Methadone vs Remifentanil for Pain in Craniotomy Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two drugs, methadone and remifentanil, to determine which better manages pain after brain surgery. The goal is to assess if a single dose of methadone can control pain as effectively as remifentanil, typically administered in smaller, repeated doses. Success with methadone might reduce the need for additional pain medications post-surgery. Individuals who have undergone brain surgery and experience pain may be suitable candidates, particularly if they have not regularly used opioids before surgery. As an Early Phase 1 trial, this research aims to understand how these treatments work in people, offering participants a chance to contribute to innovative pain management strategies.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using methadone or have a chronic pain condition requiring daily opioid use.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both methadone and remifentanil are generally safe and effective for pain management. Studies indicate that a single dose of IV methadone during surgery is well-tolerated by patients undergoing various types of brain surgeries, with only a few side effects. Patients experienced less pain and required fewer painkillers afterward.
Research has also found remifentanil to be a safe option during surgeries, including brain surgeries, and it has been used effectively without causing major problems. This suggests that remifentanil is a good choice for controlling pain during and after surgery.
Both treatments have demonstrated strong safety records in other surgeries, making them promising options for managing pain during craniotomy surgeries.12345Why are researchers excited about this trial's treatments?
Researchers are excited about methadone for pain management during craniotomy surgery because it offers a unique approach compared to standard options like remifentanil. Unlike many anesthetics that require continuous titration, methadone allows for a single, pre-incision intravenous dose, which may streamline the anesthesia process and reduce the need for constant adjustments. Additionally, methadone has a longer-lasting effect, potentially providing more sustained pain relief post-surgery. This could lead to improved patient comfort and a smoother recovery process compared to traditional methods.
What evidence suggests that this trial's treatments could be effective for postoperative pain in craniotomy surgery?
This trial will compare the effectiveness of Methadone and Remifentanil for managing pain in craniotomy surgery. Research has shown that Methadone, which participants in this trial may receive, effectively manages post-surgical pain and reduces the need for additional pain medication in various surgeries, including brain surgeries. Patients who receive Methadone report less pain and require fewer painkillers for up to 72 hours after surgery. Methadone is promising due to its long duration and ability to block certain pain signals.
In contrast, Remifentanil, another treatment option in this trial, provides quick and effective pain relief during brain surgeries. It is often used for its rapid action and ability to maintain stable conditions during the operation. Both treatments aim to manage pain effectively, but Methadone might offer longer-lasting relief.12456Are You a Good Fit for This Trial?
This trial is for patients undergoing craniotomy surgery who need effective pain control post-operation. The study aims to include those who could benefit from long-lasting pain relief without the risk of respiratory depression, which is crucial after brain surgery.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either IV methadone or IV remifentanil during craniotomy surgery
Postoperative Monitoring
Participants are monitored for pain control and recovery quality using various scales over 72 hours post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Methadone
- Remifentanil
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor