-6-12-24 hours after the patient has been transferred to the ward. Method of measurement: Visual Analogue Scale. Opioid consumption. Timepoint: Recovery and 24 hour after surgery. Method of measurement: mg. Agitation. Timepoint: 5-10-15-30 min after extubation, recovery, 1-6-12-24 hours after ward admission. Method of measurement: Richmond Agitation Sedation Scale. Deputy of Research,Tehran University of Medical Sciences Approved 2013-04-21 Ethics committee of Tehran University of Medical Sciences Central building of Tehran University of Medical sciences, Ghods st, Keshavarz blv. Tehran Iran (Islamic Republic of)