Clincosm LogoSign in Get a demo

Opioid-sparing Effect of Intravenous Ibuprofen

Sponsor
Muharrem Ucar (Other)
Overall Status
Unknown status
CT.gov ID
NCT03016650
Collaborator
(none)
80
Enrollment
2
Arms
3.9
Duration (Months)

Study Details

Study Description

Brief Summary

The investigators aimed to evaluate tramadol-sparing effect of intravenous (IV) ibuprofen in patients undergoing percutaneous nephrolithotomy (PCNL).

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Eighty patients who will undergoing PCNL are randomized to intravenous paracetamol (n=40) and intravenous ibuprofen (n=40) groups. Patients will receive 100 mL of physiologic saline with 1 g IV paracetamol or 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL in the paracetamol and ibuprofen groups, respectively. Patients in both groups will receive intravenous tramadol with patient controlled analgesia device (PCA).

The visual analog scale (VAS) will used to evaluate pain intensity scores in the postoperative period.

Total tramadol consumption, mean VAS score in the 1, 8 and 24 hours, demographic variables, operative variables, and side effects will record.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Apr 1, 2017
Anticipated Study Completion Date :
May 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Paracetamol

Patients 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.

Drug: Acetaminophen
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
Other Names:
  • Perfalgan

    		•
    Active Comparator: ibuprofen

    Patients 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.

    Drug: Ibuprofen
    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
    Other Names:
  • Intrafen

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Morphine Consumption [postoperatively 24 hours]

    Secondary Outcome Measures

    1. Visual Analog Scale [postoperatively 30 minute, 2, 4, 6,12 and 24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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.
    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Muharrem Ucar

    Investigators

    • Principal Investigator: Muharrem Ucar, İnonu University Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Muharrem Ucar, Principal Investigator, Inonu University
    ClinicalTrials.gov Identifier:
    NCT03016650
    Other Study ID Numbers:
    • muharrem-1
    First Posted:
    Jan 10, 2017
    Last Update Posted:
    Jan 18, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Muharrem Ucar, Principal Investigator, Inonu University
    Acetaminophen
    Ibuprofen
    Additional relevant MeSH terms:
    Acetaminophen
    Ibuprofen

    Study Results

    No Results Posted as of Jan 18, 2017