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Sucrose Practices for Pain in Neonates (SPiN)

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ClinicalTrials.gov Identifier: NCT02134873
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Bonnie Stevens, The Hospital for Sick Children

Brief Summary:
Recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures, such as heel lances, every day. Sucrose (sugar water) has been shown to be effective for reducing pain during invasive procedures and is a standard of care for painful procedures. The purpose of this study is to see what is the least amount of sucrose that can be given to a baby to reduce pain during procedures.

Condition or disease Intervention/treatment Phase
Pain Other: sucrose Not Applicable

Detailed Description:
Infants in the NICU receive an average of 4 - 5 painful procedures daily for diagnostic and therapeutic purposes; less than half receive interventions to manage pain. Both immediate and long term effects of unmanaged pain in these vulnerable infants have been reported, including impaired brain development. To ensure optimal outcomes for hospitalized infants in NICUs, there is a crucial need to minimize procedural pain and its associated consequences. Multiple clinical trials have identified sucrose as an effective strategy for reducing procedural pain in infants. Despite its inclusion in neonatal pain guidelines, standards, and consensus statements sucrose has been inconsistently used. The under-utilization of sucrose may be explained by knowledge gaps in relation to the minimally effective dose and the influence of concurrent opioid analgesia, as well as the short and long-term effects of repeated administration. Once infants in the NICU are determined to be eligible for the study and parents consent, infants will be randomized to one of 3 dose of sucrose and their pain will be assessed using a validated pain assessment measure.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sucrose Practices for Pain in Neonates: A Program of Research: Part A (Trial 1 and 2): Determining the Minimally Effective Dose of Sucrose for Procedural Pain in Infants
Study Start Date : July 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

Arm Intervention/treatment
Active Comparator: 0.1ml 24% sucrose concurrent opioids
0.1ml 24% sucrose concurrent opioids
Other: sucrose
Sucrose will be administered by a research nurse experienced in neonatal intensive care using a standardized procedure and timing consistent with policies in the participating units, including: (a) administering sucrose 2 minutes prior to the heel lance to ensure peak effects; (b) giving the total volume of sucrose drop by drop via syringe on the anterior surface of the tongue, as tolerated, over a period of up to 1 minute to allow for individual infant swallowing rates and to ensure analgesic effects are sustained during the heel lance procedure; and (c) offering a pacifier for non-nutritive sucking (NNS) immediately following sucrose administration.
Other Name: Brand name = Tootsweet

Active Comparator: 0.5ml 24% sucrose concurrent opioids
0.5ml 24% sucrose concurrent opioids
Other: sucrose
Sucrose will be administered by a research nurse experienced in neonatal intensive care using a standardized procedure and timing consistent with policies in the participating units, including: (a) administering sucrose 2 minutes prior to the heel lance to ensure peak effects; (b) giving the total volume of sucrose drop by drop via syringe on the anterior surface of the tongue, as tolerated, over a period of up to 1 minute to allow for individual infant swallowing rates and to ensure analgesic effects are sustained during the heel lance procedure; and (c) offering a pacifier for non-nutritive sucking (NNS) immediately following sucrose administration.
Other Name: Brand name = Tootsweet

Active Comparator: 1.0ml 24% sucrose concurrent opioids
1.0ml 24% sucrose concurrent opioids
Other: sucrose
Sucrose will be administered by a research nurse experienced in neonatal intensive care using a standardized procedure and timing consistent with policies in the participating units, including: (a) administering sucrose 2 minutes prior to the heel lance to ensure peak effects; (b) giving the total volume of sucrose drop by drop via syringe on the anterior surface of the tongue, as tolerated, over a period of up to 1 minute to allow for individual infant swallowing rates and to ensure analgesic effects are sustained during the heel lance procedure; and (c) offering a pacifier for non-nutritive sucking (NNS) immediately following sucrose administration.
Other Name: Brand name = Tootsweet

