PainSPiNNCT02134873
Sucrose Practices for Pain in Neonates
A study testing sucrose in people with Pain, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 2 weeks
- Conditions the study is for
- Pain
- What is being tested?
- sucrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 2 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pain
- Being tested
- sucrose
- Keywords
- Pain, Pain management, Hospitalized, Infants, Sucrose
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sucroseOther
Also called Brand name = Tootsweet
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.
| Study group | Role | What they receive |
|---|---|---|
| 0.1ml 24% sucrose concurrent opioids | Active comparator | 0.1ml 24% sucrose concurrent opioids Receives: Other: sucrose |
| 0.5ml 24% sucrose concurrent opioids | Active comparator | 0.5ml 24% sucrose concurrent opioids Receives: Other: sucrose |
| 1.0ml 24% sucrose concurrent opioids | Active comparator | 1.0ml 24% sucrose concurrent opioids Receives: Other: sucrose |
| 0.1ml 24% sucrose no opioids | Active comparator | 0.1ml 24% sucrose no opioids Receives: Other: sucrose |
| 0.5ml 24% sucrose no opioids | Active comparator | 0.5ml 24% sucrose no opioids Receives: Other: sucrose |
| 1.0ml 24% sucrose no opioids | Active comparator | 1.0ml 24% sucrose no opioids Receives: Other: sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is pain intensity measured using the Premature Infant Pain Profile-Revised (PIPP-R).
Premature Infant Pain Profile- Revised is a validated pain measure to assess infant pain
Measured: Change from baseline 30 seconds post painful procedure
Secondary outcomes (2)
The secondary outcome is pain intensity measured using the Premature Infant Pain Profile-Revised (PIPP-R).
Premature Infant Pain Profile-Revised is a validated pain measure to assess infant pain
Measured: Change from baseline 60 seconds post painful procedure
The secondary outcome is frequency of occurrence of adverse events.
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.
Measured: Starting from the administration of sucrose until the end of the procedure (procedure could last on average 6 minutes) or longer if indicated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startJul 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bonnie Stevens, The Hospital for Sick Children
- Investigators
- Bonnie Stevens, RN, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134873
- Sponsor's protocol ID
- 1000038052
- Acronym
- SPiN
- Status last verified
- May 2015
- First submitted
- 5 May 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stevens B, Yamada J, Campbell-Yeo M, Gibbins S, Harrison D, Dionne K, Taddio A, McNair C, Willan A, Ballantyne M, Widger K, Sidani S, Estabrooks C, Synnes A, Squires J, Victor C, Riahi S. The minimally effective dose of sucrose for procedural pain relief in neonates: a randomized controlled trial. BMC Pediatr. 2018 Feb 23;18(1):85. doi: 10.1186/s12887-018-1026-x.
PubMed 29475433
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02134873
- Acronym / sponsor ID
- SPiN / 1000038052
- Conditions
- Pain
- Keywords
- Pain, Pain management, Hospitalized, Infants, Sucrose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 0.1ml 24% sucrose concurrent opioids | Active comparator | Other: sucrose0.1ml 24% sucrose concurrent opioids |
| 0.5ml 24% sucrose concurrent opioids | Active comparator | Other: sucrose0.5ml 24% sucrose concurrent opioids |
| 1.0ml 24% sucrose concurrent opioids | Active comparator | Other: sucrose1.0ml 24% sucrose concurrent opioids |
| 0.1ml 24% sucrose no opioids | Active comparator | Other: sucrose0.1ml 24% sucrose no opioids |
| 0.5ml 24% sucrose no opioids | Active comparator | Other: sucrose0.5ml 24% sucrose no opioids |
| 1.0ml 24% sucrose no opioids | Active comparator | Other: sucrose1.0ml 24% sucrose no opioids |
Who may qualify
- Ages
- 1 day to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sucroseAlso: Brand name = TootsweetSucrose 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 | 0.1ml 24% sucrose concurrent opioids, 0.1ml 24% sucrose no opioids, 0.5ml 24% sucrose concurrent opioids, 0.5ml 24% sucrose no opioids, 1.0ml 24% sucrose concurrent opioids, 1.0ml 24% sucrose no opioids |
Primary outcome
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
2 secondary outcomes
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Derived from this study: PubMed 29475433Stevens B, Yamada J, Campbell-Yeo M, Gibbins S, Harrison D, Dionne K, Taddio A, McNair C, Willan A, Ballantyne M, Widger K, Sidani S, Estabrooks C, Synnes A, Squires J, Victor C, Riahi S. The minimally effective dose of sucrose for procedural pain relief in neonates: a randomized controlled trial. BMC Pediatr. 2018 Feb 23;18(1):85. doi: 10.1186/s12887-018-1026-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonnie Stevens, RN, PhD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sucrose in people with Pain, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02134873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.