Sub-Dissociative Ketamine and Fentanyl to Treat Moderate to Severe Pain

Stopped early · Phase 4

Conditions studied: Pain, Acute

In brief

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.

Key facts

Study ID

NCT03959852

Run by

Mercy Health Ohio

People needed

6

Starts

2019-11-18

Expected to finish

2020-06-05

Last updated by the study team

2020-09-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 - 65 years old
• Moderate pain defined as 4-6 out of 10, severe pain defined as ≥ 7 out of 10 as defined by the numeric rating pain scale (NRS)
• Proficient in reading and understanding English
• Are deemed by the attending physician to require opioid therapy.

You may not qualify if…

• Inability to give consent,
• Inability to use the numeric rating scale (NRS) score
• Long-term use of opioids, history of chronic pain
• Known substance abuse known as excessive use of a drug such as (e.g. alcohol, narcotics or cocaine)
• Known hypersensitivity to ketamine or fentanyl
• Pregnancy
• Alcohol intoxication
• Depression
• Anxiety
• Chronic obstructive pulmonary disease
• Asthma
• Cirrhosis
• On dialysis
• Acute ischemic stroke
• Heart rate (HR) less < 60 bpm or > 120 bpm
• Systolic blood pressure (SBP) < 90 mmHg or > 180 mmHg
• Ischemic heart disease
• Ketamine prior to arrival
• Trauma patients
• Sepsis or septic shock
• Weight > 100 kg.

Where it is running

• St. Elizabeth Boardman Hospital — Boardman, Ohio, United States

Full record on ClinicalTrials.gov

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