Pain relief with oral melatonin vs 24% sucrose during venipuncture in neonates

Oral Melatonin vs 24% sucrose for pain relief during venipuncture in neonates- a non-inferiority randomised controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055046

Enrollment

120

Registered

2023-07-11

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

Health Condition 1: P969- Condition originating in the perinatal period, unspecified

Interventions

Intervention1: Oral melatonin: oral melatonin suspension at 1mg/kg dose 30 minutes prior to painful procedure. Control Intervention1: ORAL 24% SUCROSE: 1 ml oral 24% sucrose solution, 2 minutes prior

Eligibility

Inclusion criteria

Inclusion criteria: Hemodynamically stable term and preterm neonates on full enteral feeding undergoing venipuncture.

Exclusion criteria

Exclusion criteria: 1)Neonates on mechanical ventilation . 2)Neonates on opioid analgesics ,sedatives or anticonvulsants . 3) Neonate with multiple congenital anomalies.

Design outcomes

Primary

Measure	Time frame
PIPP-R SCORETimepoint: Prior to Venipuncture 30 seconds after venipuncture 60 seconds after venipuncture 120 seconds after venipuncture in both arms.	—

Secondary

Measure	Time frame
Any observed adverse effects of Melatonin & sucroseTimepoint: Upto 24 hours after procedure.	—

Countries

India

Contacts

Public ContactDr Sushree Smita Behura

KIMS PBMH Bhubaneswar

sushree.rani87@gmail.com9437084476

Outcome results

None listed

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