Efficacy of Intravenous Dexketoprofen and Tenoxicam on Propofol Associated Injection Pain

NCT ID: NCT02285972

Last Updated: 2015-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-04-30

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.

Conditions

Injection Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

saline

Group Type: PLACEBO_COMPARATOR

saline

Intervention Type: DRUG

before the anesthesia induction, 2mL saline iv injection

dexketoprofen

Group Type: ACTIVE_COMPARATOR

dexketoprofen

Intervention Type: DRUG

before the anesthesia induction, 50 mg (2mL) iv dexketoprofen

tenoxicam

Group Type: ACTIVE_COMPARATOR

tenoxicam

Intervention Type: DRUG

before the anesthesia induction, 20 mg (2mL) iv tenoxicam

Interventions

saline

before the anesthesia induction, 2mL saline iv injection

Intervention Type: DRUG

dexketoprofen

before the anesthesia induction, 50 mg (2mL) iv dexketoprofen

Intervention Type: DRUG

tenoxicam

before the anesthesia induction, 20 mg (2mL) iv tenoxicam

Intervention Type: DRUG

Other Intervention Names

serum physiologic; Arveles; Leodex; Oksamen-L; Tilcotil

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ordu University

OTHER

Sponsor Role: lead

Responsible Party

özgür yağan

MD, assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital

Altinordu, Ordu, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Odu-5

Identifier Type: -

Identifier Source: org_study_id