40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose (40%D-N-PP)

University of Târgu Mureș

Status and phase: Completed; Phase 4

Conditions: Acute Pain

Treatments: Drug: Dextrose

Study type: Interventional

Funder types: Other

Identifiers

NCT02984098

POSDRU/159.5/S/133377

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 3 to 5 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Dextrose gel 40%

Experimental group

Description:

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

Treatment:

Drug: Dextrose

Dextrose gel 25%

Active Comparator group

Description:

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

Treatment:

Drug: Dextrose