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S-ketamine for acute and chronic headache after brainsurgery

Phase 1
Conditions
Post operative craniotomy pain
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Registration Number
EUCTR2017-002616-13-NL
Lead Sponsor
Maastricht Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
62
Inclusion Criteria

- Age > 18 years
- Elective resective surgery for drug-resistant temporal lobe epilepsy
- Drug-resistant epilepsy, based on: (1) chronic, focal epilepsy; (2) not seizure free with antiepileptic medication; (3) no medication options due to adverse effects
- Signed informed consent for trial participation
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 62
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Declined informed consent
- Allergy to any of the trial medications
- Current chronic pain, such as, but not limiting to, migraine or other headaches.
- Chronic pain treatment with use of different kinds of pain medication.
- Alcohol, hard- or soft drug abuses
- Inability to complete questionnaires or language barrier
- History of psychiatric complaints for which treatment was performed
- History of craniotomy or subdural electrode implantation

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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