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Completed

NCT Number: NCT02984098

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

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 day–5 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Pediatrics, University of Medicine and Pharmacy Tirgu Mures

Târgu Mureş, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dextrose

Drug

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

Primary outcomes

  1. 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.

    Time frame: one 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.

Secondary outcomes

  1. 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.

    Time frame: 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

    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.

Sponsors and collaborators

Lead sponsor

University of Targu Mures, Romania

Other

Registry information

Official study 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

Acronym: 40%D-N-PP

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 6, 2016
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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