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Compare breastmilk and glucose in reducing pain in newborn during needle prick.

Recruiting
Conditions
Newborn babies requiring venipuncture for blood sampling
Registration Number
CTRI/2018/05/014230
Lead Sponsor
Raima Lukas
Brief Summary

A randomised control trial to assess the efficacy of oral 25% dextrose and expressed breast milk  on pain score among neonates undergoing venipuncture. A sample size of 40 will be taken and randomised into two group. The randomisation of the sample will be done by computergenerated chit method. Chits will be numbered and kept in opaque sealed envelope.  Theneonates requiring venipuncture will be taken to a quiet room. It will beensured that time interval between the procedure and previous breast milkintake is at least one hour.  Baselinerespiratory rate of the baby will be recorded. 2ml of test solution will be administered to the baby’s mouth. Allvenipunctures will be done with 23-gauge needle 2 minutes after the testsolution is administered. All venipunctures will be done by same individual whohas adequate experience in neonatal care to minimize variation in pain duringvenipuncture. Thevideo graph of the baby will be taken for later analysis. The response to pain during thisperiod will be recorded and subsequently analysed from the video by a singleobserver. The primary outcomeof the study will be the NIPS score.

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
All
Target Recruitment
40
Inclusion Criteria

Neonates >37 week gestations who require venipuncture for blood sampling and who are on oral feeds.

Exclusion Criteria
  • Neonates who had suffered perinatal asphyxia (Apgar score <5 at 5 minutes), congenital malformations and those on analgesics or sedatives.
  • Neonates with metabolic disorders.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Neonatal Infant Pain Score2 min after administration of test solution and during venipucture
Secondary Outcome Measures
NameTimeMethod
crying timeHeart rate

Trial Locations

Locations (1)

Command Hospital Pune - 40

🇮🇳

Pune, MAHARASHTRA, India

Command Hospital Pune - 40
🇮🇳Pune, MAHARASHTRA, India
Raima Lukas
Principal investigator
8848858023
raimalukas@gmail.com

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