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RECRUITING
NCT06161805
PHASE3

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

Sponsor: Reinier de Graaf Groep

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2024-03-01

Completion Date

2026-06-01

Last Updated

2025-04-11

Healthy Volunteers

No

Interventions

DRUG

Esketamine 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. \[1\].

DRUG

Placebo

8 hour infusion with saline (NaCl 0.9%)

Locations (1)

Nederlandse Endometriose Kliniek, Reinier de Graaf Gasthuis

Delft, Netherlands