Post operative craniotomy pain. postoperative pain post-craniotomy headache drug resistant epilepsy temporal lobectomy post-operatieve hoofdpijn craniotomie pijn resistente epilepsie temporale lobectomie
Conditions
Interventions
Patients are randomized by computer to receive either a 0.25mg/kg bolus s-ketamine followed by a continuous infusion of 0.1mg/kg/u s-ketamine or a placebo infusion (NaCl 0.9%) for 48 hours. The study
Sponsors
Maastricht Universitair Medisch Centrum
Department of Neurosurgery and Anesthesiology
Eligibility
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the total postoperative opioid consumption at the 7th postoperative day with interim measurements at 24, 48, 72 and 96 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the postoperative pain scores (VAS+NRS), patient health-related quality of life, psychological parameters, length of hospital stay and adverse events. | — |
Contacts
Public ContactJ.C.T. Sloekers
MUMC+
Outcome results
None listed