Trial | NCT02984098  Report issue

Title

40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose
40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose But Not Sufficiently Reliefs Acute Pain in Term Neonates: A Randomized Controlled Trial

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    200
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.
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.
Study Started
Sep 30
2014
Primary Completion
Jun 30
2015
Study Completion
Jun 30
2015
Last Update
Dec 06
2016
Estimate

Drug Dextrose

before heel lance, 2ml oral dextrose gel 25%or 40% was administered, and pain related intensity was evaluated with premature infant pain profile scale

Dextrose gel 40% Experimental

before heel lance, 2 ml oral dextrose gel 40% was administered, and pain related intensity was evaluated with premature infant pain profile scale

Dextrose gel 25% Active Comparator

before heel lance, 2ml oral dextrose gel 25% was administered, and pain related intensity was evaluated with premature infant pain profile scale

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
No Results Posted