150 Participants Needed

Magnesium and Ketamine for Post-Operative Pain After Hysteroscopy

RS
PS
Overseen ByPamela Sloan, RN, BSN
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Research shows that both ketamine and magnesium sulfate have been used safely in various medical procedures, including hysteroscopy and endoscopy, to manage pain and sedation. However, as with any medication, they can have side effects, so it's important to use them under medical supervision.12467

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

RS

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

I am scheduled for a hysteroscopy or D&C procedure.
My health is good to moderately impaired according to ASA standards.

Exclusion Criteria

I have been taking opioids for chronic pain within the last week.
Allergies to any of the medications that will be administered
Pregnant women
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (phone call)

Pre-operative

Discussion of the study and obtaining consent, collection of baseline data

1 day
1 visit (in-person)

Treatment

Participants undergo hysteroscopy with randomized administration of IV magnesium, ketamine, or placebo

Intra-operative
1 visit (in-person)

Post-operative Monitoring

Pain and opioid consumption are monitored and recorded post-procedure

24 hours
1 visit (in-person), 1 follow-up call

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 hours
1 follow-up call

Treatment Details

Interventions

  • Ketamine
  • Magnesium sulfate
Trial Overview The study aims to compare the effectiveness of IV Magnesium and IV Ketamine against a placebo in reducing uterine cramping pain and total opioid use after hysteroscopy. It's a randomized trial where participants are assigned one of these three treatments by chance.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Magnesium, IVExperimental Treatment1 Intervention
Intravenous magnesium 2 grams given over 20 minutes intra-operatively
Group II: Ketamine, IVExperimental Treatment1 Intervention
Intravenous ketamine 0.5 milligrams per kilogram dosed to ideal bodyweight, IV push intra-operatively
Group III: PlaceboPlacebo Group1 Intervention
No administration of placebo infusion, ketamine or magnesium intra-operatively

Find a Clinic Near You

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials
153
Recruited
113,000+

References

1.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Comparison of the Sedative Effect of Ketamine, Magnesium Sulfate, and Propofol in Patients Undergoing Upper Gastrointestinal Endoscopy: Double-Blinded Randomized Clinical Trial [2023]
Low-Dose Ketamine for Outpatient Hysteroscopy: A Prospective, Randomised, Double-Blind Study. [2022]
Comparison of the effects of magnesium and ketamine on postoperative pain and morphine consumption. A double-blind randomized controlled clinical study. [2022]
Antinociceptive effects of magnesium sulfate for monitored anesthesia care during hysteroscopy: a randomized controlled study. [2021]
Magnesium and Ketamine Gargle and Postoperative Sore Throat. [2022]
[Effects of intraarticular tramadol, magnesium and ketamine on postoperative pain in arthroscopic meniscectomy]. [2022]
A comparison of gabapentin and ketamine in acute and chronic pain after hysterectomy. [2022]
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