Pilot Randomized Control Trial Comparing Oral Ketamine and Oral Oxycodone for Pain Control in Eme… (NCT07670507) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Pilot Randomized Control Trial Comparing Oral Ketamine and Oral Oxycodone for Pain Control in Emergency Department Patients
United States60 participantsStarted 2026-06-24
Plain-language summary
The goal of this pilot randomized clinical trial is to learn if oral ketamine intervention can control pain in emergency department patients whose providers feel the need for additional pain medication. The main questions it aims to answer are:
* Does oral ketamine result in a different mean change in pain scores compared with oral oxycodone?
* Is there a difference in the need for additional opioid administration within 24 hours after the initial dose of study medication (oral ketamine vs oral oxycodone)?
Researchers will compare oral ketamine to oral oxycodone to see if there is a difference in pain control or the need for additional opioid administration.
Participants will:
* Fill out a survey prior to study medication administration assessing pain scores, pain presentation, and medication history
* Be randomized to and receive a dose of oral ketamine or oral oxycodone as the study medication for pain control
* Fill out a survey assessing pain control, side effects, and safety outcomes
* Receive follow-up phone calls at 1 and 3 months after enrollment to assess pain and opioid use
Who can participate
Age range
18 Years – 75 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:
* ED patient aged 18 years or older AND
* English proficient AND
* Able to give informed consent AND
* Has a painful condition in the ED that includes any of the following: Musculoskeletal extremity pain, Musculoskeletal back or neck pain, Other nociceptive extremity pain
* AND treating provider has deemed the patient necessitating 'second line pain therapy' (meaning: opioids or ketamine)
Exclusion Criteria:
Any of the following:
* Prisoner status
* Pregnant
* Non-English proficient
* Cannot give informed consent
* Requires emergent intravenous pain medicine (as deemed by the treating provider)
* Prior participation in the study
* Previous diagnosis of opioid use disorder
* Previous ketamine addiction
* Patient is in hospice or other palliative care measures
* Contraindication to ketamine, including: Cystitis or bladder pain, Intracranial hypertension, Known coronary artery disease, Age greater than 75 years old, History of prior adverse reaction to ketamine or oxycodone, History or current major psychiatric disorder (as deemed by the treating ED clinician) or history of psychosis
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
1
Change in mean pain score
Timeframe: This will be assessed at 30 minutes and 60 minutes after receiving the study drugs.