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

NCT07670507 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-26

No results posted yet for this study

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

Interventions

DRUG

oral ketamine

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

DRUG

oxycodone

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

Sponsors & Collaborators

  • Substance Abuse and Mental Health Services Administration (SAMHSA)

    collaborator FED

  • Albany Medical College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-24
Primary Completion
2026-12-31
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07670507 on ClinicalTrials.gov