Using Intranasal analgesia to reduce pain in premature babies during retinopathy of prematurity screening

Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity in Preterm Infants: A Randomized Controlled Trial - INDEX-ROP Trial (INtranasal DEXmedetomidine for pain management during screening for Retinopathy Of Prematurity)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110260

Enrollment

Registered

2026-05-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: H351- Retinopathy of prematurity

Interventions

Intervention1: Single dose of Intranasal dexmedetomidine at 1.5 micrograms/kg/dose: Intranasal dexmedetomidine 1.5 micrograms/kg diluted in normal saline given at 45 minutes pre procedure through a mu

Eligibility

Inclusion criteria

Inclusion criteria: All neonates fulfilling unit criteria for ROP screening and undergoing ROP screening up to 38 weeks postmenstrual age

Exclusion criteria

Exclusion criteria: 1.Neonates who received Paracetamol or Fentanyl, or any analgesics in the last 96 hours for pain control or sedation (Persistent pulmonary hypertension of the newborn) will be excluded. 2. Any malformation involving the nasal cavity, like choanal atresia 3. Neonates on mechanical ventilation or inotropic support and/or sedated during the scheduled ROP examination 4. Neonates having grade more than 2 Intracranial haemorrhage, Congenital malformations, genetic syndromes, neurological dysfunction

Design outcomes

Primary

Measure	Time frame
PIPP-R ScoreTimepoint: At 30 seconds post procedure (post speculum removal)	—

Secondary

Measure	Time frame
PIPP-R scoreTimepoint: 30 seconds of speculum insertion At 2 minutes post procedure At 5 minutes post procedure;Increase in baseline oxygen requirement by 5 percent or moreTimepoint: within 24 hours post procedure;Incidence of new onset apneas and desaturationsTimepoint: within 24 hours post procedure;Occurrence of new onset or exacerbation of feed intoleranceTimepoint: within 24 hours post procedure;Incidence of new onset bradycardia, hypotension, desaturations, rashTimepoint: Within 24 hours of administration of dexmedetomidine;Cardio respiratory stability scoreTimepoint: For 24 hours post administration of intranasal dexmedetomidine;Hammersmith Neonatal Neurological Examination ScoreTimepoint: 40 weeks post menstrual age	—

Measure

Time frame

PIPP-R scoreTimepoint: 30 seconds of speculum insertion At 2 minutes post procedure At 5 minutes post procedure;Increase in baseline oxygen requirement by 5 percent or moreTimepoint: within 24 hours post procedure;Incidence of new onset apneas and desaturationsTimepoint: within 24 hours post procedure;Occurrence of new onset or exacerbation of feed intoleranceTimepoint: within 24 hours post procedure;Incidence of new onset bradycardia, hypotension, desaturations, rashTimepoint: Within 24 hours of administration of dexmedetomidine;Cardio respiratory stability scoreTimepoint: For 24 hours post administration of intranasal dexmedetomidine;Hammersmith Neonatal Neurological Examination ScoreTimepoint: 40 weeks post menstrual age

—

Countries

India

Contacts

Public ContactDr Neeraj Gupta

All India Institute of Medical Sciences, Jodhpur

neerajpgi@yahoo.co.in8003996908

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026