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Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam

NCT ID: NCT02160236

Last Updated: 2014-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-02-28

Brief Summary

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

Detailed Description

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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

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dexketoprofen trometamol

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

Group Type ACTIVE_COMPARATOR

dexketoprofen trometamol

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

tenoxicam

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

serum physiologic

Intervention Type DRUG

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

Interventions

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dexketoprofen trometamol

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

Intervention Type DRUG

tenoxicam

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

Intervention Type DRUG

serum physiologic

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

Intervention Type DRUG

Other Intervention Names

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arveles oksamen

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Nazife Küçük

resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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nazife küçük, resident

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

Locations

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Erciyes Universty Hospital

Kayseri, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Nazife Küçük, resident

Role: CONTACT

[email protected]
+905072317446

Halit Madenoğlu, prof

Role: CONTACT

[email protected]
+903522076666 ext. 24032

Facility Contacts

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nazife küçük, resident

Role: primary

[email protected]
+905072317446

Other Identifiers

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2013/469

Identifier Type: -

Identifier Source: org_study_id