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The efficacy of intranasal fentanyl as an adjunct for pain management in retinopathy of prematurity screening

The efficacy of intranasal fentanyl as an adjunct for pain management in retinopathy of prematurity screening

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230109003
Enrollment
22
Registered
2023-01-09
Start date
2021-03-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Efficacy of intranasal fentanyl drops as an adjunct for pain management in retinopathy of prematurity screening. Pain, retinopathy of prematurity, intranasal fentanyl

Interventions

Intranasal fentanyl (2 mcg/kg) with normal saline solution until 0.3 ml dropped both nostril prior to retinopathy of prematurity screening 5 minutes.,Intranasal normal saline 0.3 ml
Active Comparator Drug,Placebo Comparator Drug
Intranasal fentanyl drop,Intranasal normal saline

Sponsors

Bhumibol Adulyadej Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Weeks to 2 Months

Inclusion criteria

Inclusion criteria: Neonates considered at risk for retinopathy of prematurity received screening included birth weight < 1500 g or gestation age < 30 wks, and retinopathy of prematurity risk even birth weight 1500-2000 g or gestation age > 30 wk with post-menstrual age > 4 wk and underwent retinopathy of prematurity screening

Exclusion criteria

Exclusion criteria: Neonate who needed invasive mechanical ventilation, were hemodynamically unstable, under sedation, with congenital malformation or neurological dysfunction

Design outcomes

Primary

MeasureTime frame
The efficacy of intranasal fentanyl drop as an adjunct for pain management 1 h Premature infant pain profile revised

Secondary

MeasureTime frame
Safety of intranasal fentanyl drop 24 h Observation of adverse event during and after intervention at least 24 h that considered of apnea, respiratory compromise, hemodynamic and feeding intolerance

Countries

Thailand

Contacts

Public ContactNarisa Kanchanathep

Bhumibol Aduyadej hospital

Kanchanathepnarisa@gmail.com0869881441

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026