RecruitingPhase 3NCT06161805

Esketamine as Treatment for Chronic Pain Due to Endometriosis: a RCT Study


Sponsor

Reinier de Graaf Groep

Enrollment

56 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this randomized controlled trial is to investigate the effect of esketamine versus placebo on the NRS score for chronic pelvic pain. Secondary endpoints are to assess pain scores, side-effects, quality of life, depressive symptoms and pain coping.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Esketamine hydrochloride and a drug called Placebo for people with chronic pelvic pain syndrome and endometriosis. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEsketamine hydrochloride

Esketamine dosing regimen is set at 0.1 mg/kg/h as starting dosage. Dosage will be gradually increased based on heart rate, oxygen saturation, blood pressure and side effects (e.g. nausea and dissociative effects) during a period of 8 hours to a maximum of 0.5 mg/kg/h (in steps of 0.1-0.3-0.5 mg/kg/hour). This dosage regimen is similar to that used earlier by Sigtermans et al. \[1\].

DRUGPlacebo

8 hour infusion with saline (NaCl 0.9%)


Locations(1)

Nederlandse Endometriose Kliniek, Reinier de Graaf Gasthuis

Delft, Netherlands

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NCT06161805


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