Ketamine produces effective and long-term pain relief in patients with Complex Regional Pain Syndrome Type 1.
Marnix J Sigtermans, Jacobus J van Hilten, Martin C R Bauer...
https://pubmed.ncbi.nlm.nih.gov/19604642Actively Recruiting
Phase 3
Age: 18Years - 50Years
FEMALE
ID06161805
Esketamine as Treatment for Chronic Pain Due to Endometriosis: a Randomized Controlled Trial
Led by Reinier de Graaf Groep · Updated on 2025-04-11
56
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates chronic pelvic pain caused by endometriosis, a chronic inflammatory condition affecting about 10% of women of reproductive age. This disease often leads to severe pain, reduced quality of life, depression, and economic impact. The study aims to assess how esketamine, a drug with pain-relieving, anti-inflammatory, and antidepressant properties, compares to placebo in treating this chronic pain through a randomized controlled design. Participants will receive either an esketamine infusion or a placebo saline infusion. The esketamine dosing begins at 0.1 mg/kg/h and may be increased gradually every few hours over an 8-hour period up to a maximum of 0.5 mg/kg/h based on monitored vital signs and side effects. The placebo group will receive an 8-hour saline infusion. This treatment phase is followed by scheduled assessments to evaluate the effects. Participants will be monitored for pain levels, side effects, quality of life, depressive symptoms, and pain coping ability before and after treatment. Assessments occur at baseline and at multiple time points up to 12 weeks after infusion, including evaluations of pelvic pain, menstrual pain, urinary and bowel pain, depressive symptoms, and overall quality of life. Safety and treatment experiences are also recorded during and immediately after infusion. The total study duration includes follow-up visits to track ongoing effects and costs related to productivity and medical care.
CONDITIONS
Brief Title
Esketamine as Treatment for Chronic Pain Due to Endometriosis: a RCT Study
Who Can Participate
Age: 18Years - 50Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Women
- All pre-menopausal women aged above 18 years
- Diagnosed with endometriosis by ultrasound, MRI, or previous surgery according to the Enzian classification
- Endometriosis present in rectovaginal space, sacrouterine ligaments, cardinal ligaments, pelvic sidewall, rectum, intestines, diaphragm, adenomyosis, or peritoneal/superficial endometriosis
- Mild to severe chronic pelvic pain with a numeric rating scale (NRS) score of 6 or higher
- Resistant to analgesics like paracetamol and NSAIDs
- Not currently using strong opioids or discontinued them more than 1 week ago
- Indication for or on waiting list for endometriosis surgery
- Able to understand patient information and provide informed consent
- No change in hormonal therapy within 1 month prior to inclusion
You will not qualify if you...
- Pain score below 6 out of 10 on the NRS for chronic pelvic pain
- Endometriosis affecting the bladder and ureter
- Increased intracranial pressure
- Poorly controlled hypertension over 180/100 mmHg at rest
- Thyroid disease
- Cancer
- History of psychiatric illness such as schizophrenia, psychosis, delirium, or manic depression
- Serious medical diseases including cardiovascular, renal, pulmonary, or liver disease
- Severe liver disease
- Glaucoma
- Use of strong opioid medication
- Use of xanthine derivatives or ergometrine
- Unstable angina, heart failure, or previous stroke
- Active infection
- Epilepsy
- Trying to become pregnant or currently breastfeeding
- Unable to complete questionnaires in Dutch
- Mentally incompetent as evaluated by physician
- Alcohol or drug abuse
- Known allergy to (es)ketamine
- Abnormal liver enzyme levels at baseline (ASAT, ALAT, GGT, AF, Bilirubin total)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 hours
Participants receive an 8-hour infusion of either esketamine or placebo to treat chronic pain due to endometriosis.
1 infusion visit (in-person)
Follow-up
Duration - 12 weeks
Participants are monitored for up to 12 weeks after the infusion to assess pain levels, symptoms, quality of life, and treatment effects.
Visits at baseline, and at weeks 4, 8, and 12 after treatment
Trial Site Locations
Total: 1 location
1
Nederlandse Endometriose Kliniek, Reinier de Graaf Gasthuis
Delft, Netherlands
Actively Recruiting
Loading map...
Research Team
M
Mathijs Blikkendaal, MD, PhD
R
Rozemarijn de Koning, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here