<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02984098</url>
  </required_header>
  <id_info>
    <org_study_id>POSDRU/159.5/S/133377</org_study_id>
    <nct_id>NCT02984098</nct_id>
  </id_info>
  <brief_title>40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose</brief_title>
  <acronym>40%D-N-PP</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Targu Mures, Romania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Targu Mures, Romania</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to evaluate the safe of 40% Dextrose oral administration on blood&#xD;
      glucose concentration and to reducing of pain before painful procedures on healthy term&#xD;
      neonate 72 hours aged.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the study period around 2000 term neonates were born in the university affiliated&#xD;
      hospital. Five to 7 term neonates were assessed weekly by the principal investigator (PI) for&#xD;
      study eligibility. The parents of neonates who met the inclusion criteria received&#xD;
      information about the study after which they were invited to participate. Written informed&#xD;
      consent from parent was obtained. The PI entered data into the online Research Randomizer&#xD;
      which provided a randomization number corresponding to a numbered treatment pack containing&#xD;
      two syringes, each containing 2ml of an identical and therefore blinded liquid. Study&#xD;
      investigators, clinical staff, parents and monitors remained blinded to treatment allocation&#xD;
      until data analysis was completed. To ensure standardization the included term infants were&#xD;
      not breastfeed 30' prior to the heel stick and a standardized heel lance was used.Each infant&#xD;
      was taken to a separate room with the mother by the assigned nurse to provide a quite&#xD;
      environment. All infants were awake at the time of the procedure. Their clothes were removed&#xD;
      and wet diapers were changed. In both groups, the infants were placed in a supine position on&#xD;
      a changing table. Dextrose administration and the heel stick were undertaken by an&#xD;
      experienced staff neonatal nurse. The heel was warmed with a warm wet towel up 2' minutes&#xD;
      before the procedure. The heel was disinfected shortly before the procedure started.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>one routine heel stick 72 hours after birth</time_frame>
    <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:&#xD;
t0: before the heel lance (= baseline 30 minutes without stimuli before heel stick);&#xD;
t1: at the end of the heel lance (after the ending of the squeezing of the heel and successful collection of blood drops);&#xD;
t2: at 1 minute recovery time;&#xD;
t3: at 2 minutes recovery time;&#xD;
t4: at 5' minutes recovery time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <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</time_frame>
    <description>Blood glucose levels were measured at two different time points:&#xD;
First glucose level measurement was performed during heel stick by means of the last drop of collected blood&#xD;
Second glucose level measurement was performed 30 minutes after the heel stick.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Acute Pain</condition>
  <arm_group>
    <arm_group_label>Dextrose gel 40%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>before heel lance, 2 ml oral dextrose gel 40% was administered, and pain related intensity was evaluated with premature infant pain profile scale</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dextrose gel 25%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>before heel lance, 2ml oral dextrose gel 25% was administered, and pain related intensity was evaluated with premature infant pain profile scale</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dextrose</intervention_name>
    <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</description>
    <arm_group_label>Dextrose gel 25%</arm_group_label>
    <arm_group_label>Dextrose gel 40%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  were born at ≥ 37 weeks of gestation were&#xD;
&#xD;
          -  APGAR score of ≥ 7 five minutes after birth&#xD;
&#xD;
          -  had a postnatal age of ≥ 72 hours&#xD;
&#xD;
          -  were breastfed (but not 30' prior to the testing HS)&#xD;
&#xD;
          -  were undergoing a routine heel stick for metabolic screening between the third and&#xD;
             fifth postnatal day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any kind of medical instabilities needing a transfer to the neonatal intensive care&#xD;
             unit (NICU)&#xD;
&#xD;
          -  severe intrapartum asphyxia defined as a 5' Apgar score less than 3&#xD;
&#xD;
          -  parenteral nutrition and the presence of neurological symptoms&#xD;
&#xD;
          -  congenital anomalies&#xD;
&#xD;
          -  other conditions requiring treatment for hypo- or hyperglycemia&#xD;
&#xD;
          -  those in which the heel lance procedure failed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Days</minimum_age>
    <maximum_age>5 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>LAURA MIHAELA SUCIU, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Targu Mures, Romania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Pediatrics, University of Medicine and Pharmacy Tirgu Mures</name>
      <address>
        <city>Tirgu Mures</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <reference>
