Clinical Trials for Procedural Headache
Currently, there is 1 ongoing clinical trial focused on procedural headache, specifically post-craniotomy headache following brain surgery for drug-resistant temporal lobe epilepsy. This trial is investigating whether the medication Esketamine can improve pain management and reduce the need for opioid pain relievers after surgery.
Clinical trial locations
Study on the Effect of Esketamine and Sodium Chloride on Post-Craniotomy Headache in Patients with Drug-Resistant Temporal Lobe Epilepsy
This clinical trial is examining whether Esketamine can help reduce pain after brain surgery in patients with drug-resistant temporal lobe epilepsy. The surgery, called a craniotomy, involves removing part of the skull to access the brain. After such surgery, patients often experience headaches, and this study aims to find better ways to manage that pain.
Main focus of the trial: The primary goal is to determine whether adding Esketamine to standard pain management can reduce the amount of opioid pain medications needed in the first week after surgery. Researchers will monitor how much pain medication patients use at 24, 48, 72, and 96 hours after surgery, and again on the seventh day. The trial will also assess hospital stay length, quality of life, psychological well-being, side effects, and pain levels using standard rating scales.
Investigational drugs: The study uses Esketamine (also called S-ketamine), which is given through an intravenous infusion directly into the bloodstream. This medication works by blocking certain receptors in the brain involved in pain perception. It is being tested alongside standard pain management, which includes acetaminophen (a common pain reliever) and opioids (strong pain medications). The trial also uses sodium chloride (salt water) as a placebo for comparison.
Who can participate – Inclusion criteria:
- Adults over 18 years of age
- Scheduled for planned brain surgery to treat drug-resistant temporal lobe epilepsy, which means epilepsy that does not improve with medication
- Have long-term, focused seizures that do not stop with medication and cannot become seizure-free with current treatment options
- Must provide signed informed consent agreeing to participate
Who cannot participate – Exclusion criteria:
- Serious allergy to any of the study medications
- Pregnant or breastfeeding
- History of substance abuse or addiction to drugs or alcohol
- Participated in another clinical trial within the last 30 days
- Severe liver or kidney disease where these organs do not work properly
- Uncontrolled high blood pressure not managed by medication or lifestyle changes
- History of severe mental health disorders such as schizophrenia or bipolar disorder
- Stroke or heart attack in the past 6 months
- Active infections requiring antibiotic treatment
- Unable to follow study procedures or attend follow-up visits
Summary
There is currently 1 active clinical trial investigating procedural headache, specifically the type that occurs after craniotomy surgery. This trial is taking place in the Netherlands and focuses on patients with drug-resistant temporal lobe epilepsy. The research is centered on Esketamine, a medication that may help reduce the need for strong opioid pain relievers after surgery. The trial reflects an important effort to find safer and more effective pain management strategies for patients undergoing complex brain surgery.