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

ConditionPain Management
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAlbany Medical College

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Prisoner status

Pregnant

Non-English proficient

Cannot give informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • oral ketamine

    Drug

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

  • oxycodone

    Drug

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: oral ketamineExperimental treatment 1 intervention
Group B: oxycodoneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

Usage of morphine in the following 24 hours.

Usage of morphine in the following 24 hours.

Time frame
24 hours
2

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Albany Medical College

Lead sponsor

Substance Abuse and Mental Health Services Administration (SAMHSA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: