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The effect of perioperative intravenous s-ketamine on acute and chronic postoperative craniotomy pain compared to placebo
EU CTIS ID: 2024-514020-16-00
What this study is testing
The aim of this study is to investigate the effect of adding s-ketamine to a multimodal pain approach of acetaminophen and opioids compared to placebo with the same multimodal pain approach, on total opioid consumption after craniotomy in patients with drug-resistant temporal lobe epilepsy. The total opioid consumption will be measured 5 times in the first 7 days after operation.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age > 18 years
- Elective resective surgery for drug-resistant temporal lobe epilepsy
- Drug-resistant epilepsy, based on: o chronic, focal epilepsy o not seizure free with antiepileptic medication o no medication options due to adverse effects
- Signed informed consent for trial participation
You likely can't join if
- 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
See the full eligibility criteria
- Age > 18 years
- Elective resective surgery for drug-resistant temporal lobe epilepsy
- Drug-resistant epilepsy, based on: o chronic, focal epilepsy o not seizure free with antiepileptic medication o no medication options due to adverse effects
- Signed informed consent for trial participation
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.