Pilot Randomized Control Trial Comparing Oral Ketamine and Oral Oxycodone for Pain Control in Emergency Department Patients (PKORCT)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pain Management
• Intervention / Treatment: Drug: oral ketamine; Drug: oxycodone

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:

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

• 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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center Emergency Department
      • Contact: Michael Waxman, MD; Phone Number: 518-262-3443; Email: waxmanm@amc.edu
      • Contact: Andrew Chang, MD, MS; Phone Number: 518-262-3443; Email: changa1@amc.edu
      • Principal Investigator: Michael Waxman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oral ketamine; The oral ketamine arm will receive a dose of oral ketamine as a second line pain medication.	Drug: oral ketamine; A dose of oral ketamine administered as a second line pain management medicine in the emergency department.
Active Comparator: oxycodone; The oxycodone arm will receive a dose of oxycodone as a second line pain medication.	Drug: oxycodone; A dose of oxycodone administered as a second line pain management medicine in the emergency department.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean pain score	This reflects the mean difference between the pain scores before and after the intervention.	This will be assessed at 30 minutes and 60 minutes after receiving the study drugs.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usage of morphine in the following 24 hours.	Usage of morphine in the following 24 hours.	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.	1 month and 3 months after study enrollment.

Collaborators and Investigators

• Sponsor: Albany Medical College
• Collaborators: Substance Abuse and Mental Health Services Administration (SAMHSA)

Study record dates

Study Major Dates

• Study Start (Estimated): June 24, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: oxycodone; pain control; oral ketamine
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Codeine; Ketamine; Oxycodone
• Other Study ID Numbers: 7471

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes