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

NCT07670507 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 7471
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pain Management

Keywords

oral ketamine; pain control; oxycodone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

  1 month and 3 months after study enrollment.

Study Arms (2)

oral ketamine

EXPERIMENTAL

The oral ketamine arm will receive a dose of oral ketamine as a second line pain medication.

Drug: oral ketamine

oxycodone

ACTIVE COMPARATOR

The oxycodone arm will receive a dose of oxycodone as a second line pain medication.

Drug: oxycodone

Interventions

oxycodone DRUG

A dose of oxycodone administered as a second line pain management medicine in the emergency department.

oxycodone

oral ketamine DRUG

A dose of oral ketamine administered as a second line pain management medicine in the emergency department.

oral ketamine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Albany Medical College: lead
• Substance Abuse and Mental Health Services Administration (SAMHSA): collaborator

Study Sites (1)

Albany Medical Center Emergency Department

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine; Oxycodone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Research Director, Department of Emergency

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: June 24, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)