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IRCT201105166504N1 IRCT 2011-08-08 Tehran University of Medical Sciences-Vice Chancellor for Research Opioid sparing effects of intra-venous paracetamol after Percutaneous Nephrolithotomy: a randomized double blinded controlled trail Opioid sparing effects of intra-venous paracetamol after Percutaneous Nephrolithotomy: a randomized double blinded controlled trail 2011-06-14 anticipated 100 Complete https://irct.ir/trial/6964 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 PCNL. Intervention 1: Enrolled patients will be randomly allocated to 100 placebo and paracetamol groups using balance blocked randomization method (50 patients in each group). In paracetamol group, each patient will receive 100cc normal saline and 1gr paracetamol intravenously 30 minutes after extubation and then every 8 hours until 24 hours. Intervention 2: In control group: In the control group they will received 100cc of normal saline 30 minutes after extubation and every 8 hours for 24 hours (4 times overall).
public Meghdad Tabatabaie
Valinejad Ave, Vanak Sq, Valiasr St
Tehran Iran (Islamic Republic of) +98 21 8864 4486 meghdad58@yahoo.co.uk Tehran University of Medical Scince scientific Robab Maghsoudi
Valinejhad Ave, Vanak Sq, Valiasr Sr
Tehran Iran (Islamic Republic of) +98 21 8864 4486 rmaghsudy@yahoo.com Tehran University Of Medical Scince Iran (Islamic Republic of) Inclusion criteria: Renal calculi candidate for PCNL; Age between 18 -70 years old; American Society of Anesthesiologists (ASA) risk class I (normal healthy patient)). Exclusion criteria: Pregnancy and lactation; Drug and alcohol abuse; Previous history of any allergy to acetaminophen and opioid; Previous history of hepatic (transaminase exciding two times and more of normal limits) or renal failure (serum creatinine exciding 1.5 mg/dl); Bleeding tendency; Consumption of mono-amino-oxidase inhibitors (MAO inhibitors) or their discontinue over past 2 weeks; Other painful physical conditions which might confound pain assessment; Psychiatric or medical conditions that might impair communication or compliance with the study procedures; Use of NSAIDs or other analgesic drug within 12 h preceding study medications; Age below 18 and above 70 years old 18 years 70 years Both N20.0 Calculus of kidney Treatment - Drugs Treatment - Drugs Enrolled patients will be randomly allocated to 100 placebo and paracetamol groups using balance blocked randomization method (50 patients in each group). In paracetamol group, each patient will receive 100cc normal saline and 1gr paracetamol intravenously 30 minutes after extubation and then every 8 hours until 24 hours. In control group: In the control group they will received 100cc of normal saline 30 minutes after extubation and every 8 hours for 24 hours (4 times overall). Pain score. Timepoint: every 4 hours. Method of measurement: VAS. Paracetamol dose. Timepoint: every 8 hours. Method of measurement: patient records. Pethidine dose. Timepoint: After PCNL surgery. Method of measurement: Patients' records. Tehran University of Medical Sciences-Vice Chancellor for Research Approved 2011-05-22 Tehran university of medical science, Ethics committee Tehran University of Medical Scince, Hemat high way, Pardise Hemat. Tehran Iran (Islamic Republic of)