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Intranasal fentanyl as add-on therapy in screening of retinopathy of prematurity - to reduce the pain associate with rop screening

Phase 4
Not yet recruiting
Conditions
Retinal disorders in diseases classified elsewhere,
Registration Number
CTRI/2023/07/055556
Lead Sponsor
DR SANDIP KUMAR SAHU
Brief Summary

Retinopathy of prematurity (ROP) affects premature LBW infants. Early exposure to high ambient oxygen concentration appears to be a risk factor. systemic conditions like RDS, sepsis

, any kind of blood transfusion and anemia also play a key role. Nasal retina vascularizedafter 8 months of gestation and temporal after 1 month of delivery. Retinopathy of prematurity evolves through two phases. It begins with delayed vascular growth after premature birth (phase 1). Phase 2 follows when phase 1 induced hypoxia releases factor to stimulate new blood vessel growth. vascular epithelial growth factor (VEGF) is thought to play important role in this. genesis of ROP

 Screening for ROP is an standard age-old practice in neonate ICU. Premature neonates experience a considerable amount of pain owing to speculum ROP screening from the insertion of a speculum, scleral indentation, and from the illumination of the ophthalmoscope. So here the pain are multimodal.(1) ROP screening produces short-lasting pain which is experienced mainly by non-ventilated neonates. The healthcare personnel have to depend on behavioral and physiological responses of neonates to grade the distress and pain cause during screening as they cannot verbalize their pain.

 For the purpose of screening the pupil of the premature infants dilated with 0.8% tropicamide and 2.5% phenylephrine. topical anesthetics are installed and Topical anesthetic drop (proparacaine) is instilled before application of the neonatal eyelid eye speculum is used. Local anesthetic eye drops, swaddling, skin to skin care, gauge socked with expressed breast milk, non-nutritive sucking, have been evaluated in many clinical trials over past decade found to be inadequate effects on the pain associated with retinopathy of prematurity (ROP) screening. Meta-analyses study also concur that no single intervention was absolutely effective in reducing pain in ROP screening. The most optimal approach to relief the pain associated with retinal examination could be through engage in cluster of interventions, including analgesic medications. (1)

 In pediatric patient Intranasal fentanyl is found to be safe and well-tolerated as analgesic method in pre-and post-operative pain control. The moa of fentanyl is it mainly acts through mu-opioid receptor. This route is a fast and easy way to achieve a clinically effective blood level

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
80
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
NameTimeMethod
-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) scoreimmediately after screening,1 minute after screening,5 minute after screening
Secondary Outcome Measures
NameTimeMethod
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 groups2.To compare the time taken to complete the procedure successfully in both

Trial Locations

Locations (1)

AIIMS Bhubaneswar

🇮🇳

Khordha, ORISSA, India

AIIMS Bhubaneswar
🇮🇳Khordha, ORISSA, India
Dr Sandip Kumar Sahu
Principal investigator
7978243970
drsandipsahu@yahoo.com

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