Neonatal pain Retinopathy of prematurity examination N-
Conditions
Interventions
Receiving 24% oral sucrose before ROP exam.
All of infants must receive eye drop
1%tropicamide and 2.5% phenylephrine per protocol 1 drop every 15 minutes for 4 doses until ROP exam.They will be monitor for heart rate and oxygen saturation by Masimo SET Radical Signal Extraction P
PASS (Neonatal pain,
and sedation scale) by main researcher who is blinding for randomization and allocation. Then 0.2 ml of 24% oral sucrose will be dropped into infants’ into one side of buccal area by syringe in the
and sedation scale) by main researcher who is blinding for randomization and allocation. Then 0.2 ml of sterile water will be dropped into infants’ into one side of buccal area by syringe in their
Active Comparator Other,Placebo Comparator Other
24% oral sucrose,Sterile water
Sponsors
Phramongkutklao College of Medicine
Royal Thai Army Medical Service
Eligibility
Sex/Gender
All
Age
28 Days to 2 Months
Inclusion criteria
Inclusion criteria: 1.Infants with birth weight ≤ 1500 g or 2.Infants with gestational age at birth≤32 weeks or 3.Selected infants with a birth weight between 1500 and 2000 g or gestational age of more than 32 weeks with an unstable clinical course, including those requiring cardiorespiratory support and who are believed by their attending pediatrician or neonatologist to be at high-risk
Exclusion criteria
Exclusion criteria: 1.Infant requiring mechanical ventilation or oxygen supplementation 2.Infants with congenital malformations 3.Infant receiving sedation 4.Infants where consent to participate was not obtained from parents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain scores by N-PASS (Neonatal pain, agitation, and sedation scale) During first eye ROP examination ( about 2 minutes ) Observation. Pain is scored from 0 to 2 for each behavioral and physiological criteria , then summed | — |
Secondary
| Measure | Time frame |
|---|---|
| ROP staging During ROP exam ( 5 minutes ) Examination and observation,Oxygen saturation before and during ROP examination and its treatment During ROP exam ( 5 minutes ) Observation,Event of apnea and its treatment During ROP exam ( 5 minutes Observation | — |
Countries
Thailand
Contacts
Public ContactNithipun Suksumek
Phramongkutklao College of Medicine
Outcome results
None listed