Effect of preoperative given Dexketoprofen on Acute and ChronicPostcraniotomy Headache
Phase 1
- Conditions
- HeadacheTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]MedDRA version: 19.1Level: PTClassification code 10066965Term: Procedural headacheSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
- Registration Number
- EUCTR2017-000414-35-HU
- Lead Sponsor
- niversity of Debrecen Faculty of Medicine, Department of
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
18 years age or above
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 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
hypersensitivity to IMP
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Az egyszeri dózisban, premedikációban alkalmazott dexketoprofen a placébóhoz viszonyítva csökkenti-e az acut PCH gyakoriságát és annak intenzitását (elsodleges végpont).;Secondary Objective: Kutatásunk vizsgálni kívánja a betegek fájdalmait befolyásoló tényezoket, a szükséges analgetikumok összmennyiségét, az esetleges szövodményeket és a chronicus fejfájás gyakoriságát (másodlagos végpontok);Primary end point(s): 20% decrease in VAS Score compared to placebo;Timepoint(s) of evaluation of this end point: day 5, 30, 90 vizit
- Secondary Outcome Measures
Name Time Method Secondary end point(s): frquency of chronic headache;Timepoint(s) of evaluation of this end point: day 30. and day 90. visit