Efficacy and Safety of Adjunctive Therapy Using Single High-Dose S-Ketamine Infusion for Fibromyalgia: A Multicenter,...

Area of Science:

• Pharmacology
• Neurology
• Pain Management

Background:

• Fibromyalgia (FM) presents chronic pain with limited treatment efficacy.
• Current FM treatments offer delayed relief and suboptimal responses.
• Esketamine (ESK) shows promise for rapid analgesia in FM, but higher doses as adjunct therapy need investigation.

Purpose of the Study:

• To evaluate the efficacy of higher-dose esketamine (ESK) as an adjunct to guideline-recommended pharmacotherapy for fibromyalgia (FM).
• To assess the impact of ESK on pain intensity and patient-reported outcomes in FM patients.
• To explore the safety and tolerability of ESK in combination with standard FM medications.

Main Methods:

• A multicenter, prospective, randomized, controlled trial involving 92 adult FM patients.
• Participants randomized to receive either intravenous ESK plus oral pregabalin/venlafaxine or oral pregabalin/venlafaxine alone.
• Primary outcome: change in mean pain intensity during the first week post-treatment; secondary outcomes include pain reduction, patient-reported outcomes, and safety assessments over 12 weeks.

Main Results:

• This section is to be filled once the study is completed and results are available.
• The study is designed to measure changes in pain intensity as the primary outcome.
• Secondary outcomes will provide comprehensive data on treatment effectiveness and patient well-being.

Conclusions:

• This section is to be filled once the study is completed and conclusions are drawn.
• The findings will clarify the role of higher-dose esketamine in managing fibromyalgia pain.
• Results will inform clinical practice regarding adjunctive esketamine therapy for chronic pain conditions.