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Opioid-sparing Effect of Intravenous Ibuprofen

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ClinicalTrials.gov Identifier: NCT03016650
Recruitment Status : Unknown
Verified January 2017 by Muharrem Ucar, Inonu University.
Recruitment status was:  Not yet recruiting
First Posted : January 10, 2017
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Muharrem Ucar, Inonu University

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
Analgesia Percutaneous Nephrolithotomy Drug: Acetaminophen Drug: Ibuprofen 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2017
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Intrafen




Primary Outcome Measures :
  1. Morphine Consumption [ Time Frame: postoperatively 24 hours ]

Secondary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: postoperatively 30 minute, 2, 4, 6,12 and 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016650


Contacts
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Contact: Muharrem Ucar, Asst.Prof. +90 422 341 06 60 ext 3136 umuharrem@hotmail.com
Contact: Mehmet ALi ERDOGAN, Ass.Prof. +90 422 341 06 60 ext 6419 drmalierdogan@gmail.com

Sponsors and Collaborators
Muharrem Ucar
Investigators
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Principal Investigator: Muharrem Ucar İnonu University Faculty of Medicine
Publications of Results:
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Responsible Party: Muharrem Ucar, Principal Investigator, Inonu University
ClinicalTrials.gov Identifier: NCT03016650    
Other Study ID Numbers: muharrem-1
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Muharrem Ucar, Inonu University:
Acetaminophen
Ibuprofen
Additional relevant MeSH terms:
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Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action