Health Condition 1: H351- Retinopathy of prematurity
Conditions
Interventions
Intervention1: Intranasal dexmedetomidine: Intranasal route , dose 1 microgram/kg, given once 30 minutes before starting of procedure
Control Intervention1: Placebo Normal saline: Intranasal route , 0
Sponsors
Animesh Sahu
Eligibility
Inclusion criteria
Inclusion criteria: Gestational age less than 34 weeks and birth weight less than 2 kgs and post menstrual age less than 44 weeks
Exclusion criteria
Exclusion criteria: 1. Major congenital anomalies 2. Chromosomal / genetic anomalies 3. Neonate received an opioid analgesic drug in last 72 hours 4. Eye examination for reasons other than ROP screening 5. Attending physician deemed the patient not stable enough to undergo ROP screening 6. Neonates on invasive mechanical ventilation. 7. Neonates with intraventricular haemorrhage (IVH) = grade 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Premature infant pain profile revised (PIPP R) score after the insertion of eyelid retractor in the first eye of neonates undergoing screening for Retinopathy of prematurityTimepoint: 30 second window frame after the insertion of eyelid retractor in the first eye | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)To compare PIPP-R score at 1 minute after the completion of the procedure between control and intervention group. 2)a) Maximum heart rate during the procedure b)Minimum Spo2 during the procedure 3)Proportion of neonates in each group having an episode of the following events within 4 hour post procedure, a)Apnoea requiring positive pressure ventilation (PPV) b)Persistent desaturation requiring any respiratory support or any increase in the existing respiratory support c)Hypotension requiring administration of fluid bolus/ inotrope Timepoint: 1 minute post completion of procedure . Within 4 hours post procedure | — |
Countries
India
Contacts
Public ContactRameshwar Prasad
AIIMS Patna
Outcome results
None listed