Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

22 de junio de 2026 actualizado por: Michael Waxman, Albany Medical College

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

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • Fase 2
  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • New York
      • Albany, New York, Estados Unidos, 12208
        • Albany Medical Center Emergency Department
        • Contacto:
          • Michael Waxman, MD
          • Número de teléfono: 518-262-3443
          • Correo electrónico: waxmanm@amc.edu
        • Contacto:
          • Andrew Chang, MD, MS
          • Número de teléfono: 518-262-3443
          • Correo electrónico: changa1@amc.edu
        • Investigador principal:
          • Michael Waxman, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: oral ketamine
The oral ketamine arm will receive a dose of oral ketamine as a second line pain medication.
A dose of oral ketamine administered as a second line pain management medicine in the emergency department.
Comparador activo: oxycodone
The oxycodone arm will receive a dose of oxycodone as a second line pain medication.
A dose of oxycodone administered as a second line pain management medicine in the emergency department.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in mean pain score
Periodo de tiempo: 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.
This will be assessed at 30 minutes and 60 minutes after receiving the study drugs.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Usage of morphine in the following 24 hours.
Periodo de tiempo: 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.
Periodo de tiempo: 1 month and 3 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

24 de junio de 2026

Finalización primaria (Estimado)

31 de diciembre de 2026

Finalización del estudio (Estimado)

30 de abril de 2027

Fechas de registro del estudio

Enviado por primera vez

22 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de junio de 2026

Publicado por primera vez (Actual)

26 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir