A Phase 2/3 interventional study of oral ketamine and oxycodone in Pain Management, sponsored by Albany Medical College. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Albany Medical College · Phase 2/3, Interventional, and Treatment
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:
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:
In an effort to combat the ongoing opioid crisis, healthcare providers continue to search for alternatives to opioids that are both safe and effective. While no medicine has an ideal profile, oral ketamine have attributes that may serve emergency department (ED) patients well when dealing with painful conditions. While IV ketamine has been well-studied in the ED setting and oral ketamine has been studied in the post-operative setting, there is limited data describing the safety and effectiveness of oral ketamine in the ED setting. Guided by colleagues from the Anesthesia Acute Pain Service, the Albany Medical Center (AMC) ED has begun giving oral ketamine to appropriate ED patients with painful conditions. We aim to conduct a pilot, un-blinded randomized controlled trial to compare the benefits and detriments of oral ketamine vs. oxycodone in ED patients who require 'second line' pain medicine.
A convenience sample of emergency department patients will be randomized to receive either:
Oxycodone arm:
o The treating provider will order oral oxycodone 5 mg times one
or
o The treating provider has made a deliberate decision that the patient requires (because of weight, prior exposures, etc.) greater than oxycodone 5mg times one
Oral ketamine arm:
o The treating provider will order ketamine 0.75 mg/kg oral times one (max 80mg)
Outcomes measured
Participants will be assessed for
We will calculate a difference in change in mean pain scores before and after the intervention in each study arm. We will also compare morphine milli-equivalents use during the time intervals above, as well as usage of opioids, ketamine, and recreational drugs during the one month and three month period after enrollment.
Because this is a pilot study, we have not calculated an effect size.
Albany Medical College is the lead sponsor of 81 studies on the registry; 14 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The oral ketamine arm will receive a dose of oral ketamine as a second line pain medication.
Drug: oral ketamine
The oxycodone arm will receive a dose of oxycodone as a second line pain medication.
Drug: oxycodone
A dose of oral ketamine administered as a second line pain management medicine in the emergency department.
A dose of oxycodone administered as a second line pain management medicine in the emergency department.
Change in mean pain score
This reflects the mean difference between the pain scores before and after the intervention.
Time frame: This will be assessed at 30 minutes and 60 minutes after receiving the study drugs.
Usage of morphine in the following 24 hours.
Usage of morphine in the following 24 hours.
Time frame: 24 hours
Usage of opioids, ketamine, or recreational drugs one month and three months after study enrollment.
Usage of opioids, ketamine, or recreational drugs one month and three months after study enrollment.
Time frame: 1 month and 3 months after study enrollment.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Dec 2026, 6 months later.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ketamine
Agnosia
Albany Medical College