What side effects are associated with this type of intervention?

Common treatments for hemorrhoids include topical ointments, oral pain relievers, and surgical interventions. Topical treatments like glyceryl trinitrate ointment may cause headaches. Oral pain relievers such as NSAIDs (e.g., ibuprofen, ketorolac) can lead to gastrointestinal issues, including ulcers and bleeding. Surgical treatments, including hemorrhoidectomy, can result in postoperative pain, which may be managed with anesthetics like ketamine. Ketamine, while effective for pain relief, can cause side effects such as hallucinations, dizziness, and increased blood pressure. Overall, the side effects of hemorrhoid treatments vary depending on the method used, but they generally include local irritation, gastrointestinal disturbances, and potential systemic effects from anesthetics.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for hemorrhoids similar to ketamine in the provided context. Generally, hemorrhoid treatments include over-the-counter topical treatments like hydrocortisone creams, suppositories, and pads, as well as prescription medications for more severe cases. Surgical options and minimally invasive procedures are also common. Ketamine, primarily used as an anesthetic and analgesic, is not typically associated with hemorrhoid treatment.

What other types of research exist?

Promising alternatives to ketamine for hemorrhoid patients include: 1) Neuraxial anesthesia techniques such as epidural or spinal anesthesia, which have been associated with reduced perioperative morbidity. 2) Non-opioid pharmacotherapies like intravenous acetaminophen and NSAIDs (e.g., ketorolac, diclofenac) that provide effective postoperative pain relief. 3) Regional anesthesia techniques like transversus abdominis plane (TAP) blocks, which have shown efficacy in managing postoperative pain in minimally invasive surgeries.

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Ketamine for Hemorrhoids

Phase 4

Recruiting

Led By Steven N Carter, MD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-op days 1, 3, 5, 7, and 10

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial tests if ketamine can help reduce pain in patients having surgery for severe hemorrhoids. Ketamine is given during the operation to block pain signals in the brain. The study compares patients who receive ketamine with those who do not. Ketamine has been studied for its potential to reduce postoperative pain and opioid consumption, but results have been mixed.

Who is the study for?

This trial is for adults aged 18-100 who are having surgery (hemorrhoidectomy) for severe hemorrhoids (Grade III or IV). They must be able to have general anesthesia and not use strong painkillers regularly. People with a history of schizophrenia, other hallucinatory psychiatric illnesses, or psychosis cannot participate.

What is being tested?

The study is testing if ketamine can help with pain after hemorrhoid surgery. About 100 patients will either receive ketamine or no ketamine while under anesthesia, without knowing which group they're in; however, the researchers will know.

What are the potential side effects?

Ketamine may cause side effects such as feelings of disconnection from reality, changes in perception like sights and sounds, confusion, agitation, elevated blood pressure and heart rate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two weeks post-operation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two weeks post-operation

This trial's timeline: 3 weeks for screening, Varies for treatment, and two weeks post-operation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in post-operative narcotic usage

Secondary study objectives

Change in post-op pain

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Intraoperative ketamine infusionActive Control1 Intervention

Subjects in this group will receive standard anesthesia during surgery and a dose of ketamine at 0.3 mg/kg IV bolus prior to surgical incision. If the procedure lasts more than 1 hour, an additional bolus dose will be given.

Group II: Control groupActive Control1 Intervention

This group will only receive the standard anesthesia during surgery with no ketamine.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Hemorrhoid treatments often focus on reducing pain, inflammation, and swelling. Anesthetics like ketamine work by blocking NMDA receptors in the brain, which helps in reducing pain perception and providing analgesia. This is particularly useful for hemorrhoid patients undergoing surgical procedures, as it can help manage postoperative pain effectively. Other common treatments include NSAIDs, which reduce inflammation by inhibiting cyclooxygenase enzymes, and corticosteroids, which decrease inflammation and immune response. Understanding these mechanisms is crucial for hemorrhoid patients as it helps in selecting the most appropriate treatment to manage symptoms effectively and improve recovery outcomes.