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

• Status: Terminated
• Trial end date: 2020-06-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mercy Health Ohio
• Treatments: Fentanyl; Ketamine

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.