A study to compare two different ways of giving fentanyl drugâ?? continuous infusion or intermittent doses for pain relief in newborn babies

Comparison of continuous infusion versus intermittent bolus doses of fentanyl for analgesia in neonatesâ?? An open label randomized controlled trial - FANCI trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/11/005190

Enrollment

Registered

2014-11-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Analgesia and Sedation for neonates on mechanical ventilation

Interventions

Intervention1: Intermittent doses of fentanyl: Intermittent doses of fentanyl 1 microgram/kg/dose once every 4 hours for 48 hours (minimum 24 hours) Control Intervention1: Continuous infusion of fenta

Eligibility

Inclusion criteria

Inclusion criteria: Newborn babies who are likely to require mechanical ventilation for 48 hours (minimum 24 hours)

Exclusion criteria

Exclusion criteria: 1.Major congenital anomalies/ chromosomal disorders 2.Hypoxic Ischemic encephalopathy (HIE) stage 2 or 3 3.Postoperative babies 4.Refusal of consent

Design outcomes

Primary

Measure	Time frame
To compare the exposure as concentrations of Fentanyl achieved in the serum between the two groupsTimepoint: Continuous Infusion - Fentanyl serum concentrations at: 0, 2, 8, 24 hours on DAY 1. 36 and 48 hours on DAY 2. Intermittent dosage Group - Fentanyl serum concentrations as peak and trough concentrations for dose 1 and 6â??DAY 1, peak and trough for dose 12 (or last dose, whichever is later) on DAY 2	—

Measure

Time frame

To compare the exposure as concentrations of Fentanyl achieved in the serum between the two groupsTimepoint: Continuous Infusion - Fentanyl serum concentrations at: 0, 2, 8, 24 hours on DAY 1. 36 and 48 hours on DAY 2. Intermittent dosage Group - Fentanyl serum concentrations as peak and trough concentrations for dose 1 and 6â??DAY 1, peak and trough for dose 12 (or last dose, whichever is later) on DAY 2

—

Secondary

Measure	Time frame
To measure the exposure as Cmax (when measured) at each bolus and AUC, through the 24 hour (or 48 hour) period, using limited time points, in babies receiving intermittent bolus doses of fentanylTimepoint: Fentanyl serum concentrations as peak and trough concentrations for dose 1 and 6 on DAY 1, peak and trough for dose 12 (or last dose, whichever is later) on DAY 2;To compare the analgesic efficacy between continuous infusion and intermittent bolus doses of fentanyl using pain scoresTimepoint: Day 1 and 2 of fentanyl;To compare the side effects of fentanyl between the two groupsTimepoint: Day 1 and 2 of fentanyl;To find the inter-individual variability in serum concentrations of fentanyl in the two groups, especially the effect of gestational age on fentanyl clearanceTimepoint: Day 1 and 2 of fentanyl;To measure the exposure as Cmax (peak concentration) and area under concentration time curve (AUC 0-24 hours or AUC 0-48 hours) in babies receiving continuous infusion of fentanylTimepoint: Fentanyl serum concentrations at 0, 2, 8, 24 hours on DAY 1 and 36, 48 hours on DAY 2	—

Measure

Time frame

To measure the exposure as Cmax (when measured) at each bolus and AUC, through the 24 hour (or 48 hour) period, using limited time points, in babies receiving intermittent bolus doses of fentanylTimepoint: Fentanyl serum concentrations as peak and trough concentrations for dose 1 and 6 on DAY 1, peak and trough for dose 12 (or last dose, whichever is later) on DAY 2;To compare the analgesic efficacy between continuous infusion and intermittent bolus doses of fentanyl using pain scoresTimepoint: Day 1 and 2 of fentanyl;To compare the side effects of fentanyl between the two groupsTimepoint: Day 1 and 2 of fentanyl;To find the inter-individual variability in serum concentrations of fentanyl in the two groups, especially the effect of gestational age on fentanyl clearanceTimepoint: Day 1 and 2 of fentanyl;To measure the exposure as Cmax (peak concentration) and area under concentration time curve (AUC 0-24 hours or AUC 0-48 hours) in babies receiving continuous infusion of fentanylTimepoint: Fentanyl serum concentrations at 0, 2, 8, 24 hours on DAY 1 and 36, 48 hours on DAY 2

—

Countries

India

Contacts

Public ContactAbiramalatha T

Christian Medical College, Vellore

anilkk@cmcvellore.ac.in04163073311

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 23, 2026