40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose
NCT ID: NCT02984098
Last Updated: 2016-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2014-09-30
2015-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dextrose gel 40%
before heel lance, 2 ml oral dextrose gel 40% was administered, and pain related intensity was evaluated with premature infant pain profile scale
Dextrose
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%
before heel lance, 2ml oral dextrose gel 25% was administered, and pain related intensity was evaluated with premature infant pain profile scale
Dextrose
before heel lance, 2ml oral dextrose gel 25%or 40% was administered, and pain related intensity was evaluated with premature infant pain profile scale
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dextrose
before heel lance, 2ml oral dextrose gel 25%or 40% was administered, and pain related intensity was evaluated with premature infant pain profile scale
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
3 Days
5 Days
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Targu Mures, Romania
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
LAURA MIHAELA SUCIU, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University of Targu Mures, Romania
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Pediatrics, University of Medicine and Pharmacy Tirgu Mures
Târgu Mureş, , Romania
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
POSDRU/159.5/S/133377
Identifier Type: -
Identifier Source: org_study_id