Reduce Nonsteroidal Antiinflammatory Drugs Doses for Analgesia After Sternotomy
Cardiac Surgery · Post-operative Pain
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 2
- Rango de edad
- 18 años - 75 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 100 Real
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
Currently, the management of pain after cardiac surgery is based on the concept of multimodal analgesia: Combined use of non-opioid analgesics associated with morphine intravenous analgesia by a system controlled by the patient (patient-controlled analgesia-PCA).
The combination of paracetamol and morphine PCA is very effective on pain at rest, but is limited on pain mobilization and causes the problem of side effects associated with opioid (overdose, sedation, respiratory depression, gastrointestinal intolerance, urinary retention ...) which are contributing factors to increase the length of stay in Intensive Care Unit, an additional cost of care and an increase postoperative morbidity and mortality.
Methods that have proved their effectiveness on pain and mobilization used in postoperative cardiac surgery are: anti-inflammatory drugs (NSAIDs) and / or loco-regional analgesia techniques. NSAIDs enhance analgesia produced by PCA Morphine and allow a reduction in morphine consumption, improved postoperative pain, decreased sedation and decreased postoperative morbidity and mortality.
Adverse effects of NSAIDs are commensurate with their time and exposure dose. Consequently, NSAIDs, in the absence of against-indications, should always be prescribed and used at the lowest effective dose and for the shortest possible time.
Some studies have suggested that lower doses of NSAIDs didn't appear to affect their effectiveness. At present, the investigators have no studies that address the hypothesis from which minimum dose of ketoprofen analgesic effect is obtained.
The investigators hypothesis is that lower dose ketoprofen may have efficacy on pain in the postoperative mobilization of cardiac surgery. The investigators want to find, in their study, this "optimal" ketoprofen dose which would be the minimum dose for clinical efficacy demonstrated dose.
This optimal dose could reduce the number of adverse effects of NSAIDs, but their study will probably not have enough power to prove it. NSAID use at these low doses, in postoperative cardiac surgery, could be extended to patient populations most at risk or for a duration longer than 48 hours.
Leer la descripción completa
To answer this hypothesis the investigators will consider starting a study of four groups of patients where appropriate doses to patient weight gradually increasing ketoprofen will be used in seeking the minimum effective dose.
Four groups will be determined by randomization. In all these groups, analgesia will be supplemented by a systematic standard self-administered treatment with morphine and paracetamol.
- Group 1 : Placebo group (P). 0 mg/kg ketoprofen IV every 6 hours for 48 hours (or 0 mg/kg every 24 hours) for 48 hours.
- Group 2 : "Ketoprofen quarter dose" (K ¼). 0,125 mg/kg ketoprofen IV every 6 hours (0,5 mg/kg every 24 hours) for 48 hours.
- Group 3 : "Ketoprofen half-dose" (K ½). 0,25 mg/kg ketoprofen IV every 6 hours (1 mg/kg every 24 hours) for 48 hours.
- Group 4 : "Ketoprofen full dose" (KPD). 0,5 mg/kg ketoprofen IV every 6 hours (or 2 mg/kg every 24 hours) for 48 hours.
¿Quién podría participar?
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Inclusion Criteria:
- Patients scheduled for a cardiac surgery (Coronary artery bypass graft, valve replacement)
- Age over 18 years
- Weight between 60 and 100 kg
- Absence of criteria for non-inclusion
Exclusion Criteria:
- Age over 75 years
- Renal insufficiency (MDRD \<60 ml / min)
- Hepatic Insufficiency
- Congestive heart failure (EF \<40%)
- Insulin-requiring diabetes
- Preoperative coagulation trouble
- History of peptic ulcer or gastrointestinal bleeding
- Allergy to NSAIDs
- Surgery in emergency, aorta surgery, heart transplantation
- Peptic ulcer scalable, history of peptic ulcer or recurrent bleeding (2 or more distinct episodes of bleeding or ulceration objectified)
- Pregnant or lactating women
- Major protected
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento doble
placebo group
Group 1 : Placebo group (P). 0 mg/kg ketoprofen IV every 6 hours for 48 hours (or 0 mg/kg every 24 hours) for 48 hours
Drug: Ketoprofen
ketopofen quarter dose
Group 2 : "Ketoprofen quarter dose" (K ¼). 0,125 mg/kg ketoprofen IV every 6 hours (0,5 mg/kg every 24 hours) for 48 hours.
Drug: Ketoprofen
ketoprofen half-dose
Group 3 : "Ketoprofen half-dose" (K ½). 0,25 mg/kg ketoprofen IV every 6 hours (1 mg/kg every 24 hours) for 48 hours.
Drug: Ketoprofen
Ketoprofen full dose
Group 4 : "Ketoprofen full dose" (KPD). 0,5 mg/kg ketoprofen IV every 6 hours (or 2 mg/kg every 24 hours) for 48 hours
Drug: Ketoprofen
Ketoprofen DRUG
No informado en este registro.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Pain at the mobilization
Plazo: At the first 48 hours postoperatively
Pain at the mobilization of the first 48 hours postoperatively, measured every 4 hours by simple numerical scale or VAS (0: no pain to 10: unbearable pain)
Medidas secundarias
Demographic criteria
Plazo: at day 1
No informado en este registro.
Quantity of sufentanil administered intraoperatively
Plazo: at day 1
No informado en este registro.
Pain at rest measured by Visual Analogue Scale
Plazo: at day 1
Pain at rest measured every 4 hours from H0+4 hours to H+48 hours by Visual Analogue Scale (H0 : sedation stop time, 1 hour before waking)
Total morphine consumption
Plazo: from H0 to H0+48 hours
No informado en este registro.
Blood gas monitoring 3 times a day
Plazo: from H0 to H0+48 hours
No informado en este registro.
Time of removal of drains after surgery
Plazo: at day 1
No informado en este registro.
Resumption of transit characterized by the first gas time after surgery.
Plazo: at day 1
No informado en este registro.
Nausea occurrence (number of episodes) assessed every 4 hours
Plazo: from H0 to H0 +48 hours
No informado en este registro.
Vomiting occurrence (number of episodes) assessed every 4 hours
Plazo: from H0 to H0 +48 hours
No informado en este registro.
Effective Duration of stay in the Intensive Care Unit
Plazo: at day 1
No informado en este registro.
Patient satisfaction for its first mobilization assessed by simple scale Likert
Plazo: at H0+ 48 hours
No informado en este registro.
Occurrence of the following complications: Renal respiratory cardiac Neurological infectious Hemorrhagic
Plazo: From H0 to H0+48 hours
No informado en este registro.
Any readmission to the intensive care unit in the two weeks following the surgery
Plazo: at day 7
No informado en este registro.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
CHU de Clermont-FerrandClermont-Ferrand, FranceEstado desconocido
Equipo y fechas
- Patrocinador principal
- University Hospital, Clermont-Ferrand
- Inicio del estudio
- 1 feb 2014 Real
- Finalización primaria
- 1 sept 2016 Real
- Finalización del estudio
- 1 sept 2016 Real
- Primera publicación
- 2 jul 2014 Estimado
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Reduce Nonsteroidal Antiinflammatory Drugs Doses for Analgesia After Sternotomy
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026