PainNCT02344368
The Effect of Sucrose on Pain Relief During Venous Blood Sampling in Preterm Infants
A study testing 0.2 ml sucrose 25% and 0.5 ml sucrose 25% in people with Pain, run by Norwegian University of Science and Technology at 2 sites in 2 countries.
Trial summary
Despite the fact that oral sucrose is the most frequently studied non-pharmacological intervention for procedural pain relief in infants, there is a paucity of data on the minimal effective dose. Read more about this study
- Who is it for?
- Ages Up to 8 weeks
- Conditions the study is for
- Pain
- What is being tested?
- 0.2 ml sucrose 25% and 0.5 ml sucrose 25%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2015to Jun 2016
- 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 Up to 8 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- born preterm
- more than 1000 gram
Who cannot join
- severe intraventricular hemorrhage
- cerebral malformations
- other malformations requiring surgery
- medication that may impair pain expression (opioids, paracetamol, sedatives)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
South Africa1 site
Lower Umfolozi Rigional War Memorial Hospital, NICU
Empangeni
About this study
Official title: The Effect of Sucrose on Pain Relief During Venous Blood Sampling in Preterm Infants: a Comparison of Two Different Doses
Despite the fact that oral sucrose is the most frequently studied non-pharmacological intervention for procedural pain relief in infants, there is a paucity of data on the minimal effective dose. The aim of this study is to find the minimal effective dose of sucrose to reduce pain during a single venous blood sampling procedure.
- Conditions
- Pain
- Being tested
- 0.2 ml sucrose 25%, 0.5 ml sucrose 25%
- Keywords
- Sucrose, Anesthesia, Blood specimen collection, Injections, Intravenous
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.2 ml sucrose 25%Other
Administered on the tongue by a syringe, a half dose two minutes before blood sampling and the other half dose immediately before sampling
0.5 ml sucrose 25%Other
Administered on the tongue by a syringe, a half dose two minutes before blood sampling and the other half dose immediately before sampling
| Study group | Role | What they receive |
|---|---|---|
| 0.2 ml sucrose | Experimental | on 2 occasions within 1 week 0.2 ml sucrose 25% or 0.5 ml sucrose 25% will be given in randomized order to the same infant during blood sampling Receives: Other: 0.2 ml sucrose 25%; Other: 0.5 ml sucrose 25% |
| 0.5 ml sucrose | Experimental | on 2 occasions within 1 week 0.2 ml sucrose 25% or 0.5 ml sucrose 25% will be given in randomized order to the same infant during blood sampling Receives: Other: 0.2 ml sucrose 25%; Other: 0.5 ml sucrose 25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
assessed by Premature Infant Pain Profile-Revised (PIPP-R). Pain score related to the blood sampling will be performed two times: at skin puncture and immediately after the needle has been removed
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionJun 2016
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 Norwegian University of Science and TechnologyThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Lower Umfolozi Regional War Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Håkon Bergseng, MD PhD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344368
- Sponsor's protocol ID
- 2014/2089
- Status last verified
- Jul 2016
- First submitted
- 16 Jan 2015
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Kristoffersen L, Malahleha M, Duze Z, Tegnander E, Kapongo N, Stoen R, Follestad T, Eik-Nes SH, Bergseng H. Randomised controlled trial showed that neonates received better pain relief from a higher dose of sucrose during venepuncture. Acta Paediatr. 2018 Dec;107(12):2071-2078. doi: 10.1111/apa.14567. Epub 2018 Oct 2.
PubMed 30188590
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sucrose on Pain Relief During Venous Blood Sampling in Preterm Infants: a Comparison of Two Different Doses
- ClinicalTrials.gov ID
- NCT02344368
- Acronym / sponsor ID
- 2014/2089
- Conditions
- Pain
- Keywords
- Sucrose, Anesthesia, Blood specimen collection, Injections, Intravenous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Lower Umfolozi Regional War Memorial Hospital
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Jan 2015 (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.
Despite the fact that oral sucrose is the most frequently studied non-pharmacological intervention for procedural pain relief in infants, there is a paucity of data on the minimal effective dose. The aim of this study is to find the minimal effective dose of sucrose to reduce pain during a single venous blood sampling procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.2 ml sucrose | Experimental | Other: 0.2 ml sucrose 25%, Other: 0.5 ml sucrose 25%on 2 occasions within 1 week 0.2 ml sucrose 25% or 0.5 ml sucrose 25% will be given in randomized order to the same infant during blood sampling |
| 0.5 ml sucrose | Experimental | Other: 0.2 ml sucrose 25%, Other: 0.5 ml sucrose 25%on 2 occasions within 1 week 0.2 ml sucrose 25% or 0.5 ml sucrose 25% will be given in randomized order to the same infant during blood sampling |
Who may qualify
- Ages
- Up to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- born preterm
- more than 1000 gram
Key exclusion criteria (4 listed)
- severe intraventricular hemorrhage
- cerebral malformations
- other malformations requiring surgery
- medication that may impair pain expression (opioids, paracetamol, sedatives)
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 |
|---|---|---|
| 0.2 ml sucrose 25%Administered on the tongue by a syringe, a half dose two minutes before blood sampling and the other half dose immediately before sampling | Other | 0.2 ml sucrose, 0.5 ml sucrose |
| 0.5 ml sucrose 25%Administered on the tongue by a syringe, a half dose two minutes before blood sampling and the other half dose immediately before sampling | Other | 0.2 ml sucrose, 0.5 ml sucrose |
Primary outcome
pain
Time frame: 1 week
assessed by Premature Infant Pain Profile-Revised (PIPP-R). Pain score related to the blood sampling will be performed two times: at skin puncture and immediately after the needle has been removed
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 4 Jun 2020.
- Results publication: PubMed 30188590Kristoffersen L, Malahleha M, Duze Z, Tegnander E, Kapongo N, Stoen R, Follestad T, Eik-Nes SH, Bergseng H. Randomised controlled trial showed that neonates received better pain relief from a higher dose of sucrose during venepuncture. Acta Paediatr. 2018 Dec;107(12):2071-2078. doi: 10.1111/apa.14567. Epub 2018 Oct 2.
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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.
Håkon Bergseng, MD PhD study director
Norwegian University of Science and Technology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.2 ml sucrose 25% and 0.5 ml sucrose 25% in people with Pain, run by Norwegian University of Science and Technology at 2 sites in 2 countries.
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 2 inclusion and 4 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 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway, South Africa. 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?
pain (time frame: 1 week). 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 NCT02344368, 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 4 Jun 2020.