NCT04625010 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Cong X
Heel stick test for obtaining blood samples in neonates: both swaddling and heel warming may help, but heel warming appears to provide greater pain reduction. Evid Based Nurs. 2015 Oct;18(4):118. doi: 10.1136/eb-2014-102048. Epub 2015 Apr 16.
Gradin M, Eriksson M, Holmqvist G, Holstein A, Schollin J
Pain reduction at venipuncture in newborns: oral glucose compared with local anesthetic cream. Pediatrics. 2002 Dec;110(6):1053-7.
Harrison D, Reszel J, Bueno M, Sampson M, Shah VS, Taddio A, Larocque C, Turner L
Breastfeeding for procedural pain in infants beyond the neonatal period. Cochrane Database Syst Rev. 2016 Oct 28;10:CD011248. Review.
Karakoç A, Türker F
Effects of white noise and holding on pain perception in newborns. Pain Manag Nurs. 2014 Dec;15(4):864-70. doi: 10.1016/j.pmn.2014.01.002. Epub 2014 Feb 20.
Morrow C, Hidinger A, Wilkinson-Faulk D
Reducing neonatal pain during routine heel lance procedures. MCN Am J Matern Child Nurs. 2010 Nov-Dec;35(6):346-54; quiz 354-6. doi: 10.1097/NMC.0b013e3181f4fc53.
Obeidat HM, Shuriquie MA
Effect of Breast-Feeding and Maternal Holding in Relieving Painful Responses in Full-Term Neonates: A Randomized Clinical Trial. J Perinat Neonatal Nurs. 2015 Jul-Sep;29(3):248-54. doi: 10.1097/JPN.0000000000000121.
Okan F, Ozdil A, Bulbul A, Yapici Z, Nuhoglu A
Analgesic effects of skin-to-skin contact and breastfeeding in procedural pain in healthy term neonates. Ann Trop Paediatr. 2010;30(2):119-28. doi: 10.1179/146532810X12703902516121.

The Effectiveness of Two Different Methods Applied During Heel Blood Collection on Pain Level of Healthy Term Newborns

Details for clinical trial NCT04625010

Clinical trial NCT04625010 - References