TerminatedPhase 4ketamine

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

NCT ID

NCT03959852

Target Enrollment

6 participants

Start Date

2019-11-18

Est. Completion

2020-06-05

About This Study

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 Studied

Pain, Acute

Interventions

•Fentanyl
•Fentanyl and Ketamine
•Ketamine

Eligibility

Age:18 Years - 65 Years

Healthy Volunteers:Yes

View full eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Study Locations (1)

St. Elizabeth Boardman Hospital

Boardman, Ohio, United States