Uterine CrampsPhase 4NCT06745388
Magnesium and Cramping
A Phase 4 study testing Magnesium sulfate and Ketamine in people with Uterine Cramps and Postoperative Pain Management, run by Corewell Health East at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cramps, Postoperative Pain Management, Hysteroscopy
- What is being tested?
- Magnesium sulfate and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2025to Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
Ray Soto, MD, 248-898-0833, roy.soto@corewellhealth.org
Pamela Sloan, RN, BSN, 248-551-6059, pamela.sloan@corewellhealth.org
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Uterine Cramps, Postoperative Pain Management, Hysteroscopy
- Being tested
- Magnesium sulfate, Ketamine, Placebo
- Keywords
- hysteroscopy, magnesium sulfate, cramping, ketamine
- Medical subject headings
- Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
Receive intravenous magnesium intra-operatively
KetamineDrug
Receive IV push ketamine intra-operatively
PlaceboDrug
Receives no additional medication or infusion
| Study group | Role | What they receive |
|---|---|---|
| Magnesium, IV | Experimental | Intravenous magnesium 2 grams given over 20 minutes intra-operatively Receives: Drug: Magnesium sulfate |
| Ketamine, IV | Experimental | Intravenous ketamine 0.5 milligrams per kilogram dosed to ideal bodyweight, IV push intra-operatively Receives: Drug: Ketamine |
| Placebo | Placebo comparator | No administration of placebo infusion, ketamine or magnesium intra-operatively Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours post-operatively
Secondary outcomes (1)
Opioid consumption Following Hysteroscopy
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.
Measured: 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start29 Jul 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine CrampsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roy Soto, MD, Corewell Health East
- Investigators
- Ray Soto, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745388
- Sponsor's protocol ID
- 2024-115
- Status last verified
- Aug 2025
- First submitted
- 17 Dec 2024
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual patient data (IPD) may be made available on request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impacts of Intravenous Magnesium Sulfate and Ketamine on Cramping Pain and Total Opioid Consumption Following Hysteroscopy: A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT06745388
- Acronym / sponsor ID
- 2024-115
- Conditions
- Uterine Cramps, Postoperative Pain Management, Hysteroscopy
- Keywords
- hysteroscopy, magnesium sulfate, cramping, ketamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Magnesium, IV | Experimental | Drug: Magnesium sulfateIntravenous magnesium 2 grams given over 20 minutes intra-operatively |
| Ketamine, IV | Experimental | Drug: KetamineIntravenous ketamine 0.5 milligrams per kilogram dosed to ideal bodyweight, IV push intra-operatively |
| Placebo | Placebo comparator | Drug: PlaceboNo administration of placebo infusion, ketamine or magnesium intra-operatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulfateReceive intravenous magnesium intra-operatively | Drug | Magnesium, IV |
| KetamineReceive IV push ketamine intra-operatively | Drug | Ketamine, IV |
| PlaceboReceives no additional medication or infusion | Drug | Placebo |
Primary outcome
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.
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.
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.
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.
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.
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.
1 secondary outcome
Opioid consumption Following Hysteroscopy
Time frame: 24 hours post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual patient data (IPD) may be made available on request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ray Soto, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium sulfate and Ketamine in people with Uterine Cramps and Postoperative Pain Management, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ray Soto, MD (248-898-0833, roy.soto@corewellhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cramping Pain Following Hysteroscopy (1 hr post-operative) (time frame: 1 hour post-operatively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.