EUCTR2017-004711-39-FIActive, not recruitingPhase 1
Tramadol-paracetamol in spine surgery
Merja Kokki0 sites120 target enrollmentStarted: March 9, 2018Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •18-75-year old patient undergoing elective spine surgery
- •BMI 18-35 kg/m2
- •Participants must understand the meaning of the study, and the procedures, and provide informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
Exclusion Criteria
- •Age<18 years or >75 years
- •Hypersensitivity to ibuprofen, other non-steroidal anti-inflammatory drugs, paracetamol, tramadol or their exipients
- •Astma, urticaria or allergic reaction to ASA/NSAIDs
- •Acute bleeding or history if hemorrhage in gastrointestinal tract or peptic ulcer
- •Bleeding disorder
- •Use of nonoamineoxidase inhibitors within last two weeks
- •Severe hepatic impairment.
- •Epilepsy not controlled by treatment
- •Patients susceptible to seizures or taking other medications that lower the seizure threshold
- •Severe liver or renal failure
- •Severe respiratory impairment
- •Severe cardiac insufficiency
- •History or acute intoxication with alcohol, hypnotic medicinal products, centrally-acting analgesics, opioids or psychotropic medicinal products
- •Pregnancy or breastfeeding
- •Other reason investigator estimates prelude participation
Investigators
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