Outcomes Registry After Ketamine Infusions for Chronic Pain: A Longitudinal Evaluation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorStanford University
About this trial
Ketamine is an anesthetic drug that is sometimes used to relieve chronic pain. The goal of this observational study is to learn about how patients respond to ketamine infusions for chronic pain.
Note: This study does not provide ketamine - instead, this study uses surveys to follow patients who are already scheduled to receive ketamine infusions as part of their regular medical care.
We will also follow a second group of patients who were recommended ketamine infusions by their doctor but were denied insurance coverage for this treatment. These participants will complete the same surveys for up to 16 weeks, starting from when their treatment was originally scheduled. Comparing this group to patients who received ketamine will help researchers better understand ketamine's effects and how insurance denials affect chronic pain patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Planning to receive an intravenous ketamine infusion for the treatment of chronic pain
Disqualifiers
Unable to read or understand English questionnaires
Trial population
Adults who have had a treating physician order ketamine infusion therapy for the treatment of chronic pain
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ketamine (Ketalar)
DrugIntravenous ketamine infusion delivered as part of routine clinical care
Treatment groups
800 Participants
are divided into 2 treatment groupsGroup A: Ketamine Treated Cohort1 intervention
Group B: Denied Treatment Cohort0 interventions
Trial outcomes
Primary outcomes
1
Change in PROMIS Pain Interference Score From Baseline
Time frame
8, 10, and 12 weeks after the ketamine infusionSecondary outcomes
1
Change in Opioid Use From Baseline, Patient-Rated Global Assessment
Time frame
From enrollment to 12 weeks after the ketamine infusionOther outcomes
1
Change in Pain Intensity From Baseline, 0-10 Numeric Rating Scale
Time frame
From enrollment to 16 weeks after the ketamine infusion2
Change in PROMIS Physical Function Score From Baseline
Time frame
From enrollment to 16 weeks after the ketamine infusion3
Change in PROMIS Sleep Disturbance Score From Baseline
Time frame
From enrollment to 16 weeks after the ketamine infusion4
Change in PROMIS Anxiety Score From Baseline
Time frame
From enrollment to 16 weeks after the ketamine infusionSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: