drugset / Trial / NCT02984098
40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2014-09
- Primary completion
- 2015-06
- Completion
- 2015-06
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dextrose | Unknown | 25 % | Oral |
| Subject | Dextrose | Unknown | 40 % | Oral |
Indications
No indication recorded.