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Paracetamol or breast milk for treating pain in babies on respiratory support in NICU

Comparative efficacy of oral expressed breast milk versus oral paracetamol for pain management in neonates receiving non-invasive respiratory support. An open labelled randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/049254
Enrollment
86
Registered
2023-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: P229- Respiratory distress of newborn, unspecified

Interventions

Intervention1: Oral paracetamol syrup: 10 mg/kg/dose of paracetamol syrup will be given 6 hourly by orogastric tube to the baby for the 1st 24 hours of being on NIV support. Pain scoring by PIPP scori

Sponsors

AIIMS Mangalagiri Intramural fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All term babies admitted in NICU at AIIMS Mangalagiri and requiring NIV or CPAP or HFNC or oxygen prongs for at least 24 hours 2. Parents who have given written informed consent

Exclusion criteria

Exclusion criteria: 1. Babies on invasive ventilation, on O2 hood or free flowing oxygen 2. Any change from study protocol including the following- preterm babies, If EBM not available, if contraindication to enteral feeding or to the drug PCM, if baby goes onto invasive ventilation, if baby is on non-invasive modality for less than 24 hours, refusal to give consent, etc. 3. Any baby having any other significant cause of severe pain as follows- 1. Having central line 2. undergone intubation and invasive ventilation at birth 3. Extensive resuscitation at birth beyond 5 minutes 4. major surgical procedure

Design outcomes

Primary

MeasureTime frame
1. Comparison of mean pain scores in the two arms at baseline and at 24 hours of respiratory support 2. Comparison of mean reduction in pain scores achieved in both arms at 24 hours of respiratory support Timepoint: 1. Comparison of mean pain scores in the two arms after giving intervention (mean of all post baseline scores i.e 6,12,18 and 24 hour pain scores) 2. Comparison of mean reduction in pain scores achieved in both arms before and after giving intervention (baseline compared to 24 hour pain score)—

Secondary

MeasureTime frame
Correlation of cord blood levels of pain (beta endorphin, substance P) and oxidative stress markers with 1. Baseline 0 hour pain scores of both arms 2. Mean reduction in pain scores in both the arms after the 0 hour valueTimepoint: At baseline, at 24 hours of giving intervention—

Countries

India

Contacts

Public ContactH S Sanjana

All India Institute of Medical Sciences, Mangalagiri

sanjana.hs@aiimsmangalagiri.edu.in8940011358

Outcome results

None listed

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