The efficacy of intranasal fentanyl as an adjunct for pain management in retinopathy of prematurity screening
Phase 4
Completed
- Conditions
- Efficacy of intranasal fentanyl drops as an adjunct for pain management in retinopathy of prematurity screening.Pain, retinopathy of prematurity, intranasal fentanyl
- Registration Number
- TCTR20230109003
- Lead Sponsor
- Bhumibol Adulyadej Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 49
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
Neonate who needed invasive mechanical ventilation, were hemodynamically unstable, under sedation, with congenital malformation or neurological dysfunction
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The efficacy of intranasal fentanyl drop as an adjunct for pain management 1 h Premature infant pain profile revised
- Secondary Outcome Measures
Name Time Method 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