Health Condition 1: J960- Acute respiratory failure
Conditions
Interventions
Intervention1: Intranasal fentanyl and intravenous Placebo: Fentanyl through intranasal route will be administered rapidly in 5 seconds and Placebo (0.9% saline) through intravenous route slowly over
Sponsors
Dr Vivek S
Eligibility
Inclusion criteria
Inclusion criteria: Late preterm and Term neonates admitted in a tertiary care NICU and who require non-emergent endotracheal intubation.
Exclusion criteria
Exclusion criteria: 1. HIE stage 3; Severe encephalopathy of any cause 2. Neonates who were on mechanical ventilation requiring emergent endotracheal tube change. 3. Congenital malformations like cyanotic congenital heart, orofacial anomaly, upper airway malformations 4. Bleeding or skin ulceration from anterior nares
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the acute procedural pain after intubation using Premature Infant Pain Profile – Revised (PIPP-R) score between the intranasal fentanyl and the intravenous fentanyl group.Timepoint: 1 minute, 1 1/2 minutes, 2 minutes, 5 minutes and 10 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute adverse events within 12 hours of intubation attributed to fentanyl Timepoint: 12 hours;Number of attempts required for intubation Timepoint: At the end of intubation;Pain during intubation by FANS scaleTimepoint: During procedure;Physiological parameters including Heart rate, Blood pressure, and SpO2 before and after intubation Timepoint: Till 6 hours;Proportion of neonates undergoing traumatic intubation Timepoint: At the end of intubation;Time spent for successful intubation Timepoint: At the end of intubation | — |
Countries
India
Contacts
Public ContactKamalarathnam CN
INSTITUTE OF CHILD HEALTH AND HOSPITAL FOR CHILDREN
Outcome results
None listed