40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: Dextrose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Days
Maximum Age: 5 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dextrose gel 40%<br>before heel lance, 2 ml oral dextrose gel 40% was administered, and pain related intensity was evaluated with premature infant pain profile scale | Drug: Dextrose<br>* before heel lance, 2ml oral dextrose gel 25%or 40% was administered, and pain related intensity was evaluated with premature infant pain profile scale<br>|
| Active Comparator: Dextrose gel 25%<br>before heel lance, 2ml oral dextrose gel 25% was administered, and pain related intensity was evaluated with premature infant pain profile scale | Drug: Dextrose<br>* before heel lance, 2ml oral dextrose gel 25%or 40% was administered, and pain related intensity was evaluated with premature infant pain profile scale<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pain reactivity changes were assessed using the Premature Infant Pain Profile-revised (PIPP-R scale) which is composed of three behavioral, two physiological and two contextual pain indicators. Five measurements were undertaken during one routine heel stick which took place 72 hours after birth, on the bed side and coded through direct observation during 15 seconds at 5 different time points: t0: before the heel lance (= baseline 30 minutes without stimuli before heel stick); t1: at the end of the heel lance (after the ending of the squeezing of the heel and successful collection of blood drops); t2: at 1 minute recovery time; t3: at 2 minutes recovery time; t4: at 5' minutes recovery time. | one routine heel stick 72 hours after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Blood glucose levels were measured at two different time points: First glucose level measurement was performed during heel stick by means of the last drop of collected blood Second glucose level measurement was performed 30 minutes after the heel stick. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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procedural pain, 40% Dextrose, heel lance