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

Acute Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02984098
• Other study ID #: POSDRU/159.5/S/133377
• Status: Completed
• Phase: Phase 4
• First received: November 16, 2016
• Last updated: December 1, 2016
• Start date: September 2014
• Est. completion date: June 2015

Study information

• Verified date: November 2016
• Source: University of Targu Mures, Romania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 5 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Romania	Department of Pediatrics, University of Medicine and Pharmacy Tirgu Mures	Tirgu Mures

Sponsors (1)

Lead Sponsor	Collaborator
University of Targu Mures, Romania

Country where clinical trial is conducted

Romania, 

References & Publications (23)

Anand KJ, Scalzo FM. Can adverse neonatal experiences alter brain development and subsequent behavior? Biol Neonate. 2000 Feb;77(2):69-82. Review. — View Citation

Anand KJ. Pain, plasticity, and premature birth: a prescription for permanent suffering? Nat Med. 2000 Sep;6(9):971-3. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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, Boëlle PY, Annequin D, Cimerman P, Anand KJ, Bréart 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. — View Citation

Cignacco E, Hamers JP, Stoffel L, van Lingen RA, Schütz N, Müller 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: 2008/33/smw-12147. Erratum in: Swiss Med Wkly. 2009 Jan 10;139(1-2):32. — View Citation

Cignacco E, Hamers JP, van Lingen RA, Zimmermann LJ, Müller 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: 2008/43/smw-12288. — View Citation

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. — View Citation

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. — View Citation

Gaspardo CM, Miyase CI, Chimello JT, Martinez FE, Martins Linhares MB. 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2013;1:CD001069. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one routine heel stick 72 hours after birth	Yes
Secondary	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.	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	Yes

External Links

•   Research Randomizer. Research Randomizer. 2016, cited 2016