    <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, 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.</citation>
    <PMID>18594041</PMID>
  </reference>
  <reference>
    <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. Epub 2011 Apr 4.</citation>
    <PMID>21464171</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19005869</PMID>
  </reference>
  <reference>
    <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. Epub 2014 Feb 4.</citation>
    <PMID>24503902</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10657682</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10973310</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20425200</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22751876</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20091512</PMID>
  </reference>
  <reference>
    <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. Epub 2016 Jan 25.</citation>
    <PMID>26810788</PMID>
  </reference>
  <reference>
    <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. Epub 2012 Oct 8.</citation>
    <PMID>23045554</PMID>
  </reference>
  <reference>
    <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. doi: 10.1155/2013/956549.</citation>
    <PMID>23748256</PMID>
  </reference>
  <reference>
    <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. Epub 2010 Oct 11.</citation>
    <PMID>20937658</PMID>
  </reference>
  <reference>
    <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. doi: 10.1097/01.ajp.0000149802.46864.e2.</citation>
    <PMID>16215340</PMID>
  </reference>
  <reference>
    <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. doi: 10.1542/peds.2006-0913R.</citation>
    <PMID>17079623</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17854995</PMID>
  </reference>
  <reference>
    <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. doi: 10.1542/peds.2006-3001. No abstract available.</citation>
    <PMID>17200300</PMID>
  </reference>
  <reference>
    <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. Epub 2014 Dec 23.</citation>
    <PMID>25534000</PMID>
  </reference>
  <reference>
    <citation>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. Erratum In: Swiss Med Wkly. 2009 Jan 10;139(1-2):32.</citation>
    <PMID>18726734</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18762508</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20332509</PMID>
  </reference>
  <reference>
    <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. Epub 2014 Feb 1.</citation>
    <PMID>24491511</PMID>
  </reference>
  <reference>
    <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. doi: 10.1097/00002508-199912000-00006.</citation>
    <PMID>10617258</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>procedural pain, 40% Dextrose, heel lance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02984098
org study id: POSDRU/159.5/S/133377
nct id: NCT02984098
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: 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.
time frame: one 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.
measure: 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.
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
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.
arm group label: Dextrose gel 40%
arm group type: Experimental
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 group label: Dextrose gel 25%
arm group type: Active Comparator
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: Dextrose
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
arm group label: Dextrose gel 25%
arm group label: Dextrose gel 40%
criteria: 
gender: All
minimum age: 3 Days
maximum age: 5 Days
healthy volunteers: Accepts Healthy Volunteers
last name: LAURA MIHAELA SUCIU, MD,PhD
role: Principal Investigator
affiliation: University of Targu Mures, Romania
facility: 
country: Romania
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, 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: 18594041
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. Epub 2011 Apr 4.
PMID: 21464171
citation: 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: 19005869
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. Epub 2014 Feb 4.
PMID: 24503902
citation: 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: 10657682
citation: 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: 10973310
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.
PMID: 20425200
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.
PMID: 22751876
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.
PMID: 20091512
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. Epub 2016 Jan 25.
PMID: 26810788
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. Epub 2012 Oct 8.
PMID: 23045554
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. doi: 10.1155/2013/956549.
PMID: 23748256
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. Epub 2010 Oct 11.
PMID: 20937658
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. doi: 10.1097/01.ajp.0000149802.46864.e2.
PMID: 16215340
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. doi: 10.1542/peds.2006-0913R.
PMID: 17079623
citation: 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: 17854995
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. doi: 10.1542/peds.2006-3001. No abstract available.
PMID: 17200300
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responsible party type: Sponsor
mesh term: Acute Pain
sharing ipd: Yes