Pregabalin plus dexmedetomidine for reducing pain and improving sleep in fibromyalgia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults meeting the 2016 fibromyalgia diagnostic criteria with a baseline pain NRS ≥4 are enrolled and receive either pregabalin alone or pregabalin combined with dexmedetomidine. The trial compares pain relief rates, sleep quality, and adverse events between the two intervention groups during the treatment period. Participants must have acceptable liver and kidney function and cannot have epilepsy, depression requiring antidepressants, pregnancy, or serious uncontrolled systemic disease. Investigators hypothesize the combination will provide greater pain relief and better sleep without a substantial increase in side effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;
* Aged 18 years or older;
* Experiencing moderate to severe FM that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM;
* Numeric rating scale (NRS) score ≥ 4 at baseline;
* Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
* Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
* Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.

Exclusion criteria

* History of hypersensitivity to pregabalin, venlafaxine or any of its excipients;
* History of epilepsy, or depression requiring antidepressant medications;
* Pregnancy or breastfeeding;
* Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac dysfunction;
* With acute or chronic pain conditions other than FM.

Where it's running

• Beijing Tiantan Hospital, Beijing, Beijing 100070
  Beijing, China Recruiting

Study contacts

• Study coordinator: Fang Luo
• Email: 13611326978@163.com
• Phone: +8613611326978

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Pregabalin versus crisugabalin for fibromyalgia pain

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• Pregabalin plus venlafaxine for fibromyalgia pain

  This trial tests whether adding venlafaxine to pregabalin gives better pain relief for adults with moderate-to-severe fibromyalgia than pregabalin alone.

  Recruiting at 2 sites Beijing Tiantan Hospital · Beijin and 1 other locations · NCT07186751

• Pregabalin plus desvenlafaxine for fibromyalgia pain

  This test will try whether adding desvenlafaxine to pregabalin gives better pain relief for adults with moderate to severe fibromyalgia.

  Recruiting Beijing Tiantan Hospital · Beijing · NCT07171320

• Comparing pregabalin and mirogabalin for fibromyalgia pain

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• Treating delirium after coronary bypass with pregabalin versus dexmedetomidine

  This study will test whether pregabalin or dexmedetomidine works better to treat delirium in patients aged 65 and older after coronary artery bypass grafting.

  Recruiting Phase 4 Tanta University · Tanta, El-Gharbia Governorate · NCT05640453

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.