150 Participants Needed

Magnesium and Ketamine for Post-Operative Pain After Hysteroscopy

RS
PS
Overseen ByPamela Sloan, RN, BSN
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether magnesium or ketamine more effectively reduces pain after a hysteroscopy, a procedure to examine the uterus. Both drugs are known to alleviate pain, but their comparative effectiveness and mechanisms remain unclear. Participants will be randomly assigned to receive magnesium (magnesium sulfate), ketamine (an anesthetic), or a placebo during their procedure. The trial seeks individuals planning to undergo an elective hysteroscopy or D&C who do not regularly use pain or psychiatric medications. As a Phase 4 trial, this research involves treatments already FDA-approved and proven effective, aiming to understand how they can benefit more patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, including magnesium, pain relievers, antidepressants, anti-anxiety medications, and opioids, before participating.

What is the safety track record for these treatments?

Research has shown that magnesium sulfate can safely reduce pain after surgery. Some studies have found it lessens pain and decreases the need for strong painkillers like opioids. Incorrect use, however, can lead to side effects such as low blood pressure and muscle weakness.

Ketamine also manages pain after surgery and is usually safe and well-tolerated. It can cause side effects like memory problems and potential harm to the nervous system. Despite this, it effectively reduces pain and can even boost mood post-surgery.

Both treatments offer advantages and disadvantages but are generally considered safe for reducing pain after procedures like hysteroscopy.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using magnesium and ketamine for post-operative pain relief after hysteroscopy because they offer unique approaches compared to traditional painkillers like opioids. Unlike opioids, which carry the risk of addiction and side effects, ketamine acts on NMDA receptors in the brain to modulate pain in a completely different way, potentially providing effective relief without those risks. Magnesium, on the other hand, may enhance pain relief by blocking calcium influx in nerve cells, which can reduce pain signaling. These treatments could offer quicker and more efficient pain management, possibly with fewer side effects.

What evidence suggests that this trial's treatments could be effective for post-operative pain after hysteroscopy?

Research has shown that both magnesium and ketamine can reduce pain after surgery. In this trial, participants will receive either magnesium or ketamine in separate treatment arms. Magnesium can decrease the need for additional pain medication after surgeries like hysteroscopies by affecting pain signals in the brain and relaxing muscles, which may alleviate cramping pain. One study found that using magnesium during hysteroscopy lowered pain and reduced the amount of extra pain medication needed. Ketamine also effectively lowers pain and reduces the need for opioids after outpatient hysteroscopy procedures. It targets the same brain signals as magnesium to help manage pain. Both treatments aim to provide effective pain relief without the side effects associated with opioids.56789

Who Is on the Research Team?

RS

Ray Soto, MD

Principal Investigator

William Beaumont Hospitals

Are You a Good Fit for This Trial?

This trial is for patients undergoing elective hysteroscopy or D&C at Corewell Health William Beaumont University Hospital. Participants must be eligible for the procedure and willing to receive IV Magnesium, IV Ketamine, or a placebo as part of their pain management.

Inclusion Criteria

I am scheduled for a hysteroscopy or D&C procedure.
My health is good to moderately impaired according to ASA standards.

Exclusion Criteria

Allergies to any of the medications that will be administered
I cannot verbally express my pain due to developmental delays.
Pregnant women
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (phone call)

Pre-operative

Discussion of the study and obtaining consent, collection of baseline data

1 day
1 visit (in-person)

Treatment

Participants undergo hysteroscopy with randomized administration of IV magnesium, ketamine, or placebo

Intra-operative
1 visit (in-person)

Post-operative Monitoring

Pain and opioid consumption are monitored and recorded post-procedure

24 hours
1 visit (in-person), 1 follow-up call

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 hours
1 follow-up call

What Are the Treatments Tested in This Trial?

Interventions

  • Ketamine
  • Magnesium sulfate
Trial Overview The study aims to compare the effectiveness of IV Magnesium and IV Ketamine against a placebo in reducing uterine cramping pain and total opioid use after hysteroscopy. It's a randomized trial where participants are assigned one of these three treatments by chance.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Magnesium, IVExperimental Treatment1 Intervention
Group II: Ketamine, IVExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials
153
Recruited
113,000+

Citations

Effect of low-dose esketamine on postoperative quality ...Studies have shown that patients treated with laparoscopic gynecological surgery have an 80% chance of experiencing pain after surgery [6].
Study Details | NCT06745388 | Magnesium and CrampingPain 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.
Low-Dose Ketamine for Outpatient HysteroscopyThey had reduced pain scores and reduced opioid requirements with the use of low-dose ketamine infusion (p=0.001) (22). Ketamine in sub-anaesthetic doses has ...
Effect of different doses of esketamine on the median ...Esketamine can dose-dependently reduce the EC 50 of propofol in hysteroscopy, while concurrently lowering patients' HADS-A and HADS-D scores 24 h post- ...
Low-Dose Ketamine for Outpatient HysteroscopyThey had reduced pain scores and reduced opioid requirements with the use of low-dose ketamine infusion (p=0.001) (22). Ketamine in sub-anaesthetic doses has ...
Role of Ketamine in Acute Postoperative Pain ManagementWhile ketamine is a safe and well-tolerated drug, it does have adverse effects, and there are concerns for possible neurotoxicity and effects on memory.
Efficacy and safety of perioperative application of ketamine ...In conclusion, perioperative application of ketamine reduces postoperative depression and pain scores with increased risk of adverse effects.
Study Details | NCT07059429 | Ketamine Administration for ...This study is conducted to evaluate the effectiveness and safety of ketamine infusion for pain relief after knee replacement surgery.
Ketamine for pain managementPerioperative ketamine decreased postoperative pain scores, 4,8,16,21,30,36,42,55,60,63 increased the time to first analgesic request, 21,60 and reduced ...
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