Efficacy of Intravenous Dexketoprofen and Tenoxicam on Propofol Associated Injection Pain

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: April 2015

Interventions

  • Drug: saline
    • before the anesthesia induction, 2mL saline iv injection
  • Drug: dexketoprofen
    • before the anesthesia induction, 50 mg (2mL) iv dexketoprofen
  • Drug: tenoxicam
    • before the anesthesia induction, 20 mg (2mL) iv tenoxicam

Arms, Groups and Cohorts

  • Placebo Comparator: saline
  • Active Comparator: dexketoprofen
  • Active Comparator: tenoxicam

Clinical Trial Outcome Measures

Primary 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • T.C. ORDU ÜNİVERSİTESİ
  • Provider of Information About this Clinical Study
    • Principal Investigator: özgür yağan, MD, assistant professor – T.C. ORDU ÜNİVERSİTESİ

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