100 Participants Needed

Ketamine for Hemorrhoids

Recruiting at 1 trial location
SN
TJ
Overseen ByTheresa J Lander
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Oklahoma
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are using narcotics regularly, you must stop at least one month before the hemorrhoidectomy.

Is ketamine generally safe for humans?

Ketamine is generally safe for humans, but it can cause side effects like a sense of detachment from reality and increased blood pressure. Chronic use may lead to bladder and bile duct issues.12345

How does the drug ketamine differ from other treatments for hemorrhoids?

Ketamine is unique because it is typically used as an anesthetic and pain reliever, often administered through injections or oral forms like gels or lollipops, which is different from standard hemorrhoid treatments that usually involve topical creams or surgical procedures. Its use for hemorrhoids is novel, as it leverages ketamine's pain-relieving properties in a new context.678910

What data supports the effectiveness of the drug ketamine for treating hemorrhoids?

Research shows that ketamine can reduce pain and depression in various medical settings, such as surgery and cancer treatment, which suggests it might help with pain management in hemorrhoids. However, there is no direct evidence specifically for hemorrhoids.611121314

Who Is on the Research Team?

SN

Steven Carter, MD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Adults aged 18-100
You recently had surgery to remove severe hemorrhoids (Grade III or IV).

Exclusion Criteria

Inability to undergo general anesthesia
Chronic narcotic usage defined as either having a pain contract with a pain management specialist and no narcotic usage for one month prior to hemorrhoidectomy.
You have medical conditions that make it unsafe for you to have a hemorrhoidectomy (surgical removal of hemorrhoids).
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo hemorrhoidectomy with either intraoperative ketamine infusion or standard anesthesia

1 day
1 visit (in-person, surgery)

Post-operative Monitoring

Participants' post-operative pain is assessed using a numeric rating scale and the Wong-Baker FACES pain scale

2 weeks
1 visit (in-person), multiple contacts (phone)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of narcotic usage

2 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Ketamine
Trial Overview 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.
How Is the Trial Designed?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

Published Research Related to This Trial

In a study of 268 procedures involving 35 children with leukemia, the combination of thiamylal plus pentazocine (TP) provided faster sedation compared to ketamine plus midazolam (KM) during bone marrow aspirations and intrathecal chemotherapy.
While TP was associated with a higher incidence of transient desaturation events, these were manageable with oxygen supplementation, indicating that TP can be a safe and effective alternative for sedation in pediatric oncology procedures.
Thiamylal Plus Pentazocine Shows Similar Efficacy as Ketamine Plus Midazolam for Painful Procedures in Children With Leukemia.Nakagawa, S., Okamoto, Y., Kodama, Y., et al.[2019]
Adding ketamine to caudal local anaesthetics significantly prolongs the time before children need their first pain relief after surgery, with an average increase of 5.60 hours compared to local anaesthetics alone, based on a review of 13 randomized controlled trials involving 584 patients.
While ketamine reduces the need for additional pain relief (rescue analgesia), concerns about potential neurotoxicity and the appropriate dosing in children remain, indicating that further research is needed before widespread clinical use.
Efficacy and adverse effects of ketamine as an additive for paediatric caudal anaesthesia: a quantitative systematic review of randomized controlled trials.Schnabel, A., Poepping, DM., Kranke, P., et al.[2022]
A meta-analysis of 15 studies involving 1697 patients showed that perioperative intravenous ketamine significantly reduces postoperative depression scores, with the most substantial effects observed on the first day after surgery (SMD -0.97).
While ketamine also decreased pain scores on the first postoperative day, it was associated with a higher risk of adverse effects, including nausea, vomiting, headaches, hallucinations, and dizziness.
Efficacy and safety of perioperative application of ketamine on postoperative depression: A meta-analysis of randomized controlled studies.Guo, J., Qiu, D., Gu, HW., et al.[2023]

Citations

Thiamylal Plus Pentazocine Shows Similar Efficacy as Ketamine Plus Midazolam for Painful Procedures in Children With Leukemia. [2019]
Efficacy and adverse effects of ketamine as an additive for paediatric caudal anaesthesia: a quantitative systematic review of randomized controlled trials. [2022]
Efficacy and safety of perioperative application of ketamine on postoperative depression: A meta-analysis of randomized controlled studies. [2023]
Intravenous ketamine infusion for a patient with treatment-resistant major depression: a 10-month follow-up. [2018]
A review of the clinical applications of ketamine in pediatric oncology. [2021]
Influence of formulation and route of administration on ketamine's safety and tolerability: systematic review. [2021]
Three Birds, One Excipient: Development of an Improved pH, Isotonic, and Buffered Ketamine Formulation for Subcutaneous Injection. [2022]
The Ketamine Side Effect Tool (KSET): A comprehensive measurement-based safety tool for ketamine treatment in psychiatry. [2023]
Lower urinary tract changes in young adults using ketamine. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Recreational ketamine-induced cholangiopathy and ulcerative cystitis. [2021]
[Ketamine lollipop for pediatric premedication]. [2013]
Evaluation of relatively low dose of oral transmucosal ketamine premedication in children: a comparison with oral midazolam. [2022]
Influence of premedication with xylazine on the distribution and metabolism of intramuscularly administered ketamine in cats. [2016]
[Preparing oral dosage form of ketamine in the hospital for simplicity and patient compliance--preparations using agar]. [2019]
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