Efficacy of Intravenous Dexketoprofen and Tenoxicam on Propofol Associated Injection Pain

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 Overview

• Status: Completed
• Conditions: Injection Pain
• Intervention / Treatment: Drug: saline; Drug: dexketoprofen; Drug: tenoxicam

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Ordu
    • Altınordu, Ordu, Turkey, 52100
      • Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: saline	Drug: saline; before the anesthesia induction, 2mL saline iv injection; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Verbal Pain Score	Approximately one minute following administration of propofol.
Facial Pain Score	Approximately one minute following administration of propofol.

Collaborators and Investigators

• Sponsor: T.C. ORDU ÜNİVERSİTESİ

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: November 1, 2014
• First Submitted That Met QC Criteria: November 4, 2014
• First Posted (Estimate): November 7, 2014

Study Record Updates

• Last Update Posted (Estimate): April 21, 2015
• Last Update Submitted That Met QC Criteria: April 18, 2015
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Dexketoprofen trometamol; Tenoxicam
• Other Study ID Numbers: Odu-5