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临床试验/IRCT138711051323N2
IRCT138711051323N2已完成3 期

Comparison of efficacy and complications of Fentanyl and combination of Midazolam and Pethedine for pain control in ESW

Research manager of Yasuj University of Medical Sciences0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
100

研究概览

简要总结

Comparison of fentanyl and combination of pethedine and midazolam for pain control during extracorporeal shock wave lithotripsy
Mehrabi S (MD)1, Karimzadeh-Shirazi K (PhD)2, Hadinia A (MSc)3
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.
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).
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.
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).
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.
Keywords: Fentanyl, ESWL, Midazolam, Pethedin, Pain.
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研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 no limit(—)
性别
All

入选标准

  • 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

排除标准

  • 未提供

研究者

发起方
Research manager of Yasuj University of Medical Sciences

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