Phase 3
Completed N=106
Subdissociative Dose Ketamine for Treatment of Acute Pain in Subjects With Chronic Pain
Source: ClinicalTrials.gov NCT02920528 ↗Enrolled (actual)
106
Serious AEs
27.8%
Results posted
Apr 2021
Primary outcomePrimary: To Compare the Percentage of Subjects Who Achieved Significant Pain Relief Between the 3 Treatment Groups as Measured by a Visual Analog Pain Scale at 60 Minutes A Decrease of at Least 20 mm on the VAS Will be Considered "Significant" Pain Relief — 13; 28; 25 Participants
◆ Published Evidence
Emerging
13citations · ~2 / year
Subdissociative-dose Ketamine Is Effective for Treating Acute Exacerbations of Chronic Pain.
Summary
This is a prospective, randomized controlled trial which will be conducted to determine whether sub-dissociative dose ketamine (SDDK) can improve pain control in subjects with chronic pain syndrome presenting to the emergency department with exacerbation of their chronic pain. The investigators also aim to determine whether use of SDDK can reduce the amount of subsequent opioid pain medications required for adequate pain relief in this population.
Linked Publications
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Subdissociative-dose Ketamine Is Effective for Treating Acute Exacerbations of Chronic Pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Compare the Percentage of Subjects Who Achieved Significant Pain Relief Between the 3 Treatment Groups as Measured by a Visual Analog Pain Scale at 60 Minutes A Decrease of at Least 20 mm on the VAS Will be Considered "Significant" Pain Relief |
13; 28; 25 | — |
| SECONDARY Assess the Risk for Adverse Events Associated With Sub-dissociative Dose Ketamine |
1; 14; 12 | — |
Eligibility Criteria
Inclusion Criteria
- All adult subjects over the age of 18 with chronic pain* presenting to the emergency department with exacerbation of their chronic pain as their primary complaint
- Subjects who are willing and able to provide informed consent. *Chronic pain defined as greater > 3 months of symptoms and an initial VAS pain score > 70
Exclusion Criteria
- History of overt psychosis, severe hypertension as defined by Systolic Blood Pressure > 180 mm Hg or Diastolic Blood Pressure >110 mm Hg, unstable angina, Coronary Artery Disease, Congestive Heart Failure, porphyrias, thyroid disease, seizure disorder, inability to provide informed consent: dementia, non-English/Spanish speakers, subjects in custody, suicidal, or clinically intoxicated.
Data sourced from ClinicalTrials.gov (NCT02920528) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.