Acetaminophen vs Placebo in the Pre-operative Setting and Outcomes on Post-operative Pain, Nausea and Vomiting (IV)
A Double-blind Randomized, Placebo-controlled Study to Determine the Effectiveness of Pre-operative IV Acetaminophen Administration in Reducing Post-operative Pain, Nausea, and Vomiting in the Outpatient Setting
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
The purpose of this study is to determine if using a one time pre-operative dose of IV acetaminophen has an effect on post-operative nausea, vomiting, and pain. This is a randomized, double-blind, placebo-controlled prospective study on patients from the Katzmann Breast Center undergoing outpatient breast surgery (including excisional biopsy, lumpectomy, sentinel lymph node biopsy, axillary node dissection, or ductal excision).
IV acetaminophen (paracetamol) has been in Europe and other countries. In the U.S. the FDA approved IV acetaminophen (Ofirmev) in November of 2010. Since then, it has been used in many different ways, but most commonly in the first 24 hours post operative recovery period.
There will be two arms included in this study. Patients in Arm One will receive a one gram dose of IV acetaminophen in the pre-operative area. Patients in Arm Two will receive a dose of the placebo (IV normal saline). The medication will be disguised in the same bag as the normal saline, so no one (including the patient) in the pre-operative area will know which arm the patient is in. This prospective, randomized, double blind study will compare post-operative nausea, vomiting, and pain rates in patients from both arms.
The primary endpoint of this study will be to compare post-operative pain in patients receiving a pre-operative dose of IV acetaminophen to patients receiving the normal saline placebo. Secondary endpoints will include post-operative nausea and vomiting, recovery times, and overall satisfaction of pain management throughout their experience (assessed on post operative day one). If this study shows that IV acetaminophen given in the pre-operative setting decreases post-operative nausea, vomiting, and/or pain and/or shortens recovery time, and improves patient satisfaction in regards to their pain management, it could also become a routine medication given to all patients in the pre-operative setting.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Iowa
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Des Moines, Iowa, Estados Unidos, 50314
- Mercy Medical Center-Des Moines
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Each of the following must be met:
- Greater than or equal to 18 years of age.
- Female
- Undergoing outpatient breast surgery (unilateral or bilateral surgery)
Exclusion Criteria:
If ANY of the following apply:
- History of an allergy or hypersensitivity to acetaminophen (oral, rectal, or IV)
- Chronic alcoholism
- Severe deficiency of liver and/or kidney
- Any patient unable to sign informed consent
- Pregnancy
- Any patient currently enrolled in another experimental protocol
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: IV acetaminophen
Patients in the IV acetaminophen arm will receive a one gram dose of IV acetaminophen in the pre-operative area prior to their surgery.
|
Single dose of one gram of IV acetaminophen given in pre-operative area
Otros nombres:
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Comparador de placebos: Placebo
Patients in the placebo arm will receive normal saline in the pre-operative area.
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placebo (IV normal saline)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
postoperative pain
Periodo de tiempo: first postoperative day
|
postoperative pain as measured by visual analog scale (VAS, range 0-10) measured in recovery room before discharge to outpatient setting
|
first postoperative day
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
postoperative nausea and vomiting (PONV)
Periodo de tiempo: first postoperative day
|
patient-rated postoperative nausea and vomiting (PONV) on visual analog scale
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first postoperative day
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|
time until readiness of discharge
Periodo de tiempo: first postoperative day
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time until readiness of discharge: measured from arrival to the recover room to discharge-order-written time (DOW time)
|
first postoperative day
|
|
IV analgesic consumption in recovery room
Periodo de tiempo: first postoperative day
|
intravenous analgesic consumption in recovery room: converted to morphine-equivalents
|
first postoperative day
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lauren D Allan, DO, Mercy Medical Center-Des Moines General Surgery Residency
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 (Estimar)
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
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Complicaciones Postoperatorias
- Dolor
- Manifestaciones neurológicas
- Signos y Síntomas Digestivos
- Dolor Postoperatorio
- Náuseas
- Vómitos
- Náuseas y vómitos postoperatorios
- Efectos fisiológicos de las drogas
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Analgésicos no narcóticos
- Antipiréticos
- Paracetamol
Otros números de identificación del estudio
- MMC2013-25
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