Health Condition 1: H36- Retinal disorders in diseases classified elsewhere
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
Institute of Child Health and Hospital for Children, Madras Medical College, Chennai