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Using a combination of nasal Fentanyl and Paracetamol (Pain control drug) works better to control pain than just Paracetamol (Pain control drug) alone in newborns getting regular eye check-up.

Comparing the efficacy of Intranasal Fentanyl along with Paracetamol in reduction of pain to Paracetamol alone in neonates undergoing ROP examination- A randomised controlled trial.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076929
Enrollment
108
Registered
2024-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: P09- Abnormal findings on neonatal screening

Interventions

Intervention1: Intranasal Fentanyl and Oral Paracetamol: Oral Paracetamol: The neonate will receive Oral Paracetamol Syrup (Paracet-S 5ml/125mg) at 15mg per kg of body weight, given 30 minutes before

Sponsors

AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All neonates admitted to the NICU fulfilling the criteria for ROP screening as per our unit protocol.

Exclusion criteria

Exclusion criteria: 1. Neonates who received Paracetamol or Fentanyl or any analgesics in the last 48 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, etc.

Design outcomes

Primary

MeasureTime frame
Pain reduction will be measured using the PIPP-R score for the first 30 seconds after the ROP screening procedure.Timepoint: Immediately for 30 seconds after the ROP screening procedure

Secondary

MeasureTime frame
Compare the PIPP-R score in both groupsTimepoint: After speculum insertion and 2minutes, 5 minutes post ROP screening;To observe the increase or new onset of apnea, desaturation episodes, and their severity Timepoint: 48 hours following the ROP examination;To observe the occurrence of new-onset or exacerbation of feed intoleranceTimepoint: 48 hours following the procedure;To observe the heart rate patterns and Blood PressureTimepoint: Till 3 hours following the procedure;To evaluate the adverse effects profile of intranasal fentanylTimepoint: 48 hours post-administration.;To assess the cardiorespiratory stability scoreTimepoint: 48 hours post administration of intervention

Countries

India

Contacts

Public ContactDr Sushil Kumar Choudhary

AIIMS Jodhpur

drsusil85@gmail.com9013355932

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026