NCT02984098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
Last Updated

December 6, 2016

Status Verified

November 1, 2016

Enrollment Period

9 months

First QC Date

November 16, 2016

Last Update Submit

December 1, 2016

Conditions

Acute Pain

Keywords

procedural pain, 40% Dextrose, heel lance

Outcome Measures

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.

    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: 1. t0: before the heel lance (= baseline 30 minutes without stimuli before heel stick); 2. t1: at the end of the heel lance (after the ending of the squeezing of the heel and successful collection of blood drops); 3. t2: at 1 minute recovery time; 4. t3: at 2 minutes recovery time; 5. t4: at 5' minutes recovery time.

    one routine heel stick 72 hours after birth

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.

    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

Study Arms (2)

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

Drug: Dextrose

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

Drug: Dextrose

Interventions

DextroseDRUG

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 25%Dextrose gel 40%

Eligibility Criteria

Age3 Days - 5 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, University of Medicine and Pharmacy Tirgu Mures

TĂ¢rgu MureÅŸ, Romania

Location

Related Publications (23)

  • Carbajal R, Rousset A, Danan C, Coquery S, Nolent P, Ducrocq S, Saizou C, Lapillonne A, Granier M, Durand P, Lenclen R, Coursol A, Hubert P, de Saint Blanquat L, Boelle PY, Annequin D, Cimerman P, Anand KJ, Breart G. Epidemiology and treatment of painful procedures in neonates in intensive care units. JAMA. 2008 Jul 2;300(1):60-70. doi: 10.1001/jama.300.1.60.

    PMID: 18594041BACKGROUND

  • Stevens BJ, Abbott LK, Yamada J, Harrison D, Stinson J, Taddio A, Barwick M, Latimer M, Scott SD, Rashotte J, Campbell F, Finley GA; CIHR Team in Children's Pain. Epidemiology and management of painful procedures in children in Canadian hospitals. CMAJ. 2011 Apr 19;183(7):E403-10. doi: 10.1503/cmaj.101341. Epub 2011 Apr 4.

    PMID: 21464171BACKGROUND

  • Cignacco E, Hamers JP, van Lingen RA, Zimmermann LJ, Muller R, Gessler P, Nelle M. Pain relief in ventilated preterms during endotracheal suctioning: a randomized controlled trial. Swiss Med Wkly. 2008 Nov 1;138(43-44):635-45. doi: 10.4414/smw.2008.12288.

    PMID: 19005869BACKGROUND

  • Roofthooft DW, Simons SH, Anand KJ, Tibboel D, van Dijk M. Eight years later, are we still hurting newborn infants? Neonatology. 2014;105(3):218-26. doi: 10.1159/000357207. Epub 2014 Feb 4.

    PMID: 24503902BACKGROUND

  • Anand KJ, Scalzo FM. Can adverse neonatal experiences alter brain development and subsequent behavior? Biol Neonate. 2000 Feb;77(2):69-82. doi: 10.1159/000014197.

    PMID: 10657682BACKGROUND

  • Anand KJ. Pain, plasticity, and premature birth: a prescription for permanent suffering? Nat Med. 2000 Sep;6(9):971-3. doi: 10.1038/79658. No abstract available.

    PMID: 10973310BACKGROUND

  • Harrison D, Yamada J, Stevens B. Strategies for the prevention and management of neonatal and infant pain. Curr Pain Headache Rep. 2010 Apr;14(2):113-23. doi: 10.1007/s11916-009-0091-0.

    PMID: 20425200BACKGROUND

  • Wilkinson DJ, Savulescu J, Slater R. Sugaring the pill: ethics and uncertainties in the use of sucrose for newborn infants. Arch Pediatr Adolesc Med. 2012 Jul 1;166(7):629-33. doi: 10.1001/archpediatrics.2012.352.

    PMID: 22751876BACKGROUND

  • Stevens B, Yamada J, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD001069. doi: 10.1002/14651858.CD001069.pub3.

    PMID: 20091512BACKGROUND

  • COMMITTEE ON FETUS AND NEWBORN and SECTION ON ANESTHESIOLOGY AND PAIN MEDICINE. Prevention and Management of Procedural Pain in the Neonate: An Update. Pediatrics. 2016 Feb;137(2):e20154271. doi: 10.1542/peds.2015-4271. Epub 2016 Jan 25.

    PMID: 26810788BACKGROUND

  • Harrison D, Beggs S, Stevens B. Sucrose for procedural pain management in infants. Pediatrics. 2012 Nov;130(5):918-25. doi: 10.1542/peds.2011-3848. Epub 2012 Oct 8.

