Pain relief with oral melatonin vs 24% sucrose during venipuncture in neonates
Phase 3
- Conditions
- Health Condition 1: P969- Condition originating in the perinatal period, unspecified
- Registration Number
- CTRI/2023/07/055046
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Hemodynamically stable term and preterm neonates on full enteral feeding undergoing venipuncture.
Exclusion Criteria
1)Neonates on mechanical ventilation .
2)Neonates on opioid analgesics
,sedatives or anticonvulsants .
3) Neonate with multiple congenital anomalies.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PIPP-R SCORETimepoint: Prior to Venipuncture <br/ ><br>30 seconds after venipuncture 60 seconds after venipuncture <br/ ><br>120 seconds after venipuncture in both arms.
- Secondary Outcome Measures
Name Time Method Any observed adverse effects of Melatonin & sucroseTimepoint: Upto 24 hours after procedure.