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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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 .
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 4
Kontakter og lokationer
Studiekontakt
- Navn: Kundan Dr Kundan Kumar Yadav, Resident
- Telefonnummer: +8801782443116
- E-mail: kundanyadav1111@gmail.com
Undersøgelse Kontakt Backup
- Navn: Dr Sadeka Choudhury Moni, A. Professor
- Telefonnummer: +8801716294371
- E-mail: sadeka.moni.08@gmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 indgriben: Placebo
Will receive continuous infusion of IV fluid up to 5 days or until the end of mechanical ventilation (if interrupted before 5 days ).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse effects of fentanyl
Tidsramme: 5 days
|
Duration of mechanical ventilation (hours); chest wall rigidity (evaluated by clinical observation), diuresis, hypotension
|
5 days
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: BSMMU, Bngabandhu Sheikh Mujib Medical University
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 3491
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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