Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam

TC Erciyes University

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: dexketoprofen trometamol; Drug: serum physiologic; Drug: tenoxicam

Study type: Interventional

Funder types: Other

Identifiers

NCT02160236

2013/469

Details and patient eligibility

About

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

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 NSAİDs
• chronic pain syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

dexketoprofen trometamol

Active Comparator group

Description:

before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc

Treatment:

Drug: dexketoprofen trometamol

tenoxicam

Active Comparator group

Description:

before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc

Treatment:

Drug: tenoxicam

serum physiologic

Placebo Comparator group

Description:

before end of the surgery via administration intravenous 0.9 % NaCl 100 cc

Treatment:

Drug: serum physiologic