Magnesium and Cramping

NCT06745388 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2024-115
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

hysteroscopy; magnesium sulfate; cramping; ketamine

Outcome Measures

Primary Outcomes (6)

• Cramping Pain Following Hysteroscopy (1 hr post-operative)

  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)

  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)

  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)

  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)

  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)

  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 Outcomes (1)

• Opioid consumption Following Hysteroscopy

  24 hours post-operatively

Study Arms (3)

Magnesium, IV

EXPERIMENTAL

Intravenous magnesium 2 grams given over 20 minutes intra-operatively

Drug: Magnesium sulfate

Ketamine, IV

EXPERIMENTAL

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

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Magnesium sulfate DRUG

Receive intravenous magnesium intra-operatively

Magnesium, IV

Ketamine DRUG

Receive IV push ketamine intra-operatively

Ketamine, IV

Placebo DRUG

Receives no additional medication or infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

RECRUITING

MeSH Terms

Conditions

Spasm

Interventions

Magnesium Sulfate; Ketamine

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ray Soto, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ray Soto, MD

CONTACT

248-898-0833; roy.soto@corewellhealth.org

Pamela Sloan, RN, BSN

CONTACT

248-551-6059; pamela.sloan@corewellhealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff physician

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: July 29, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Available following final closure of study and publication of results (anticipated December 2026) for up to 2 years (anticipated December 2028).
• Access Criteria: Deidentified data may be made available on request to the principal investigator for legitimate research use.

Locations

US (1)