Active Comparator: 0.1ml 24% sucrose no opioids
0.1ml 24% sucrose no opioids
Other: sucrose
Sucrose will be administered by a research nurse experienced in neonatal intensive care using a standardized procedure and timing consistent with policies in the participating units, including: (a) administering sucrose 2 minutes prior to the heel lance to ensure peak effects; (b) giving the total volume of sucrose drop by drop via syringe on the anterior surface of the tongue, as tolerated, over a period of up to 1 minute to allow for individual infant swallowing rates and to ensure analgesic effects are sustained during the heel lance procedure; and (c) offering a pacifier for non-nutritive sucking (NNS) immediately following sucrose administration.
Other Name: Brand name = Tootsweet

Active Comparator: 0.5ml 24% sucrose no opioids
0.5ml 24% sucrose no opioids
Other: sucrose
Sucrose will be administered by a research nurse experienced in neonatal intensive care using a standardized procedure and timing consistent with policies in the participating units, including: (a) administering sucrose 2 minutes prior to the heel lance to ensure peak effects; (b) giving the total volume of sucrose drop by drop via syringe on the anterior surface of the tongue, as tolerated, over a period of up to 1 minute to allow for individual infant swallowing rates and to ensure analgesic effects are sustained during the heel lance procedure; and (c) offering a pacifier for non-nutritive sucking (NNS) immediately following sucrose administration.
Other Name: Brand name = Tootsweet

Active Comparator: 1.0ml 24% sucrose no opioids
1.0ml 24% sucrose no opioids
Other: sucrose
Sucrose will be administered by a research nurse experienced in neonatal intensive care using a standardized procedure and timing consistent with policies in the participating units, including: (a) administering sucrose 2 minutes prior to the heel lance to ensure peak effects; (b) giving the total volume of sucrose drop by drop via syringe on the anterior surface of the tongue, as tolerated, over a period of up to 1 minute to allow for individual infant swallowing rates and to ensure analgesic effects are sustained during the heel lance procedure; and (c) offering a pacifier for non-nutritive sucking (NNS) immediately following sucrose administration.
Other Name: Brand name = Tootsweet




Primary Outcome Measures :
  1. The primary outcome is pain intensity measured using the Premature Infant Pain Profile-Revised (PIPP-R). [ Time Frame: Change from baseline 30 seconds post painful procedure ]
    Premature Infant Pain Profile- Revised is a validated pain measure to assess infant pain


Secondary Outcome Measures :
  1. The secondary outcome is pain intensity measured using the Premature Infant Pain Profile-Revised (PIPP-R). [ Time Frame: Change from baseline 60 seconds post painful procedure ]
    Premature Infant Pain Profile-Revised is a validated pain measure to assess infant pain

  2. The secondary outcome is frequency of occurrence of adverse events. [ Time Frame: Starting from the administration of sucrose until the end of the procedure (procedure could last on average 6 minutes) or longer if indicated. ]
    The potential adverse events include: heart rate >240 beats/minute or <80 beats/minute for >20 seconds, oxygen saturation <80% for > 20 seconds, no spontaneous respirations for > 20 seconds, and choking or gagging.



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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants 24 to 42 weeks gestational age (GA) at birth, admitted to the Neonatal Intensive Care Unit (NICU), and scheduled to receive a heel lance will be eligible. Parents will be approached for participation within the first 2 weeks of the infant's life. Infants will be eligible for Trial 1, the non-opioid trial, if they have not received any opioids within 24 hours prior to the heel lance. Infants will be eligible for Trial 2, the opioid trial, if they are currently receiving an opioid infusion. Furthermore, observation of the procedures will be timed to ensure that no additional sucrose doses are provided within the previous 4 hours.

Exclusion Criteria:

  • Infants will be excluded if they have a contraindication for sucrose administration (e.g., unable to swallow, pharmacologically muscle relaxed, or heavily sedated) due to safety concerns and/or inability to assess pain accurately (e.g., unable to clearly view the infant's face).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134873


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Bonnie Stevens, RN, PhD The Hospital for Sick Children
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bonnie Stevens, Dr. Bonnie Stevens, RN, PhD, Signy Hildur Eaton Chair in Paediatric Nursing Research, Associate Chief of Nursing Research, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02134873    
Other Study ID Numbers: 1000038052
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Keywords provided by Bonnie Stevens, The Hospital for Sick Children:
Pain
Pain management
Hospitalized
Infants
Sucrose