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Preventing procedural pain in preterm infants during Retinopathy of Prematurity screening.

Procedural analgesia for pain during retinopathy of prematurity screening in preterm infants: A Multi-arm, Parallel group, Randomized Controlled trial comparing Multisensory stimulation, oral paracetamol, and control - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065937
Enrollment
150
Registered
2024-04-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: H36- Retinal disorders in diseases classified elsewhere

Interventions

Intervention1: 1. Multisensory Stimulation : 1. MSS: - Before engaging in stimulations, the mother will be trained by the researcher on the correct methods of performing the interventions using vide

Sponsors

DR MOUNIKA B
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Neonates who will be undergoing ROP screening as per ILROP-3 recommendation for the first time.

Exclusion criteria

Exclusion criteria: 1. Infants with IVH 3 or more 2. Infants on a mechanical ventilator, inotropes, sedatives 3. Infants who underwent any surgery 4. Major congenital anomalies - cardiac, neurological, facial palsy 5. Those infants whose mothers will not be available during the intervention 6. Infants whose parents do not consent to participate in the trial

Design outcomes

Primary

MeasureTime frame
1. To compare the mean scores of pain severity of MSS and the Control group using the PIPP-R scale during the below 10 described stages. 2. To compare the mean scores of pain severity of oral Paracetamol and the Control group using the PIPP-R scale during the below 10 described stages. 2. To compare the mean scores of pain severity of oral Paracetamol and the Control group using the PIPP-R scale during the below 10 described stages. Timepoint: - 30 seconds before examination - During the examination of the 1st eye - During the examination of the 2nd eye - 30 seconds after the end of the examination - 1 minute after the end of the examination - 1.5 minutes after the end of the examination - 2 minutes after the end of the examination - 5 minutes after the end of the examination - 30 minutes after the end of the examination - 1 hour after the end of the examination

Secondary

MeasureTime frame
1. To compare the mean scores of pain severity between the MSS and oral Paracetamol groups using the PIPP-R scale during the 10 described stagesTimepoint: - 30 seconds before examination - During the examination of the 1st eye - During the examination of the 2nd eye - 30 seconds after the end of the examination - 1 minute after the end of the examination - 1.5 minutes after the end of the examination - 2 minutes after the end of the examination - 5 minutes after the end of the examination - 30 minutes after the end of the examination - 1 hour after the end of the examination ;2. To compare the trend of mean scores of pain severity using the PIPP-R scale of all the three groups during the 10 described stages.Timepoint: - 30 seconds before examination - During the examination of the 1st eye - During the examination of the 2nd eye - 30 seconds after the end of the examination - 1 minute after the end of the examination - 1.5 minutes after the end of the examination - 2 minutes after the end of the examination - 5 minutes after the end of the examination - 30 minutes after the end of the examination - 1 hour after the end of the examination ;3. To compare the mean pain scores using the NIPS Pain Scale- Between MSS and control groups; Between oral paracetamol and control groups; Between MSS and oral paracetamol groups Timepoint: - 6 hours post procedure - 12 hours post procedure - 24 hours post procedure - 36 hours post procedure - 48 hours post procedure ;4. To compare the total cry time post-procedure- Between MSS and control groups; Between oral paracetamol and control groups; Between MSS and oral paracetamol group Timepoint: Total cry time post-procedure

Countries

India

Contacts

Public ContactKAMALARATNAM C N

Institute of Child Health and Hospital for Children, Madras Medical College, Chennai

drkamal.rathnam@gmail.com9841102746

Outcome results

None listed

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