Sucrose Practices for Pain in Neonates (SPiN)

May 26, 2015 updated by: Bonnie Stevens, The Hospital for Sick Children

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
291

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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 Names:
  • Brand name = Tootsweet
Active Comparator: 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 Names:
  • Brand name = Tootsweet
Active Comparator: 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 Names:
  • Brand name = Tootsweet
Active Comparator: 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 Names:
  • Brand name = Tootsweet
Active Comparator: 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 Names:
  • Brand name = Tootsweet
Active Comparator: 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 Names:
  • Brand name = Tootsweet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline 30 seconds post painful procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline 60 seconds post painful procedure
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.
Starting from the administration of sucrose until the end of the procedure (procedure could last on average 6 minutes) or longer if indicated.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bonnie Stevens, RN, PhD, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1000038052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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