A study in which 2 different sweet solutions, 24 % sucrose and 25 % dextrose will be compared for their effectivenss in decreasing pain sensation when given orally before blood testing in preterm babies

25% DEXTROSE VS 24% SUCROSE FOR PROCEDURAL PAIN CONTROL IN PRETERM NEONATES (28 WEEKS-35 6/7 WEEKS): A RANDOMIZED CONTROLLED NON-INFERIORITY TRIAL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/02/017383

Enrollment

Registered

2019-02-01

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

None listed

Interventions

Intervention1: 24% sucrose: oral 24 % sucrose 0.5 ml given 2 minutes prior to heel lancing procedure in preterm neonates (28 to 35 6/7 weeks) Control Intervention1: 25% Dextrose: oral 25% Dextrose 0.5

Eligibility

Inclusion criteria

Inclusion criteria: 1. Gestational age 280/7 to 356/7 weeks with 2. Post-natal age more than 12 hours with 3. Requirement of a purposeful heel lancing

Exclusion criteria

Exclusion criteria: 1. Perinatal asphyxia (5 mins APGAR score 2. Grade 3 and grade 4 IVH 3. Post-surgical patients 4. Birth trauma- facial contusion, sub-galeal or cephal-hematoma, any fractures 5. Major congenital malformations 6. Neonates on invasive mechanical ventilation 7. Neonates on inotropic support 8. Neurological abnormality or seizures since birth 9. Received sedatives/analgesics/paralytics in the past 48 hours 10. Maternal history of substance abuse 11. Born to mothers who have received opiates or general anesthesia during labour

Design outcomes

Primary

Measure	Time frame
4.1.1 To determine the efficacy of oral 25 % dextrose as compared with 24 % sucrose for procedural pain in preterm neonates during heel lancing as assessed by PIPP scores at 30 seconds post procedure.Timepoint: 30 seconds	—

Secondary

Measure	Time frame
4.2.1 To compare PIPP score among the two groups at 1 minute and 2 minutes post procedure. 4.2.2 To compare PIPP and PIPP-R scores in preterm neonates (28-35 6/7 weeks), receiving analgesia for procedural pain at various intervals (30s, 60s and 2 mins). 4.2.3 To compare any immediate adverse events with the use of 25 % dextrose and 24 % sucrose Timepoint: 30 seconds, 60 seconds and 2 minutes	—

Countries

India

Contacts

Public ContactS ROHIT

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR

neerajpgi@yahoo.co.in8003996908

Outcome results