Sub-Dissociative Ketamine and Fentanyl to Treat Moderate to Severe Pain
NCT03959852 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2020-09-11
Summary
The objective of this study is to evaluate the potential opioid-sparing effect associated with the novel combination of fentanyl and sub-dissociative ketamine in adult patients with moderate to severe pain in the emergency department.
Conditions
- Pain, Acute
Interventions
- DRUG
-
1 mg/kg of Fentanyl IV administered over at least 1 minute
- COMBINATION_PRODUCT
-
Fentanyl and Ketamine
Combined dose of 0.15 mg/kg of Sub-dissociative Ketamine and 0.5 mg/kg of Fentanyl IV administered over at least 1 minute.
- DRUG
-
0.3 mg/kg of Sub-Dissociative Ketamine IV administered over at least 1 minute
Sponsors & Collaborators
-
Mercy Health Ohio
lead OTHER
Principal Investigators
-
David Gemmel · Director of Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-11-18
- Primary Completion
- 2020-06-05
- Completion
- 2020-06-05
- FDA Drug
- Yes
Countries
- United States
Study Locations
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