Magnesium and Ketamine for Post-Operative Pain After Hysteroscopy
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, including magnesium, pain relievers, antidepressants, anti-anxiety medications, and opioids, before participating.
What data supports the effectiveness of the drug for post-operative pain after hysteroscopy?
Research shows that both ketamine and magnesium sulfate can help reduce pain and the need for opioids (strong painkillers) after surgery. They work by blocking certain receptors in the body that are involved in pain sensation, which can help manage pain more effectively during and after procedures like hysteroscopy.12345
Is the combination of magnesium and ketamine safe for use in humans?
How does the drug combination of magnesium and ketamine differ from other treatments for post-operative pain after hysteroscopy?
The combination of magnesium and ketamine is unique because both drugs can block NMDA receptors, which helps in providing pain relief without the side effects commonly associated with opioids, such as respiratory depression and nausea. This combination may reduce the need for opioids and their related side effects during and after hysteroscopy.23456
What is the purpose of this trial?
Hysteroscopy (an exam to look inside the uterus) is one of the most frequently performed procedures for patients with cervical or uterine disorders. It is the gold standard for evaluating various intrauterine problems, pre-menopausal and post-menopausal abnormal uterine bleeding, as well as being a vital examination modality for infertility work-up. Although hysteroscopy is a minimally invasive procedure, it is still known to be a painful experience that requires effective analgesia (meaning pain reduction) to achieve maximum patient comfort and cooperation. Historically, opioids, particularly fentanyl, have held precedence as the primary agents for providing analgesia following surgery of this type. However, despite their efficacy, these agents come with notable drawbacks, including the potential for serious side effects such as respiratory depression, addiction, and postoperative nausea and vomiting.Both magnesium and ketamine are routinely used to reduce pain following this procedure. Both drugs work on the N-methyl-D-aspartate (NMDA) receptor in the brain to reduce pain, and magnesium has an additional effect in that it can relax smooth muscles. Magnesium has been used successfully to reduce the pain associated with menstrual cramps, which is similar to the pain patients experience after hysteroscopy.A recent study demonstrated the benefits of adding intravenous magnesium with routine anesthesia during hysteroscopy, revealing a significant decrease in postoperative pain and rescue analgesics. However, this study did not compare the effects of magnesium to ketamine, nor did they characterize the nature of the patients' pain. It is unclear if the pain reduction with magnesium comes from its effect on the NMDA receptor or from it's cramp-reduction effect. We seek to establish whether administering IV magnesium, compared to ketamine, can specifically mitigate uterine cramping pain and total opioid consumption in hopes of finding additional safe and effective pain modalities for patients.This is a prospective, randomized trial enrolling participants undergoing an elective hysteroscopy or Dilation and Curettage (D\&C) at Corewell Health William Beaumont University Hospital in Royal Oak. Participants will be randomized to 1 of 3 treatments: Intravenous (IV) Magnesium, IV Push Ketamine, or Placebo. Opioid consumption is recorded via the electronic medical record (EMR), while overall pain and cramping pain will be captured post-procedure in the hospital and 24 hours later via a phone call.
Research Team
Ray Soto, MD
Principal Investigator
William Beaumont Hospitals
Eligibility Criteria
This trial is for patients undergoing elective hysteroscopy or D&C at Corewell Health William Beaumont University Hospital. Participants must be eligible for the procedure and willing to receive IV Magnesium, IV Ketamine, or a placebo as part of their pain management.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative
Discussion of the study and obtaining consent, collection of baseline data
Treatment
Participants undergo hysteroscopy with randomized administration of IV magnesium, ketamine, or placebo
Post-operative Monitoring
Pain and opioid consumption are monitored and recorded post-procedure
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ketamine
- Magnesium sulfate
Find a Clinic Near You
Who Is Running the Clinical Trial?
William Beaumont Hospitals
Lead Sponsor