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Efficacy of Intravenous Dexketoprofen and Tenoxicam on Propofol Associated Injection Pain

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ClinicalTrials.gov Identifier: NCT02285972
Recruitment Status : Completed
First Posted : November 7, 2014
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
özgür yağan, T.C. ORDU ÜNİVERSİTESİ

Brief Summary:
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 or disease Intervention/treatment Phase
Injection Pain Drug: saline Drug: dexketoprofen Drug: tenoxicam Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : November 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
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




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


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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:

  • 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

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

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 Posted: November 7, 2014    Key Record Dates
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