RANDOMISED CONTROLLED TRIAL TO COMPARE BETWEEN MELATONIN AND 24% SUCROSE FOR PAIN MANAGEMENT DURING ROP SCREENING
Phase 3
- Conditions
- Health Condition 1: -
- Registration Number
- CTRI/2021/02/031458
- Lead Sponsor
- KIMS HOSPITAL BHUBANESWAR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Neonate with gestational age <35 weeks, birth weight < 2000gms, requiring ROP screen and who are on atleast partial oral feeds .
Exclusion Criteria
Neonates on mechanical ventilation and/or ionotropic support during ROP screening.
Neonates on opioid analgesics, sedatives or anticonvulsants during ROP screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method umber of neonates in both arms requiring additional analgesia. <br/ ><br>Any observed adverse effects of Melatonin. <br/ ><br>Timepoint: 6 months