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

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 4
Locations
Romania
Study Type
Interventional
Intervention
Dextrose
Sponsored by
University of Targu Mures, Romania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring procedural pain, 40% Dextrose, heel lance

Eligibility Criteria

3 Days - 5 Days (Child)All SexesAccepts 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

Sites / Locations

  • Department of Pediatrics, University of Medicine and Pharmacy Tirgu Mures

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dextrose gel 40%

Dextrose gel 25%

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 16, 2016
Last Updated
December 1, 2016
Sponsor
University of Targu Mures, Romania
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1. Study Identification

Unique Protocol Identification Number
NCT02984098
Brief Title
40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose
Acronym
40%D-N-PP
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Targu Mures, Romania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
procedural pain, 40% Dextrose, heel lance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dextrose gel 40%
Arm Type
Experimental
Arm Description
before heel lance, 2 ml oral dextrose gel 40% was administered, and pain related intensity was evaluated with premature infant pain profile scale
Arm Title
Dextrose gel 25%
Arm Type
Active Comparator
Arm Description
before heel lance, 2ml oral dextrose gel 25% was administered, and pain related intensity was evaluated with premature infant pain profile scale
Intervention Type
Drug
Intervention Name(s)
Dextrose
Intervention Description
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 Outcome Measure Information:
Title
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.
Description
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.
Time Frame
one routine heel stick 72 hours after birth
Secondary Outcome Measure Information:
Title
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.
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
5 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LAURA MIHAELA SUCIU, MD,PhD
Organizational Affiliation
University of Targu Mures, Romania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, University of Medicine and Pharmacy Tirgu Mures
City
Tirgu Mures
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
Yes
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40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose

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