Intranasal fentanyl as add-on therapy in screening of retinopathy of prematurity - to reduce the pain associate with rop screening
Phase 4
- Conditions
- Health Condition 1: H36- Retinal disorders in diseases classified elsewhere
- Registration Number
- CTRI/2023/07/055556
- Lead Sponsor
- DR SANDIP KUMAR SAH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Preterm infants heaving gestational age
<34 weeks or birth weight < 2000 gm were screened for retinopathy of prematurity
Exclusion Criteria
Unstable neonates ( ventilate) and sedated neonate
Neonates with C/I for fentanyl
Neonates planned for surgery and neonate with congenital defects, and neurological disfunction
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -To compare the effects of intranasal fentanyl (I) with standard care (C) in reducing procedural pain related to ROP screening (O) in preterm neonates (P) to be evaluated by the premature infant pain profile - R (PIPP-R) scoreTimepoint: immediately after screening,1 minute after screening,5 minute after screening
- Secondary Outcome Measures
Name Time Method 1. . To compare the incidences of ocular and systemic side effect in neonates(due to intra nasal fentanyl) like apneic episodes, need of respiratory support and episodes of bradycardia & desaturation between the groups <br/ ><br>2.To compare the time taken to complete the procedure successfully in both <br/ ><br>Timepoint: patient was kept under abservation for next 24 hour to look out for any ocular and systemic,and local side effect