Efficacy and safety of intranasal dexmedetomidine as an adjunct to standard pain control measures during retinopathy of prematurity screening in neonates: A randomized controlled trial

Efficacy and safety of intranasal dexmedetomidine on pain control during retinopathy of prematurity screening in neonates: A randomized controlled trial

Retinopathy of prematurity (ROP) is a vasoproliferative disorder of retina characterised by inadequate retinal blood vessel formation .ROP screening is a painful procedure; multiple causes of pain

•       Insertion of an eyelid speculum

•       Exposure to bright light to illuminate the fundus

•       Scleral indentation due to manipulation of the eye during examination

 Screening for ROP: Physiological stress and increased risk of apneic episodes, seizures and feed intolerance . Implications for future health and neurodevelopment of neonates

 Practices followed for pain relief:

 

Non pharmacological

Pharmacological

|Swaddling ,Containment

Oral sweetners:24% sucrose /25% dextrose .

|Skin to skin care

Local anesthetic eye drops

|Non nutritive sucking

Paracetamol

|Expressed breast milk

Opioids : Fentanyl/morphine

 No single intervention or a combination of interventions completely abolishes procedure-related pain .Recommendations for pain management during ROP screening not universal.No standard treatment guidelines for peri-procedural pain relief in ROP . So main aim of our study is to Identify an effective and safe analgesic with alternate mechanism of action with minimal side effects.

 In neonates undergoing their first ROP screening with standard pain management procedures*, does use of 1 microgram/kg intranasal dexmedetomidine thirty minutes prior to the start of the procedure lead to decrease in pain as assessed by Premature infant pain profile revised (PIPP-R) score, in comparison to a placebo.

 *Standard pain management procedures =  Swaddling+ oral dextrose 25% (0.5 ml/kg)+ topical proparacaine eye drops (0.5%)

Double arm, Parallel group, Randomized control  trial

To be done Level III NICU & Ophthalmology Day care, AIIMS PATNA

From Jan 2025 till May 2026

Inclusion criteria of babies with birth weight less than 2000 gm OR Gestational age less than 34 weeks AND post-menstrual age <44 weeks at the time of first ROP screening .

 Exclusion criteria :

•       Major congenital anomaly

•       Chromosomal / genetic anomalies

•       Neonate who received an opioid analgesic drug in last 72 hours

•       Eye examination for reasons other than ROP screening

•       Attending physician deemed the patient not stable enough to undergo ROP screening

•       Neonates on invasive mechanical ventilation.

•       Neonates with IVH ≥ grade 3

 Procedure : Single intranasal dexmedetomidine at a dose of 1 microgram/kg of current body weight diluted with normal saline to 0.3 ml total volume administered into nostrils thirty minutes before starting the procedure OR Single dose of placebo (0.3 ml normal saline) intranasally thirty minutes before starting the procedure.

 Outcome :Primary will be the effect of intranasal dexmedetomidine on PIPP-R score in 30 second window after the insertion of the eyelid retractor in the first eye of neonates undergoing screening for ROP.

Secondary outcome will be

·      The PIPP-R  score 1 minute after the completion of the procedure.

·      Physiological stability as assessed by changes in the heart rate, Spo2 and blood pressure from the baseline, till 1 hour post-procedure

·      Any adverse event like apnoea, desaturation or  hypotension requiring intervention within 4 hours post-procedure.