Subdissociative Dose Ketamine for Treatment of Acute Pain in Subjects With Chronic Pain

NCT02920528 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 30612-01
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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

  The primary endpoint was clinically significant pain relief defined a priori as a decrease in the pain VAS of at least 20 mm from baseline, which was arbitrarily chosen as the minimal amount that may be important to this group of patients and was extrapolated from studies of acute pain management in the ED. Using an effect size of 20-mm change in VAS as the marker for a successful outcome and the proportion of successes by group as the analysis point, we performed a power analysis using three groups: 0.5 mg/kg ketamine, 0.25 mg/kg ketamine, and placebo and found that a sample size of 96 subjects would be required to detect a statistically significant difference among groups with a power of 90% (a = 0.05). Expecting a loss of 10% of subjects due to patient withdrawal or incomplete data, 106 subjects were recruited. Only subjects who completed the 60-minute study and had data recorded for each of the time points were included in the analysis.

  60 minutes

Secondary Outcomes (1)

• Assess the Risk for Adverse Events Associated With Sub-dissociative Dose Ketamine

  1 hour

Study Arms (3)

Placebo

PLACEBO COMPARATOR

placebo controlled arm

Drug: Placebo

very low dose ketamine

EXPERIMENTAL

0.25 mg/kg of sub-dissociative ketamine as an experimental arm

Drug: Ketamine

low dose ketamine

EXPERIMENTAL

0.50 mg/kg of sub-dissociative ketamine as an experimental arm

Drug: Ketamine

Interventions

Ketamine DRUG

sub-dissociative ketamine

Also known as: ketalar

low dose ketamine; very low dose ketamine

Placebo DRUG

Normal Saline

Also known as: Normal Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead
• United States Air Force Research Laboratory: collaborator

Study Sites (1)

Emergency Department, Harbor-UCLA Medical Center

Torrance, California, 90501, United States

Location

Related Publications (1)

• Lumanauw DD, Youn S, Horeczko T, Yadav K, Tanen DA. Subdissociative-dose Ketamine Is Effective for Treating Acute Exacerbations of Chronic Pain. Acad Emerg Med. 2019 Sep;26(9):1044-1051. doi: 10.1111/acem.13755. Epub 2019 Apr 29.

  PMID: 30901130 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: David Tanen
• Organization: Lundquist Institute

dtanen@emedharbor.edu

310-222-3624

Study Officials

• David Tanen, MD

  Los Angeles Biomedical Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Emergency Medicine

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: September 30, 2016
• Study Start: May 1, 2017
• Primary Completion: June 22, 2018
• Study Completion: September 1, 2019
• Last Updated: April 15, 2021
• Results First Posted: April 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)