Opioid-sparing Effect of Intravenous Ibuprofen
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
The investigators aimed to evaluate tramadol-sparing effect of intravenous (IV) ibuprofen in patients undergoing percutaneous nephrolithotomy (PCNL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2017
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 9, 2017
CompletedFirst Posted
Study publicly available on registry
January 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedJanuary 18, 2017
January 1, 2017
3 months
January 9, 2017
January 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morphine Consumption
postoperatively 24 hours
Secondary Outcomes (1)
Visual Analog Scale
postoperatively 30 minute, 2, 4, 6,12 and 24 hours
Study Arms (2)
Paracetamol
ACTIVE COMPARATORPatients will receive 100 mL of physiologic saline with 1 g IV acetaminophen (paracetamol) 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after percutaneous nephrolithotomy, respectively.
ibuprofen
ACTIVE COMPARATORPatients will receive 100 mL of physiologic saline with 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after percutaneous nephrolithotomy, respectively.
Interventions
Patients receive 100 mL of physiologic saline with 1 g IV paracetamol 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL
Patients receive 100 mL of physiologic saline with 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL
Eligibility Criteria
You may qualify if:
- Study include 80 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-70 years who scheduled for percutaneous nephrolithotomy operation.
You may not qualify if:
- chronic pain,
- psychiatric disease,
- renal dysfunction,
- allergy to nonsteroidal anti-inflammatory drugs,
- history of drug addiction,
- pregnancy,
- inability to use a patient controlled analgesia (PCA) device.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Muharrem Ucarlead
Related Publications (1)
Maghsoudi R, Tabatabai M, Radfar MH, Movasagi G, Etemadian M, Shati M, Amjadi M. Opioid-sparing effect of intravenous paracetamol after percutaneous nephrolithotomy: a double-blind randomized controlled trial. J Endourol. 2014 Jan;28(1):23-7. doi: 10.1089/end.2013.0267. Epub 2013 Oct 17.
PMID: 23952097RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muharrem Ucar
İnonu University Faculty of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 9, 2017
First Posted
January 10, 2017
Study Start
January 1, 2017
Primary Completion
April 1, 2017
Study Completion
May 1, 2017
Last Updated
January 18, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share