RANDOMISED CONTROLLED TRIAL TO COMPARE BETWEEN MELATONIN AND 24% SUCROSE FOR PAIN MANAGEMENT DURING ROP SCREENING

COMPARISION BETWEEN MELATONIN AND 24% SUCROSE FOR PAIN MANAGEMENT DURING ROP SCREENING-A RANDOMISED CONTROL TRIAL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/02/031458

Enrollment

Registered

2021-02-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: -

Interventions

Intervention1: SYP MELATONIN: oral melatonin suspension, 4mg/kg , to be given 20 minutes prior to ROP Screening . Control Intervention1: 24% SUCROSE SOLUTION: oral 24% sucrose solution, 0.5ml, to be g

Eligibility

Inclusion criteria

Inclusion criteria: Neonate with gestational age <35 weeks, birth weight < 2000gms, requiring ROP screen and who are on atleast partial oral feeds .

Exclusion criteria

Exclusion criteria: Neonates on mechanical ventilation and/or ionotropic support during ROP screening. Neonates on opioid analgesics, sedatives or anticonvulsants during ROP screening.

Design outcomes

Primary

Measure	Time frame
PIPP SCORE during ROP screening ,at 1 minute after and 5 minute after the procedure in both armsTimepoint: PIPP SCORE during ROP screening ,at 1 minute after and 5 minute after the procedure in both arms	—

Secondary

Measure	Time frame
Number of neonates in both arms requiring additional analgesia. Any observed adverse effects of Melatonin. Timepoint: 6 months	—

Countries

India

Contacts

Public ContactDR SUSHREE SMITA BEHURA

KIMS HOSPITAL BHUBANESWAR

sushree.rani87@gmail.com9437084476

Outcome results

None listed

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