Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
NCT06745388

Magnesium and Cramping

Led by Corewell Health East · Updated on 2025-08-20

150

Participants Needed

1

Research Sites

57 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Magnesium and Cramping

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing an elective hysteroscopy or dilation and curettage (D&C)
  • American Society of Anesthesiologists (ASA) Physical Status 1 - 3
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Chronic Pain Patients (taking opioids within one week of procedure)
  • Psychiatric Disorders (current treatment for anxiety/depression)
  • Allergies to any of the medications that will be administered
  • Current use of magnesium, analgesics, antidepressants, anxiolytics, or opioids
  • ASA Physical Status 4 or above
  • Developmentally delayed patients that would not be able to verbalize pain scores
  • Minors (under 18 years of age)
  • Pregnant women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States, 48073

Actively Recruiting

Loading map...

Research Team

R

Ray Soto, MD

CONTACT

P

Pamela Sloan, RN, BSN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here