Efficacy and Safety of Fentanyl for Pain Control in Newborn on Mechanical Ventilation
Efficacy and Safety of Fentanyl for Pain Control in Newborns on Mechanical Ventilation
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
This Randomized Controlled Trial will be conducted in the Department of Neonatology, BSMMU, Dhaka after approval by Institutional Review Board (IRB). A Written informed consent will be obtained before enrollment in the study from the parents or guardians. . The study cohort will comprise all inborn and outborn newborns admitted to the neonatal intensive care unit (NICU) who receive mechanical ventilation administered through an endotracheal tube . The enrolled neonates will be randomly assigned with computer-generated random number tables via software named 'Random Allocation Software', to receive either of the intervention.
Once the parents will agree to the study and provide signed informed consent, all eligible neonates will be randomized to start treatment within 24 hours from the initiation of mechanical ventilation. Randomized infants will be allocated to the fentanyl group to receive a continuous infusion of fentanyl or to the placebo group to receive a continuous infusion of iv fluid.
Fentanyl will be administered as an intravenous loading dose of 1 microgram/kg in 30 minutes, followed by a continuous intravenous infusion of 1μg/kg/hour. The infusion will be administered through a peripheral line. Fentanyl infusion will be initiated within 24 hours after the start of mechanical ventilation and will be continued until the end of mechanical ventilation, and not longer than 5 days .
Studietype
Registrering (Forventet)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: Kundan Dr Kundan Kumar Yadav, Resident
- Telefonnummer: +8801782443116
- E-post: kundanyadav1111@gmail.com
Studer Kontakt Backup
- Navn: Dr Sadeka Choudhury Moni, A. Professor
- Telefonnummer: +8801716294371
- E-post: sadeka.moni.08@gmail.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- All inborn and outborn newborns admitted to the neonatal intensive care unit (NICU) who received mechanical ventilation administered through an endotracheal tube.
- Newborn on mechanical ventilator for at least 72 hours.
Exclusion Criteria:
- Known genetic or chromosomal disorders,
- The need for postoperative analgesic therapy during the study period,
- Major congenital anomaly,
- Those who received drugs like midazolam, paracetamol, morphine, muscle relaxants, phenobarbital, phenytoin, and chloral hydrate during the study period.
- Probable rapid extubation.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Fentanyl
Fentanyl will be given within 24 hours from the initiation of mechanical ventilation at an intravenous loading dose of 1 microgram/kg in 30 minutes, followed by a continuous intravenous infusion of 1μg/kg/hour up to 5 days or until the end of mechanical ventilation (if interrupted before 5 days ).
|
Fentanyl will be administered as an intravenous loading dose of 1 microgram/kg in 30 minutes, followed by a continuous intravenous infusion of 1μg/kg/hour.
The infusion will be administered through a peripheral line.
Fentanyl infusion will be initiated within 24 hours after the start of mechanical ventilation and will be continued until the end of mechanical ventilation, and not longer than 5 days .
|
|
Ingen inngripen: Placebo
Will receive continuous infusion of IV fluid up to 5 days or until the end of mechanical ventilation (if interrupted before 5 days ).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Decrease in Neonatal Pain Agitation and Sedation Scale (NPASS) score.
Tidsramme: 5 days
|
If fentanyl is able to decrease NPASS pain score.
Total score is 13.
A mean difference of 3 points will be considered clinically relevant.
|
5 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse effects of fentanyl
Tidsramme: 5 days
|
Duration of mechanical ventilation (hours); chest wall rigidity (evaluated by clinical observation), diuresis, hypotension
|
5 days
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: BSMMU, Bngabandhu Sheikh Mujib Medical University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 3491
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
Legemiddel- og utstyrsinformasjon, studiedokumenter
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