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

Safety and Efficacy of a Low Dose Naloxone Infusion in NICU Patients

19. juli 2011 opdateret af: Children's Mercy Hospital Kansas City

When narcotic pain medicine, like fentanyl or morphine, is given to adults and children for several days, they often develop a tolerance to the medicine. This means they may need higher doses over time to get the same amount of pain control. When it is time to stop the medicine, the dose has to be decreased slowly so that the patient does not have withdrawal symptoms.

Naloxone is a medicine that at high doses can reverse the effects of narcotics. At very small doses it may help prevent tolerance and lessen the severity of withdrawal symptoms. This could mean less narcotic pain medicine is needed over fewer days.

The purpose of this research study is to see if giving naloxone to neonates who require narcotic infusions is safe and effective. Safety will be measured by the incidence of side effects. Efficacy will be measured by monitoring for changes in pain and sedation scores and need for more pain medicine.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This is a prospective, non-randomized, single center, open label dose escalation study. We hypothesize that critically ill patients in the NICU may benefit from a low dose naloxone infusion resulting in decreased tolerance, less severe withdrawal symptoms, lower cumulative doses of opiates, and fewer total days of opiates, all while maintaining adequate or enhanced pain control and sedation. Establishing safety and efficacy data for this potentially beneficial therapy is an important first step towards using this therapy to decrease the risk of opioid tolerance and withdrawal in this population of infants.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

25

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64108
        • Children's Mercy Hospital

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

1 dag til 4 uger (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Neonates admitted to the NICU within the first five days of life with an anticipated need for opiate infusion for at least four days

Beskrivelse

Inclusion Criteria:

  • Neonates > 36 0/7 weeks estimated gestational age
  • Less than 30 days of life
  • Requiring admission to to the Neonatal Intensive Care Unit
  • Requiring continuous infusions of fentanyl or morphine analgesia
  • Anticipated to require opioid infusions for at least four days
  • Patients must be enrolled within 120 hours of initiating opioid infusions
  • All patients will also require mechanical ventilation prior to study entry.

Exclusion Criteria:

  • Preterm infants < 36 weeks gestation
  • Neonates with major neurologic anomalies, seizures
  • Opioid infusion administration for > 120 hours prior to study entry
  • Patients requiring ECMO support prior to study entry
  • Neonates born to mothers who are known to be opioid dependent

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The primary outcome variable will be a change in N-PASS scores. N-PASS scores will be compared before, during, and after administration of naloxone.
Tidsramme: Before, during, and after administration of naloxone
Before, during, and after administration of naloxone

Sekundære resultatmål

Resultatmål
Tidsramme
The secondary outcome variable will be any changes in dosing of opioids within four hours of initiating or increasing naloxone infusion. Vital signs will be recorded per NICU protocol and closely monitored for changes.
Tidsramme: Collected and compared for the time period before, during, and for 5 days after naloxone infusion is administered
Collected and compared for the time period before, during, and for 5 days after naloxone infusion is administered

Samarbejdspartnere og efterforskere

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

Sponsor

Children's Mercy Hospital Kansas City

Efterforskere

  • Ledende efterforsker: Eugenia K Pallotto, MD, Children's Mercy Hospital Kansas City

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. februar 2008

Studieafslutning (Faktiske)

1. juni 2011

Datoer for studieregistrering

Først indsendt

24. april 2008

Først indsendt, der opfyldte QC-kriterier

28. april 2008

Først opslået (Skøn)

29. april 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. juli 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juli 2011

Sidst verificeret

1. juli 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 08 01-003

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

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Malta

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner