Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Pain Control After Cardiac Surgery Using Intravenous Acetaminophen

6. april 2017 opdateret af: The Cleveland Clinic

Intravenous Acetaminophen Analgesia After Cardiac Surgery: A Randomized, Blinded, Controlled Superiority Trial

Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption and/or pain intensity scores after cardiac surgery.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • - Males or females 18 years of age or older.
  • Non-emergency cardiac surgery via a midline sternotomy at Cleveland Clinic Main Campus.

Exclusion Criteria:

  1. Redo cardiac surgery.
  2. Combined CABG (Coronary Artery Bypass Graft)& valve replacement, multiple valve replacements, Ascending aortic or aortic arch surgery.
  3. Weight < 50 Kg or Body mass index > 38 kg/m2.
  4. Left ventricle EF ¡Ü 35% ,Right ventricular moderate or severe dysfunction.
  5. Severe (3-4 +) Tricuspid Regurgitation.
  6. Recent stroke (within 6 months).
  7. Severe lung disease requiring home O2 therapy.
  8. Preoperative renal insufficiency (Creatinine > 2.0) or on dialysis.
  9. History of liver cirrhosis or active liver disease.
  10. Chronic pain conditions controlled by preoperative opioid administration.
  11. Known allergy to acetaminophen or fentanyl.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: IV Acetaminophen
Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
Medicin: IV Acetaminophen
Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
Andre navne:
  • 1000mg IV Acetaminophen
Placebo komparator: Placebo
Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Medicin: Placebo
Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Andre navne:
  • inaktivt stof

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cumulative Opioid Consumption
Tidsramme: End of surgery through 24 hours after surgery
Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption a after cardiac surgery. Total opioid consumption is defined as the total amount amount of opioids administered to patients converted to mg morphine equivalents.
End of surgery through 24 hours after surgery
Pain Intensity
Tidsramme: End of surgery through 24 hours after surgery
Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing pain intensity scores after cardiac surgery. Pain scores were measured on the Numeric Rating scale, ranging from 0 to 10 (where 0 indicates no pain and 10 indicates the worst pain imaginable).
End of surgery through 24 hours after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Nausea and Vomiting
Tidsramme: End of surgery through 24 hours after surgery
Incidence of any postoperative nausea and vomiting within 24 hours after surgery was collected.
End of surgery through 24 hours after surgery
Postoperative Sedation
Tidsramme: Measured at 8, 16, and 24 hours after surgery
Postoperative sedation was assessed using the Richmond Agitation Sedation Scale (RASS). It ranges from -5 to +4, where -5 indicates no response to voice or physical stimulation and +4 indicates overtly combative or violent and immediate danger to staff. Lower the value, better the sedation.
Measured at 8, 16, and 24 hours after surgery
Duration of Mechanical Ventilation (Minutes)
Tidsramme: End of surgery until the initial end of ventilation or date of death from any cause, whichever came first, assessed up to 1 week.
Evaluate whether IV acetaminophen reduced duration of Mechanical Ventilation.
End of surgery until the initial end of ventilation or date of death from any cause, whichever came first, assessed up to 1 week.
Intensive Care Unit (ICU) Length of Stay
Tidsramme: End of surgery through discharge from ICU
Evaluate whether IV acetaminophen reduced intensive care unit (ICU) Length of Stay.
End of surgery through discharge from ICU
Hospital Length of Stay
Tidsramme: end of surgery through hospital discharge
Evaluate whether IV acetaminophen hospital length of stay
end of surgery through hospital discharge
Alanine Aminotransferase (ALT); U/L
Tidsramme: Two days after surgery or date of death from any cause, whichever came first
Two days after surgery or date of death from any cause, whichever came first
Aspartate Aminotransferase (AST); U/L
Tidsramme: Two days after surgery or date of death from any cause, whichever came first
Two days after surgery or date of death from any cause, whichever came first
Total Bilirubin (mg/dL)
Tidsramme: Measured at 1 day and 2 days after surgery
Measured at 1 day and 2 days after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Cleveland Clinic

Efterforskere

  • Ledende efterforsker: Negmeldeen Mamoun, MD, The Cleveland Clinic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2013

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. marts 2015

Datoer for studieregistrering

Først indsendt

28. marts 2013

Først indsendt, der opfyldte QC-kriterier

1. april 2013

Først opslået (Skøn)

2. april 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 13-269

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Smerte

Kliniske forsøg med IV Acetaminophen

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in New Zealand

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner