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Efficacy of Intravenous Dexketoprofen and Tenoxicam on Propofol Associated Injection Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285972
First Posted: November 7, 2014
Last Update Posted: April 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
özgür yağan, T.C. ORDU ÜNİVERSİTESİ
  Purpose
Propofol remains the most common drug for induction of general anaesthesia, although it causes considerable pain or discomfort on injection. Anesthesia providers have attempted a large number of remedies to prevent this pain on injection. Previously explored ideas include injecting propofol into larger veins, warming of the hand with hot packs, and intravenous pretreatment with numerous other medications. No studies to date have looked at the dexketoprofen and tenoxicam for the pretreatment of pain on injection caused by propofol. The investigators propose studying the use of dexketoprofen and tenoxicam for pretreatment of propofol related pain on injection.

Condition Intervention Phase
Injection Pain Drug: saline Drug: dexketoprofen Drug: tenoxicam Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention

Further study details as provided by özgür yağan, T.C. ORDU ÜNİVERSİTESİ:

Primary Outcome Measures:
  • Verbal Pain Score [ Time Frame: Approximately one minute following administration of propofol. ]
  • Facial Pain Score [ Time Frame: Approximately one minute following administration of propofol. ]

Enrollment: 118
Study Start Date: November 2014
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: saline Drug: saline
before the anesthesia induction, 2mL saline iv injection
Other Name: serum physiologic
Active Comparator: dexketoprofen Drug: dexketoprofen
before the anesthesia induction, 50 mg (2mL) iv dexketoprofen
Other Names:
  • Arveles
  • Leodex
Active Comparator: tenoxicam Drug: tenoxicam
before the anesthesia induction, 20 mg (2mL) iv tenoxicam
Other Names:
  • Oksamen-L
  • Tilcotil

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status 1 and 2
  • 18 - 65 years
  • general anesthesia scheduled for elective surgery

Exclusion Criteria:

  • age < 18 years, > 65 years
  • pregnancy
  • patients requiring a rapid sequence induction
  • refusal to participate and patients already participating in another study
  • allergy to study drugs
  • communication difficulty
  • psychiatric and neurolojic disorders
  • use of analgesics or sedative drugs within 24 hours before surgery.
  • emergency surgery
  • history of drug or alcohol abuse
  • ASA 3 and above
  Contacts and Locations
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): NCT02285972


Locations
Turkey
Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital
Altınordu, Ordu, Turkey, 52100
Sponsors and Collaborators
T.C. ORDU ÜNİVERSİTESİ
  More Information

Responsible Party: özgür yağan, MD, assistant professor, T.C. ORDU ÜNİVERSİTESİ
ClinicalTrials.gov Identifier: NCT02285972     History of Changes
Other Study ID Numbers: Odu-5
First Submitted: November 1, 2014
First Posted: November 7, 2014
Last Update Posted: April 21, 2015
Last Verified: November 2014

Additional relevant MeSH terms:
Tenoxicam
Piroxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action