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Trial record 2 of 11 for:    tenoxicam

Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam

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ClinicalTrials.gov Identifier: NCT02160236
Recruitment Status : Unknown
Verified November 2014 by Nazife Küçük, TC Erciyes University.
Recruitment status was:  Recruiting
First Posted : June 10, 2014
Last Update Posted : November 10, 2014
Sponsor:
Information provided by (Responsible Party):
Nazife Küçük, TC Erciyes University

Brief Summary:
In this study the investigators aimed to compare of postoperative analgesic effects of intravenous dexketoprofen trometamol and tenoxicam in lumbar disc surgery.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: dexketoprofen trometamol Drug: tenoxicam Drug: serum physiologic Phase 4

Detailed Description:
Lumbar disc surgery is associated with moderate to severe back and radicular pain postoperatively which has unfavorable effects on patients recovery and procedures outcome. Dexketoprofen has been reported to be one of the NSAİDs that can provide good results when compared with narcotics in many painful conditions and especially in the treatment of the moderate to severe postoperative pain that may develop after lumbal disc surgery. Tenoxicam is a thienothiazine derivative of the oxicam class of NSAİDs. There are some studies in which NSAİDs have been used to together with opioids for postoperative analgesia showing that they decrease opioid consumption and side effects

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam in Lumbar Disc Surgery
Study Start Date : November 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: dexketoprofen trometamol
before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc
Drug: dexketoprofen trometamol
before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc
Other Name: arveles

Active Comparator: tenoxicam
before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc
Drug: tenoxicam
before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc
Other Name: oksamen

Placebo Comparator: serum physiologic
before end of the surgery via administration intravenous 0.9 % NaCl 100 cc
Drug: serum physiologic
before end of the surgery via administration intravenous 0.9 % NaCl 100 cc




Primary Outcome Measures :
  1. analgesic consumption [ Time Frame: postoperative 1 day ]
    morphine consumption (patient control analgesia procedure) was recorded


Secondary Outcome Measures :
  1. visual analog scale [ Time Frame: postoperative 1 day ]
    visual analog scale on rest and movement was recorded



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA 1-2
  • between 18-65 age
  • elective lumbar disc surgery

Exclusion Criteria:

  • history of gastrointestinal bleeding
  • peptic ulcer disease
  • bleeding disorders
  • history of allergic reactions to NSAİDs
  • chronic pain syndrome

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): NCT02160236


Contacts
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Contact: Nazife Küçük, resident +905072317446 nzfkucuk@hotmail.com
Contact: Halit Madenoğlu, prof +903522076666 ext 24032 halitm@erciyes.edu.tr

Locations
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Turkey
Erciyes Universty Hospital Recruiting
Kayseri, Turkey, 38039
Contact: nazife küçük, resident    +905072317446    nzfkucuk@hotmail.com   
Sponsors and Collaborators
TC Erciyes University
Investigators
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Principal Investigator: nazife küçük, resident TC Erciyes University

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Responsible Party: Nazife Küçük, resident, TC Erciyes University
ClinicalTrials.gov Identifier: NCT02160236     History of Changes
Other Study ID Numbers: 2013/469
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: November 10, 2014
Last Verified: November 2014
Keywords provided by Nazife Küçük, TC Erciyes University:
dexketoprofen trometamol
tenoxicam
postoperative pain
Additional relevant MeSH terms:
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Tenoxicam
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexketoprofen trometamol
Ketoprofen
Piroxicam
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action