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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04057989
Retrospective Evaluation of Ketamine Effectiveness for the Treatment of Acute Battlefield Related Pain
A Retrospective Evaluation of Ketamine Effectiveness for the Treatment of Acute Battlefield Related Pain
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a retrospective study to determine if there is a relationship between intravenous infusion of ketamine given for analgesia and the use of additional opioid pain medications and patient reported pain levels before and during ketamine usage. The investigator anticipates that records of up to 700 subjects will be reviewed for eligibility. The time period 24 hours before the initial ketamine therapy is initiated along with 24 & 48 hours after the start of ketamine therapy will be the time periods examined. The average/minimum/maximum pain scores during these time periods will be used. Medication usage will be calculated over the 24 hour time periods.
This protocol is presented as an initial step in exploring the possible relationship between the administration of ketamine as an analgesic agent, the potential reduction in pain medications, and the potential reduction of pain levels. With this the goals/objectives are as follows:
Objectives
- To compare morphine consumption in battlefield injured patients with acute pain 24 hours before the initiation of a ketamine infusion to the subsequent 48 hours following the start of infusion.
- To compare average/minimum/maximum pain scores in battlefield injured patients with acute pain 24 hours before the initiation of a ketamine infusion to the subsequent 48 hours following the start of infusion.
- To describe the pain trajectory in battlefield injured patients with acute pain after the initiation of ketamine infusions.
- To measure the absolute and proportional incidence of ketamine associated side effects in battlefield injured patients with acute pain following the initiation of ketamine infusions.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20889
- Walter Reed National Military Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Battlefield injured from January 2007 to December 2013
- Prescribed a ketamine infusion for acute pain
- Awake, alert (non intubated/sedated), and able to report pain scores 24 hours prior to the start of infusion and up to 48 hours following infusion
Exclusion Criteria:
- Patients who did not receive an injury in theater and did not receive ketamine while being treated by the APS or WRNMMC/WRAMC hospital staff
- No continuous perineural catheter or epidural placement while on ketamine infusion
- Less than 18 years old
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Battlefield Injury with ketamine treatment
Patients who received ketamine infusions to treat pain from January 2007 to December 2013.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Opioid consumption measured in morphine equivalents
Periodo de tiempo: 24 hours before ketamine infusion
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Amount of opioids consumed within time frame
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24 hours before ketamine infusion
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Opioid consumption measured in morphine equivalents
Periodo de tiempo: 24 hours after ketamine infusion
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Amount of opioids consumed within time frame
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24 hours after ketamine infusion
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Opioid consumption measured in morphine equivalents
Periodo de tiempo: 48 hours after ketamine infusion
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Amount of opioids consumed within time frame
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48 hours after ketamine infusion
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Pain scores
Periodo de tiempo: 24 hours before ketamine infusion
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Defense and Veterans Pain Rating Scale Pain scores recorded based on the Defense and Veterans Pain Rating Scale Rate the severity of your CURRENT pain: 0 - No Pain
Circle the number that describes how, during the past 24 hours, pain has interfered with your usual activity: 0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has interfered with sleep: 0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has affected your mood: 0-10 |
24 hours before ketamine infusion
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Pain scores
Periodo de tiempo: 24 hours after ketamine infusion
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Defense and Veterans Pain Rating Scale Pain scores recorded based on the Defense and Veterans Pain Rating Scale Rate the severity of your CURRENT pain: 0 - No Pain
Circle the number that describes how, during the past 24 hours, pain has interfered with your usual activity: 0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has interfered with sleep: 0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has affected your mood: 0-10 |
24 hours after ketamine infusion
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Pain scores
Periodo de tiempo: 48 hours after ketamine infusion
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Defense and Veterans Pain Rating Scale Pain scores recorded based on the Defense and Veterans Pain Rating Scale Rate the severity of your CURRENT pain: 0 - No Pain
Circle the number that describes how, during the past 24 hours, pain has interfered with your usual activity: 0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has interfered with sleep: 0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has affected your mood: 0-10 |
48 hours after ketamine infusion
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Number of ketamine side effects
Periodo de tiempo: 24 hours before ketamine infusion
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Recorded side effects after ketamine infusion
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24 hours before ketamine infusion
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Number of ketamine side effects
Periodo de tiempo: 24 after ketamine infusion
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Recorded side effects after ketamine infusion
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24 after ketamine infusion
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Number of ketamine side effects
Periodo de tiempo: 48 hours after ketamine infusion
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Recorded side effects after ketamine infusion
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48 hours after ketamine infusion
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Michael Kent, MD, Walter Reed National Military Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Dolor
- Manifestaciones neurológicas
- Heridas y Lesiones
- Trauma craneoencefálico
- Trauma, Sistema Nervioso
- Trastornos relacionados con el trauma y el estrés
- Lesiones Cerebrales
- Trastornos de Estrés, Traumáticos
- Trastornos de estrés postraumático
- Lesiones Cerebrales Traumáticas
- Dolor agudo
- Amputación Traumática
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Anestésicos, Disociativos
- Anestésicos Intravenosos
- Anestésicos Generales
- Anestésicos
- Antagonistas de aminoácidos excitatorios
- Agentes de aminoácidos excitatorios
- Ketamina
Otros números de identificación del estudio
- 399623
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. .
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