Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam

Postoperative Pain Clinical Trial

Official title:

Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam in Lumbar Disc Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02160236
• Other study ID #: 2013/469
• Status: Recruiting
• Phase: Phase 4
• First received: June 8, 2014
• Last updated: November 7, 2014
• Start date: November 2014
• Est. completion date: February 2015

Study information

• Verified date: November 2014
• Source: TC Erciyes University
• Contact: Nazife Küçük, resident
• Phone: +905072317446
• Email: nzfkucuk[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

In this study the investigators aimed to compare of postoperative analgesic effects of intravenous dexketoprofen trometamol and tenoxicam in lumbar disc surgery.

Description:

Lumbar disc surgery is associated with moderate to severe back and radicular pain postoperatively which has unfavorable effects on patients recovery and procedures outcome. Dexketoprofen has been reported to be one of the NSAİDs that can provide good results when compared with narcotics in many painful conditions and especially in the treatment of the moderate to severe postoperative pain that may develop after lumbal disc surgery. Tenoxicam is a thienothiazine derivative of the oxicam class of NSAİDs. There are some studies in which NSAİDs have been used to together with opioids for postoperative analgesia showing that they decrease opioid consumption and side effects

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA 1-2

• between 18-65 age

• elective lumbar disc surgery

Exclusion Criteria:

• history of gastrointestinal bleeding

• peptic ulcer disease

• bleeding disorders

• history of allergic reactions to NSAIDs

• chronic pain syndrome

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• dexketoprofen trometamol
before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc
• tenoxicam
before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc
• serum physiologic
before end of the surgery via administration intravenous 0.9 % NaCl 100 cc

Locations

Country	Name	City	State
Turkey	Erciyes Universty Hospital	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analgesic consumption	morphine consumption (patient control analgesia procedure) was recorded	postoperative 1 day	No
Secondary	visual analog scale	visual analog scale on rest and movement was recorded	postoperative 1 day	No