Recruiting

Magnesium vs. Ketamine

Sponsor:

William Beaumont Hospitals

Code:

NCT06745388

Conditions

Uterine Cramps

Postoperative Pain Management

Hysteroscopy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magnesium sulfate

Ketamine

Placebo

Study Details

Brief summary:

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

Uterine Cramps

Postoperative Pain Management

Hysteroscopy

Study ID

NCT06745388

Start date

Jul 29, 2025

Status verified date

Aug, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Magnesium, IV

Intravenous magnesium 2 grams given over 20 minutes intra-operatively

experimental: Ketamine, IV

Intravenous ketamine 0.5 milligrams per kilogram dosed to ideal bodyweight, IV push intra-operatively

placebo comparator: Placebo

No administration of placebo infusion, ketamine or magnesium intra-operatively

Interventions

Magnesium sulfate

Receive intravenous magnesium intra-operatively

Ketamine

Receive IV push ketamine intra-operatively

Placebo

Receives no additional medication or infusion

Primary outcome measure

  • Cramping Pain Following Hysteroscopy (1 hr post-operative) [ Time Frame: 1 hour post-operatively ]
  • Cramping Pain Following Hysteroscopy (2 hr post-operative) [ Time Frame: 2 hours post-operatively ]
  • Cramping Pain Following Hysteroscopy (24 hour post-operative) [ Time Frame: 24 hours post-operatively ]
  • Overall Pain following hysteroscopy (1 hr post-operative) [ Time Frame: 1 hour post-operatively ]
  • Overall Pain following hysteroscopy (2 hr post-operative) [ Time Frame: 2 hours post-operatively ]
  • Overall Pain following hysteroscopy (24 hr post-operative) [ Time Frame: 24 hours post-operatively ]

Central Contacts and Locations

Locations

Corewell Health William Beaumont University Hospital

Recruiting

Royal Oak, Michigan, United States, 48073

Contacts

More Information

Sponsor

William Beaumont Hospitals

Last update posted

Aug 20, 2025

Last verified

Aug, 2025

Keywords

  • hysteroscopy
  • magnesium sulfate
  • cramping
  • ketamine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by William Beaumont Hospitals on 2025-08-20.