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IRCT138711051323N2 IRCT 2010-05-29 Research manager of Yasuj University of Medical Sciences Comparison of efficacy and complications of Fentanyl and combination of Midazolam and Pethedine for pain control in ESWL Comparison of efficacy and complications of Fentanyl and combination of Midazolam and Pethedine for pain control in ESWL 2008-08-20 anticipated 100 Complete https://irct.ir/trial/571 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Calculus of kidney and ureter. Intervention 1: intravenous injection of 50 mligrams Pethedin and 1 miligram Midazolam, 5 minutes before ESWL. Intervention 2: intravenous injection of 50 microgram of Fentanyl 5 minutes before ESWL. Comparison of fentanyl and combination of pethedine and midazolam for pain control during extracorporeal shock wave lithotripsy<br /> Mehrabi S (MD)1, Karimzadeh-Shirazi K (PhD)2, Hadinia A (MSc)3<br /> 1Urology Dept., Yasuj University of Medical Sciences Yasuj, Iran, 2Health Education Dept., Yasuj University of Medical Sciences, Yasuj, Iran, 3Immunology Dept., Yasuj University of Medical Sciences, Yasuj, Iran.<br /> Background and aim: Shock wave during extracorporeal lithotripsy causes pain for which analgesic drugs are prescribed most often. The aim of this study was to compare the efficacy and adverse effects of fentanyl and combination of pethedine and midazolam for pain control during extracorporeal shockwave lithotripsy (ESWL).<br /> Methods: In this single blind clinical trial study, 89 patients older than 18 years with renal or upper urethral stones who were candidates for ESWL were randomly allocated into Intervention (45 patients) and control groups (44 patients). First group (Intervention) was given I.V. fentanyl (1 mg/kg) and control group was given I.V. pethedine (0.7 mg/kg) and (0.02 mg/kg) midazolam before starting ESWL. Then ESWL was performed in two groups with guidance of fluoroscopy by standard technique. During operation every 20 minutes and 2 hours after operation severity of pain was checked according to visual analogue scale. Efficacy of operation was evaluated in two groups according to follow up KUB and ultrasonography. Data were analyzed by SPSS software using Chi square test.<br /> Results: Frequency of painless operation and mild pain in fentanyl group were found 26.6 and 24.4 percents, respectively. Although severe pain was more observed in the control group (32.5%), but it was not significantly different (P>0.05). Efficacy of operation didn’t show significant difference between two groups of patients (P>0.05).<br /> Conclusion: Similar pethedine and midazolam lower dose of intravenous fentanyl provides adequate analgesia with minimal side effects and suitable efficacy for pain control during ESWL, which can be used in outpatients, without need to monitoring in adult patients.<br /> Keywords: Fentanyl, ESWL, Midazolam, Pethedin, Pain.<br /> Cite
public Dr Sadrollah Mehrabi
Yasuj University of Medical Sciences, Motahari street, Yasuj
Yasuj Iran (Islamic Republic of) 7591741417 +98 74 1222 6517 mehrabi390@yahoo.com and dr mehrabiyums.ac.ir Urology Department, Yasuj University of Medical Sciences scientific Dr Sadrollah Mehrabi
Yasuj University of Medical Sciences, Motahari street, Yasuj
Yasuj Iran (Islamic Republic of) 7591741417 +98 74 1222 6517 mehrabi390@yahoo.com and dr mehrabiyums.ac.ir Urology Department, Yasuj University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Age more than 18 years, renal or upper ureteral stone, stone size between 6-25 mm Exclusion criteria: Presence of Coagulopathy, presence of neuropathy, stone size more than 25mm in kidney and more than 15mm in ureter, presence of active infection, presence of azotemia, uncontrolled hypertension, hypersensitivity to narcotic drugs, pregnancy 18 years no limit Both N20.2 Calculus of kidney and ureter Treatment - Drugs Treatment - Drugs intravenous injection of 50 mligrams Pethedin and 1 miligram Midazolam, 5 minutes before ESWL intravenous injection of 50 microgram of Fentanyl 5 minutes before ESWL Pain. Timepoint: Before procedure and every 20 minutes during operation and one hour later. Method of measurement: Visual analoge scale. Clerance of kidney or ureter from the stone. Timepoint: 2 weeks later. Method of measurement: ultrasonography and KUB. Pulmunary or cardiovascular complications. Timepoint: Before procedure and every 20 minutes during the operation and one hour later. Method of measurement: Checking blood pressure every 20 minutes and Pulseoximetey during the procedure. Research manager of Yasuj University of Medical Sciences Approved Ethics committee Yasuj University of Medical Sciences Yasuj university of Medical Sciences, Motahari street, Yasuj, Iran Yasuj Iran (Islamic Republic of)