Pain ManagementPhase 2/3PKORCTNCT07670507
Pilot Randomized Control Trial Comparing Oral Ketamine and Oral Oxycodone for Pain Control in Emergency Department Patients
A Phase 2/3 study testing oral ketamine and oxycodone in people with Pain Management, run by Albany Medical College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain Management
- What is being tested?
- oral ketamine and oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2026to 30 Apr 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Albany Medical Center Emergency Department
Albany, New York, 12208
Michael Waxman, MD, 518-262-3443, waxmanm@amc.edu
Andrew Chang, MD, MS, 518-262-3443, changa1@amc.edu
About this study
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)?
Read more
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
Read the detailed description
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:
- The treating provider will order oral oxycodone 5 mg times one or
- 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:
- The treating provider will order ketamine 0.75 mg/kg oral times one (max 80mg)
Outcomes measured
Participants will be assessed for
- Pain scores at 30 and 60 minutes after either study drug administration
- Whether they received opioids at 6 hours, 12 hours, and 24 hours after receiving either study drug
- For admitted patients, whether they received opioids upon admission to the hospital, and whether they were discharged with a prescription for opioids
- Whether the participation has received opioid pain medicines, ketamine, or other recreational drugs during the one month after enrolling in the study
- Whether the participation has received opioid pain medicines, ketamine, or other recreational drugs during the three months after enrolling in the study
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.
- Conditions
- Pain Management
- Being tested
- oral ketamine, oxycodone
- Keywords
- oral ketamine, pain control, oxycodone
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral ketamineDrug
A dose of oral ketamine administered as a second line pain management medicine in the emergency department.
oxycodoneDrug
A dose of oxycodone administered as a second line pain management medicine in the emergency department.
| Study group | Role | What they receive |
|---|---|---|
| oral ketamine | Experimental | The oral ketamine arm will receive a dose of oral ketamine as a second line pain medication. Receives: Drug: oral ketamine |
| oxycodone | Active comparator | The oxycodone arm will receive a dose of oxycodone as a second line pain medication. Receives: Drug: oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean pain score
This reflects the mean difference between the pain scores before and after the intervention.
Measured: This will be assessed at 30 minutes and 60 minutes after receiving the study drugs.
Secondary outcomes (2)
Usage of morphine in the following 24 hours.
Usage of morphine in the following 24 hours.
Measured: 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.
Measured: 1 month and 3 months after study enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start24 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Responsible party
- Principal investigator, Michael Waxman, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670507
- Sponsor's protocol ID
- 7471
- Acronym
- PKORCT
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Control Trial Comparing Oral Ketamine and Oral Oxycodone for Pain Control in Emergency Department Patients
- ClinicalTrials.gov ID
- NCT07670507
- Acronym / sponsor ID
- PKORCT / 7471
- Conditions
- Pain Management
- Keywords
- oral ketamine, pain control, oxycodone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Study start
- 24 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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:
- The treating provider will order oral oxycodone 5 mg times one or
- 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:
- The treating provider will order ketamine 0.75 mg/kg oral times one (max 80mg)
Outcomes measured
Participants will be assessed for
- Pain scores at 30 and 60 minutes after either study drug administration
- Whether they received opioids at 6 hours, 12 hours, and 24 hours after receiving either study drug
- For admitted patients, whether they received opioids upon admission to the hospital, and whether they were discharged with a prescription for opioids
- Whether the participation has received opioid pain medicines, ketamine, or other recreational drugs during the one month after enrolling in the study
- Whether the participation has received opioid pain medicines, ketamine, or other recreational drugs during the three months after enrolling in the study
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral ketamine | Experimental | Drug: oral ketamineThe oral ketamine arm will receive a dose of oral ketamine as a second line pain medication. |
| oxycodone | Active comparator | Drug: oxycodoneThe oxycodone arm will receive a dose of oxycodone as a second line pain medication. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- Prisoner status
- Pregnant
- Non-English proficient
- Cannot give informed consent
- Requires emergent intravenous pain medicine (as deemed by the treating provider)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral ketamineA dose of oral ketamine administered as a second line pain management medicine in the emergency department. | Drug | oral ketamine |
| oxycodoneA dose of oxycodone administered as a second line pain management medicine in the emergency department. | Drug | oxycodone |
Primary outcome
Change in mean pain score
Time frame: This will be assessed at 30 minutes and 60 minutes after receiving the study drugs.
This reflects the mean difference between the pain scores before and after the intervention.
2 secondary outcomes
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.
Time frame: 1 month and 3 months after study enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing oral ketamine and oxycodone in people with Pain Management, run by Albany Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean pain score (time frame: This will be assessed at 30 minutes and 60 minutes after receiving the study drugs.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.