Compare breastmilk and glucose in reducing pain in newborn during needle prick.
- 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
Neonates >37 week gestations who require venipuncture for blood sampling and who are on oral feeds.
- 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
Name Time Method Neonatal Infant Pain Score 2 min after administration of test solution and during venipucture
- Secondary Outcome Measures
Name Time Method crying time Heart rate
Trial Locations
- Locations (1)
Command Hospital Pune - 40
🇮🇳Pune, MAHARASHTRA, India
Command Hospital Pune - 40🇮🇳Pune, MAHARASHTRA, IndiaRaima LukasPrincipal investigator8848858023raimalukas@gmail.com