Magnesium and Cramping

August 15, 2025 updated by: Roy Soto, MD, William Beaumont Hospitals

Evaluating the Impacts of Intravenous Magnesium Sulfate and Ketamine on Cramping Pain and Total Opioid Consumption Following Hysteroscopy: A Prospective, Randomized 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 initially contact via phone call 1 week prior to the procedure. If interested in participating, the study will be discussed pre-operatively and consent will be obtained. Baseline data including demographics, gynecological medical and surgical history, social history, allergies, current medications, ASA status, diagnosis, treatment and paucity will be collected.

The participant will be randomized to one of three study arms: IV magnesium, IV push ketamine, or placebo. The participants and evaluators will be blinded to the assigned study arm. The Principal Investigator and Anesthesiologist will not be blinded. All participants will receive standard of care anesthesia care and standard of care for the procedure.

Post-procedure, participants will receive standard of care pain management. Opioid consumption documented in the EMR will be recorded, and pain post-procedure pain will be assessed. Overall pain and cramping pain will be assessed using the Visual Analog Scale (VAS) at 1 hour, 2 hours, and 24 hours post procedure. The 24 hour pain assessment will be completed via phone.

Adverse events will be monitored for 24 hours post operatively.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium, IV
Intravenous magnesium 2 grams given over 20 minutes intra-operatively
Drug: Magnesium sulfate
Receive intravenous magnesium intra-operatively
Experimental: Ketamine, IV
Intravenous ketamine 0.5 milligrams per kilogram dosed to ideal bodyweight, IV push intra-operatively
Drug: Ketamine
Receive IV push ketamine intra-operatively
Placebo Comparator: Placebo
No administration of placebo infusion, ketamine or magnesium intra-operatively
Drug: Placebo
Receives no additional medication or infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cramping Pain Following Hysteroscopy (1 hr post-operative)
Time Frame: 1 hour post-operatively
Pain will be assessed 1 hour post-operatively using a Visual Analog Score (VAS). Pain is reported on a scale from 0-10; where 0=no cramping, and 10=cramping as bad as can be. A lower score indicates a better outcome.
1 hour post-operatively
Cramping Pain Following Hysteroscopy (2 hr post-operative)
Time Frame: 2 hours post-operatively
Pain will be assessed 2 hours post-operatively using a Visual Analog Score (VAS). Pain is reported on a scale from 0-10; where 0=no cramping, and 10=cramping as bad as can be. A lower score indicates a better outcome.
2 hours post-operatively
Cramping Pain Following Hysteroscopy (24 hour post-operative)
Time Frame: 24 hours post-operatively
Pain will be assessed 24 hours post-operatively using a Visual Analog Score (VAS). Pain is reported using a scale from 0-10; where 0=no cramping, and10=cramping as bad as can be. A lower score indicates a better outcome.
24 hours post-operatively
Overall Pain following hysteroscopy (1 hr post-operative)
Time Frame: 1 hour post-operatively
Overall pain will be assessed 1 hour post-operatively using a 100-point Visual Analog Score (VAS). Pain is reported on a scale from 0-100; where 0=no pain, and 100=pain as bad as can be. A lower score indicates a better outcome.
1 hour post-operatively
Overall Pain following hysteroscopy (2 hr post-operative)
Time Frame: 2 hours post-operatively
Overall pain will be assessed 2 hours post-operatively using a 100-point Visual Analog Score (VAS). Pain is reported on a scale from 0-100; where 0=no pain, and 100=pain as bad as can be. A lower score indicates a better outcome.
2 hours post-operatively
Overall Pain following hysteroscopy (24 hr post-operative)
Time Frame: 24 hours post-operatively
Overall pain will be assessed 24 hours post-operatively using a 100-point Visual Analog Score (VAS). Pain is reported on a scale from 0-100; where 0=no pain, and 100=pain as bad as can be. A lower score indicates a better outcome.
24 hours post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption Following Hysteroscopy
Time Frame: 24 hours post-operatively
Opioid consumption will be recorded in morphine milligram equivalents (MME). The total MME for all patients for each intervention arm. A lower number indicates a better outcome as fewer opioids were consumed for pain management post-procedure.
24 hours post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Beaumont Hospitals

Investigators

  • Principal Investigator: Ray Soto, MD, William Beaumont Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

December 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 20, 2025

Last Update Submitted That Met QC Criteria

August 15, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual patient data (IPD) may be made available on request to the principal investigator.

IPD Sharing Time Frame

Available following final closure of study and publication of results (anticipated December 2026) for up to 2 years (anticipated December 2028).

IPD Sharing Access Criteria

Deidentified data may be made available on request to the principal investigator for legitimate research use.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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