Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam
1 other identifier
interventional
90
1 country
1
Brief Summary
In this study the investigators aimed to compare of postoperative analgesic effects of intravenous dexketoprofen trometamol and tenoxicam in lumbar disc surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 postoperative-pain
Started Nov 2014
Shorter than P25 for phase_4 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2014
CompletedFirst Posted
Study publicly available on registry
June 10, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedNovember 10, 2014
November 1, 2014
3 months
June 8, 2014
November 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
analgesic consumption
morphine consumption (patient control analgesia procedure) was recorded
postoperative 1 day
Secondary Outcomes (1)
visual analog scale
postoperative 1 day
Study Arms (3)
dexketoprofen trometamol
ACTIVE COMPARATORbefore end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc
tenoxicam
ACTIVE COMPARATORbefore the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc
serum physiologic
PLACEBO COMPARATORbefore end of the surgery via administration intravenous 0.9 % NaCl 100 cc
Interventions
before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc
before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc
before end of the surgery via administration intravenous 0.9 % NaCl 100 cc
Eligibility Criteria
You may qualify if:
- ASA 1-2
- between 18-65 age
- elective lumbar disc surgery
You may not qualify if:
- history of gastrointestinal bleeding
- peptic ulcer disease
- bleeding disorders
- history of allergic reactions to NSAİDs
- chronic pain syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erciyes Universty Hospital
Kayseri, 38039, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
nazife küçük, resident
TC Erciyes University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident
Study Record Dates
First Submitted
June 8, 2014
First Posted
June 10, 2014
Study Start
November 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
November 10, 2014
Record last verified: 2014-11