Dexmedetomidine for Refractory Pain in Palliative Cancer Patients

NCT07885475 — Recruiting, 30 participants, St. Olavs Hospital

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07885475, acronym DEX-PAL
Status	Recruiting
Study type	Observational
Enrollment	30 (Estimated)
Sponsor	St. Olavs Hospital (Other); collaborators: Alesund Hospital, Drammen sykehus, Oslo University Hospital, Universitetssykehuset i Nord-Norge HF
Conditions	Cancer, Palliative Care, Patient Care, Pain Management, Dexmedetomidine Analgesia, Opioid
Dates	start 2026-04-10, primary completion 2027-10-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-10-21, last updated 2026-10-21
Locations	4 sites in Norway

-Summary

The goal of this study is to find out whether the medication dexmedetomidine can be a safe and effective additional treatment for cancer patients whose pain is not well controlled by standard pain medicines (such as opioids).

The study includes 30 palliative care patients who still have significant pain despite standard pain treatment. All participants will receive dexmedetomidine, and outcomes related to efficacy and safety will be systematically observed.

Expand all sections · Collapse all

+Detailed description

The overall aim of this study is to investigate whether add-on dexmedetomidine, a selective alpha-2 adrenergic receptor agonist, is effective and safe in the treatment of refractory cancer pain. The study is designed as a prospective observational study, including 30 palliative cancer patients with uncontrolled cancer pain despite the use of opioids, about to undergo treatment with dexmedetomidine.

Dexmedetomidine is used in intensive care units as a sedative, anxiolytic, and analgesic-sparing drug. It represents a promising treatment option in advanced cancer patients with uncontrolled pain. Off-label use of dexmedetomidine for refractory cancer pain is conducted in Norwegian hospitals. However, the evidence base for the use of dexmedetomidine in this population is limited. Available studies are mostly small and retrospective, with a high risk of bias. To assure patient safety and to establish a better body of evidence, a prospective observational trial on the use of dexmedetomidine in palliative cancer care is needed.

+Outcome measures

Primary outcomes

Pain intensity [5 days]: Change in worst pain intensity past 24 hours (NRS 0-10) on day five.

Secondary outcomes

Dexmedetomidine dose [Baseline starting dose, dose day 5, dose alterations during the follow-up period as long at treated with dexmedetomidine. Maximum 6 months.]: Dexmedetomidine dose at start, day 5 and during follow-up.
Adverse events [Through study completion, as long as treated with dexmedetomidine Maximum 6 months.]: Adverse events (AE) registrations during the study period.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Adult cancer patients (>18 years), not receiving curative treatment
* Treated with parenteral opioids for cancer-related pain
* Indication to start dexmedetomidine treatment due to uncontrolled background pain (NRS > 4 in a numeric rating scale (NRS 0-10)) despite hospitalization and standard pain management.

Exclusion Criteria:

* Dexmedetomidine hypersensitivity
* Hypotension (systolic blood pressure (BP) < 90)
* Bradycardia (heart rate (HR) < 50)
* Serious heart disease or AV block grade 2 or 3 if no pacemaker.
* Severe liver failure (e.g. Child-Pugh-C or similar)
* Acute cerebrovascular disease
* Neuraxial pain management
* Patients unable to comply with trial procedures

+Locations (4)

Facility	City	Country	Status
Drammen Hospital	Drammen	Norway	Not yet recruiting
Oslo University Hospital	Oslo	Norway	Not yet recruiting
Univsersity Hospital of North Norway	Tromsø	Norway	Not yet recruiting
St.Olavs Hospital, Trondheim Univsersity Hospital	Trondheim	Norway	Recruiting