TerminatedPhase 4

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

Stopped: Residency completed.

United States6 participantsStarted 2019-11-18

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Analgesia of combination fentanyl and SDK as assessed using the pain scale 1-10

Timeframe: ED encounter (less than 24 hours)

Analgesia of fentanyl as assessed using the pain scale 1-10

Timeframe: ED encounter (less than 24 hours)

Analgesia of ketamine as assessed using the pain scale 1-10

Timeframe: ED encounter (less than 24 hours)

Trial details

NCT IDNCT03959852

SponsorMercy Health Ohio

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-05

View on ClinicalTrials.gov More Pain, Acute trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Analgesia of combination fentanyl and SDK as assessed using the pain scale 1-10

Timeframe: ED encounter (less than 24 hours)

Analgesia of fentanyl as assessed using the pain scale 1-10

Timeframe: ED encounter (less than 24 hours)

Analgesia of ketamine as assessed using the pain scale 1-10

Timeframe: ED encounter (less than 24 hours)