Clinical trial NCT02984098: 40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose
Official title: 40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose But Not Sufficiently Reliefs Acute Pain in Term Neonates: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pain
Keywords: procedural pain, 40% Dextrose, heel lance
Lead sponsor: University of Targu Mures, Romania
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the safe of 40% Dextrose oral administration on blood glucose concentration and to reducing of pain before painful procedures on healthy term neonate 72 hours aged.

Detailed description: During the study period around 2000 term neonates were born in the university affiliated hospital. Five to 7 term neonates were assessed weekly by the principal investigator (PI) for study eligibility. The parents of neonates who met the inclusion criteria received information about the study after which they were invited to participate. Written informed consent from parent was obtained. The PI entered data into the online Research Randomizer which provided a randomization number corresponding to a numbered treatment pack containing two syringes, each containing 2ml of an identical and therefore blinded liquid. Study investigators, clinical staff, parents and monitors remained blinded to treatment allocation until data analysis was completed. To ensure standardization the included term infants were not breastfeed 30' prior to the heel stick and a standardized heel lance was used.Each infant was taken to a separate room with the mother by the assigned nurse to provide a quite environment. All infants were awake at the time of the procedure. Their clothes were removed and wet diapers were changed. In both groups, the infants were placed in a supine position on a changing table. Dextrose administration and the heel stick were undertaken by an experienced staff neonatal nurse. The heel was warmed with a warm wet towel up 2' minutes before the procedure. The heel was disinfected shortly before the procedure started.

Eligibility criteria: Inclusion Criteria:

* were born at ≥ 37 weeks of gestation were
* APGAR score of ≥ 7 five minutes after birth
* had a postnatal age of ≥ 72 hours
* were breastfed (but not 30' prior to the testing HS)
* were undergoing a routine heel stick for metabolic screening between the third and fifth postnatal day

Exclusion Criteria:

* any kind of medical instabilities needing a transfer to the neonatal intensive care unit (NICU)
* severe intrapartum asphyxia defined as a 5' Apgar score less than 3
* parenteral nutrition and the presence of neurological symptoms
* congenital anomalies
* other conditions requiring treatment for hypo- or hyperglycemia
* those in which the heel lance procedure failed

Primary outcomes:
measure: Pain reactivity changes after orally administered 0.5 ml/ kg body 40% dextrose gel or 25% dextrose as procedural pain relief in term neonates requiring a routine heel stick 72 hours after birth.
timeFrame: one routine heel stick 72 hours after birth
Secondary outcomes:
measure: Blood glucose levels changes after orally administered 0.5 ml/kg body 40% dextrose gel or 25% dextrose as procedural pain relief in term neonates requiring a routine heel stick 72 hours after birth.
timeFrame: one routine heel stick 72 hours after birth and at 30 minutes after orally 0.5 ml/kg body 40% dextrose gel or 25% dextrose
Other outcomes:
Locations:
city: Tirgu Mures
country: Romania
facility: Department of Pediatrics, University of Medicine and Pharmacy Tirgu Mures
Study officials:
affiliation: University of Targu Mures, Romania
name: LAURA MIHAELA SUCIU, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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