Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
64 participants
INTERVENTIONAL
2008-10-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group Control (n=32):iv 1.5 ml/kg 0.9% NaCl
Placebo
Group Paracetamol(n=32):iv 15mg/kg paracetamol
The patients were randomly divided into two groups: Group P (Paracetamol group, n=32) received intravenous 15mg/kg paracetamol during the surgery and Group C (Control Group, n=32) received intravenous 1.5 ml/kg 0.9% NaCl solution 30 minutes before the of surgery.At the end of the surgery, all patients had an nephrostomy catheter and the insertion site was infiltrated with 20 ml 0.25% bupivacaine infiltration for postoperative analgesia. Each patient received patient-controlled intravenous analgesia by meperidine (10 mg bolus, 20-minute lock-out, no infusion dose and 4 hour limit) for postoperative analgesia. All patients were planned to receive tenoxicam 20 mg intravenously as a rescue analgesic when visual analogue scale (VAS) was \>3.
intravenous paracetamol
Interventions
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intravenous paracetamol
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) Physical Status of I-II,
* undergoing PNL with urinary bladder catheter.
Exclusion Criteria
* chronic opioid use,
* bladder outflow obstruction,
* benign prostatic hyperplasia, and
* overactive bladder (OAB) (frequency \> 3 times at night or \> 8 times within 24h).
18 Years
65 Years
ALL
No
Sponsors
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Pinar Ergenoglu
OTHER
Responsible Party
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Pinar Ergenoglu
Baskent University School of Medicine Adana Teaching and Research Hospital
Locations
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Baskent University School of Medicine Adana Teaching and Research Hospital
Adana, , Turkey (Türkiye)
Countries
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References
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Agarwal A, Yadav G, Gupta D, Singh PK, Singh U. Evaluation of intra-operative tramadol for prevention of catheter-related bladder discomfort: a prospective, randomized, double-blind study. Br J Anaesth. 2008 Oct;101(4):506-10. doi: 10.1093/bja/aen217. Epub 2008 Jul 24.
Binhas M, Motamed C, Hawajri N, Yiou R, Marty J. Predictors of catheter-related bladder discomfort in the post-anaesthesia care unit. Ann Fr Anesth Reanim. 2011 Feb;30(2):122-5. doi: 10.1016/j.annfar.2010.12.009. Epub 2011 Jan 31.
Ergenoglu P, Akin S, Yalcin Cok O, Eker E, Kuzgunbay B, Turunc T, Aribogan A. Effect of intraoperative paracetamol on catheter-related bladder discomfort: a prospective, randomized, double-blind study. Curr Ther Res Clin Exp. 2012 Dec;73(6):186-94. doi: 10.1016/j.curtheres.2012.08.001.
Other Identifiers
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KA08/180
Identifier Type: -
Identifier Source: org_study_id