- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01784991
Study of Respiratory Depression When Using a Hydromorphone Pain Protocol
6 de marzo de 2020 actualizado por: Albert Einstein Healthcare Network
"Does a 1 Plus 1 Hydromorphone Pain Protocol Have a Similar Rate of Respiratory Depression to Physician Discretion Protocol in a Geriatric Population With Moderate to Severe Pain?"
This is a study about the efficiency and safety of a 1mg+1mg hydromorphone pain management protocol for the treatment of moderate to sever pain in the Emergency Department.
Appropriate patients 60 years and older who present with a condition that causes moderate to severe pain, according to the attending physician's judgment, in which the physician would order the use of parenteral analgesia will be enrolled in one of two study arms, "1+1" versus usual care group.
1+1 patients will receive 1mg hydromorphone followed by another 1mg after 15 minutes if pain persists.
Usual care group patients will have pain treated per the discretion of the attending physician.
Respiratory status, vital signs, and pain scores will be monitor to assess the efficiency of pain control as well as the safety of pain medicine administration in terms of respiratory depression.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a study about the efficiency and safety of a 1mg+1mg hydromorphone pain management protocol for the treatment of long bone fractures in the Emergency Department.
Appropriate patients 60 years and older who present with a condition that causes moderate to severe pain, according to the attending physician's judgment, in which the physician would order the use of parenteral analgesia will be screened and randomized to one of two study arms, "1+1" versus usual care group.
Neither the research associate, nurse, or attending physician will be blinded to the patients randomization.
Patient pain score will be assessed at baseline using VAS score.
"1+1" patients will receive 1mg hydromorphone at "timepoint 0" (baseline) followed by another 1mg after 15 minutes (along with repeat VAS pain score) if the patient answers "yes" to "Do you need more pain medicine?"
At 60 minutes, patient pain will be assessed a final time and if patient needs more pain medicine, additional treatment will be dictated by physician discretion.
Usual care group patients will also have VAS pain scores assessed at timepoint 0, 15 and 60 minutes and will have pain treated per the discretion of the attending physician.
Patients will be placed on capnometer for continuous monitoring of respiratory status to guard against any opioid induced respiratory depression.
Respiratory status, vital signs, and pain scores will be monitor to assess the efficiency of pain control as well as the safety of pain medicine administration in terms of respiratory depression.
We propose that the "1+1" hydromorphone protocol is easy to implement, as it includes a set timeline, a standard question, and a set dosage of a potent analgesic.
We hypothesize that it will provide adequate analgesia in the majority of patients without causing the anticipated level of respiratory depression.
Tipo de estudio
Intervencionista
Inscripción (Actual)
116
Fase
- No aplica
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
-
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19141
- Albert Einstein Medical Center
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-
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
60 años a 90 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Any patient who presents a condition that causes moderate to severe pain, according to the attending physician's judgment, in which the physician would order the use of parenteral analgesia
- Able to provide consent.
Exclusion Criteria:
- Patient or family member unable to consent
- Altered mental status
- SpO2 less than 95 percent
- Allergy to opiates
- Hypotension (Systolic blood pressure less than 90 mmHg)
- Chronic oxygen dependency or known CO2 retention
- Acute ETOH or drug intoxication
- History of chronic pain syndrome or chronic use of opiate narcotics
- History of opiate/heroin addiction, past or current.
- End stage renal disease/dialysis patient
- Chronic metabolic acidosis
- Physician feels that patient would be poor candidate for study
- Weight less than 100 pounds, all patients will be weighted
- Patients younger than 60 years of age
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: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: 1mg + 1mg Hydromorphone
Patient will receive 1 mg of hydromorphone for pain at timepoint 0. After 15 minutes, patients will be asked if the still need pain medication.
If yes, patients will immediately receive 1mg hydromorphone.
Patients will be under continuous monitoring for respiratory depression via capnometer.
At 60 minutes, pain will be re-assessed for a second time.
If needed, physician will give additional pain meds per their discretion.
|
1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.
Otros nombres:
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Comparador activo: Usual Care Group
Patient will receive pain medicine per doctor's discretion at timepoint 0. After 15 minutes, patients will be asked if they still need pain medication.
If yes, physicians will not be notified and patient will continue to have pain managed as deemed necessary by physician per "usual care."
Patients will be under continuous monitoring for respiratory depression via capnometer.
At 60 minutes, pain will be re-assessed for a second time.
If needed, physician will give additional pain meds per their discretion.
|
Patient will have pain treated at timepoint 0 as per usual care based on physician discretion.
At 15 min timepoint, patients will be asked for pain level, and then subsequently treated as per physician discretion.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Respiratory Depression
Periodo de tiempo: From administration of drug (time 0 minutes) to end of study (60 minute mark)
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Incidence of respiratory depression (defined as a ETCO2 of 50 mmHg or greater, a 10% change from baseline, or loss of waveform for 15 seconds or greater)
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From administration of drug (time 0 minutes) to end of study (60 minute mark)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Successful Treatment of Patient Pain
Periodo de tiempo: 15 min and 60 min after baseline
|
Defined as: Declining additional pain medication at 15 minutes or requesting additional pain medication at 15 min, but declining at 60 minutes
|
15 min and 60 min after baseline
|
Change in VAS Score
Periodo de tiempo: 15 min and 60 min after baseline
|
A 13 mm change or greater on a VAS score
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15 min and 60 min after baseline
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Hypoxia
Periodo de tiempo: From administration of drug (time 0 minutes) to end of study (60 minute mark)
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Defined as SpO2 of 93% or less for 15 seconds
|
From administration of drug (time 0 minutes) to end of study (60 minute mark)
|
Hypotension
Periodo de tiempo: Every 5 minutes from administration of drug (time 0 minutes) to end of study (60 minute mark)
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Hypotension defined as systolic blood pressure less than 90 mmHg
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Every 5 minutes from administration of drug (time 0 minutes) to end of study (60 minute mark)
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Allergic Reaction to Study Drug
Periodo de tiempo: From administration of drug (time 0 minutes) to end of study (60 minute mark)
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From administration of drug (time 0 minutes) to end of study (60 minute mark)
|
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Serious Adverse Events
Periodo de tiempo: From administration of drug (time 0 minutes) to end of study (60 minute mark)
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Defined as prolonged hypoxia, need for positive pressure ventilation or intubation, hospital admission secondary to study drug.
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From administration of drug (time 0 minutes) to end of study (60 minute mark)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
1 de diciembre de 2011
Finalización primaria (Actual)
16 de abril de 2014
Finalización del estudio (Actual)
16 de abril de 2014
Fechas de registro del estudio
Enviado por primera vez
25 de junio de 2012
Primero enviado que cumplió con los criterios de control de calidad
5 de febrero de 2013
Publicado por primera vez (Estimar)
6 de febrero de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de marzo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
6 de marzo de 2020
Última verificación
1 de diciembre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Síntomas de comportamiento
- Desordenes mentales
- Enfermedades de las vías respiratorias
- Trastornos del estado de ánimo
- Trastornos de la respiración
- Depresión
- Desorden depresivo
- Insuficiencia respiratoria
- Efectos fisiológicos de las drogas
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Analgésicos Opiáceos
- Estupefacientes
- Morfina
- Hidromorfona
Otros números de identificación del estudio
- HN - 4325
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.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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