Pain Clinical Trial
Official title:
Efficacy and Safety of Oral Glucose in Pain Alleviation Among Healthy Term Neonates
Background: It was long believed that newborns could not experience pain. As it is now
documented that newborns have all the necessary systems to perceive pain, pain management can
no longer be ignored.
Pharmacologic agents are not recommended in neonates for pain relief in minor procedures and
still there is debate regarding the efficacy of oral glucose, in different strengths, on
alleviation of pain among neonates.
Aim: The objective of this study is to assess the efficacy and safety oral administration of
glucose, in different concentrations, on pain relief in full term neonates undergoing heel
prick test.
Methods: The investigators will conduct a prospective, randomized, double blind placebo
controlled trial to investigate the effect of glucose solution on alleviating the pain of
heel prick test in 244 healthy full term newborns who will be randomly allocated to one of
three groups: First group will receive 5% glucose, second group will receive 30% glucose and
third group will receive sterile water as a placebo, 2 minutes prior to the procedure.
Specially trained nurses will take turns to carry out blood sampling. Neonatal pain will be
assessed by the Neonatal Infant Pain (NIPS) as well as by duration of crying, changes in
heart rate, respiratory rate and oxygen saturation.
The investigators will conduct a prospective, randomized, double blind, placebo controlled
study of healthy full term newborns delivered by normal vaginal delivery, undergoing heel
prick test. They will be randomized to receive either 5% glucose, 30% glucose or sterile
water as a placebo, 2 minutes prior to the procedure. The investigators will study the
efficacy and safety of oral glucose, in different strengths, compared to placebo (sterile
water) in pain alleviation.
All parents will receive an explanation of the study before participation, and informed
written consent will be signed by the parents for voluntary participation
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