Efficacy of Intravenous Dexketoprofen and Tenoxicam on Propofol Associated Injection Pain

Injection Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02285972
• Other study ID #: Odu-5
• Status: Completed
• Phase: Phase 4
• First received: November 1, 2014
• Last updated: April 18, 2015
• Start date: November 2014
• Est. completion date: April 2015

Study information

• Verified date: November 2014
• Source: T.C. ORDU ÜNIVERSITESI
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Injection Pain

Intervention

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

Locations

Country	Name	City	State
Turkey	Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital	Altinordu	Ordu

Sponsors (1)

Lead Sponsor	Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verbal Pain Score		Approximately one minute following administration of propofol.	No
Primary	Facial Pain Score		Approximately one minute following administration of propofol.	No