    PMID: 23045554BACKGROUND

  • Bueno M, Yamada J, Harrison D, Khan S, Ohlsson A, Adams-Webber T, Beyene J, Stevens B. A systematic review and meta-analyses of nonsucrose sweet solutions for pain relief in neonates. Pain Res Manag. 2013 May-Jun;18(3):153-61. doi: 10.1155/2013/956549.

    PMID: 23748256BACKGROUND

  • Harrison D, Bueno M, Yamada J, Adams-Webber T, Stevens B. Analgesic effects of sweet-tasting solutions for infants: current state of equipoise. Pediatrics. 2010 Nov;126(5):894-902. doi: 10.1542/peds.2010-1593. Epub 2010 Oct 11.

    PMID: 20937658BACKGROUND

  • Stevens B, Yamada J, Beyene J, Gibbins S, Petryshen P, Stinson J, Narciso J. Consistent management of repeated procedural pain with sucrose in preterm neonates: Is it effective and safe for repeated use over time? Clin J Pain. 2005 Nov-Dec;21(6):543-8. doi: 10.1097/01.ajp.0000149802.46864.e2.

    PMID: 16215340BACKGROUND

  • Lefrak L, Burch K, Caravantes R, Knoerlein K, DeNolf N, Duncan J, Hampton F, Johnston C, Lockey D, Martin-Walters C, McLendon D, Porter M, Richardson C, Robinson C, Toczylowski K. Sucrose analgesia: identifying potentially better practices. Pediatrics. 2006 Nov;118 Suppl 2:S197-202. doi: 10.1542/peds.2006-0913R.

    PMID: 17079623BACKGROUND

  • Gaspardo CM, Miyase CI, Chimello JT, Martinez FE, Linhares MBM. Is pain relief equally efficacious and free of side effects with repeated doses of oral sucrose in preterm neonates? Pain. 2008 Jul;137(1):16-25. doi: 10.1016/j.pain.2007.07.032. Epub 2007 Sep 12.

    PMID: 17854995BACKGROUND

  • Johnston CC, Filion F, Snider L, Limperopoulos C, Majnemer A, Pelausa E, Cake H, Stone S, Sherrard A, Boyer K. How much sucrose is too much sucrose? Pediatrics. 2007 Jan;119(1):226. doi: 10.1542/peds.2006-3001. No abstract available.

    PMID: 17200300BACKGROUND

  • Bellieni CV, Stazzoni G, Tei M, Alagna MG, Iacoponi F, Cornacchione S, Bertrando S, Buonocore G. How painful is a heelprick or a venipuncture in a newborn? J Matern Fetal Neonatal Med. 2016;29(2):202-6. doi: 10.3109/14767058.2014.992334. Epub 2014 Dec 23.

    PMID: 25534000BACKGROUND

  • Cignacco E, Hamers JP, Stoffel L, van Lingen RA, Schutz N, Muller R, Zimmermann LJ, Nelle M. Routine procedures in NICUs: factors influencing pain assessment and ranking by pain intensity. Swiss Med Wkly. 2008 Aug 23;138(33-34):484-91. doi: 10.4414/smw.2008.12147.

    PMID: 18726734BACKGROUND

  • Codipietro L, Ceccarelli M, Ponzone A. Breastfeeding or oral sucrose solution in term neonates receiving heel lance: a randomized, controlled trial. Pediatrics. 2008 Sep;122(3):e716-21. doi: 10.1542/peds.2008-0221.

    PMID: 18762508BACKGROUND

  • Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.

    PMID: 20332509BACKGROUND

  • Gibbins S, Stevens BJ, Yamada J, Dionne K, Campbell-Yeo M, Lee G, Caddell K, Johnston C, Taddio A. Validation of the Premature Infant Pain Profile-Revised (PIPP-R). Early Hum Dev. 2014 Apr;90(4):189-93. doi: 10.1016/j.earlhumdev.2014.01.005. Epub 2014 Feb 1.

    PMID: 24491511BACKGROUND

  • Ballantyne M, Stevens B, McAllister M, Dionne K, Jack A. Validation of the premature infant pain profile in the clinical setting. Clin J Pain. 1999 Dec;15(4):297-303. doi: 10.1097/00002508-199912000-00006.

    PMID: 10617258BACKGROUND

MeSH Terms

Conditions

Acute PainPain, Procedural

Interventions

Glucose

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • LAURA MIHAELA SUCIU, MD,PhD

    University of Targu Mures, Romania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2016

First Posted

December 6, 2016

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 6, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Locations

RO(1)