PainNCT05323071
Comparison of the Efficacy of Oral Sucrose Administration at Two Different Times of a Painful Procedure in Neonates.
A study testing Sucrose 24% in people with Pain, run by Oihana Lopez Alonso at 1 site in Spain.
Trial summary
The objective of this study is to compare the use of 24% sucrose in pain control in neonates from 32 weeks of gestation onwards according to the time of administration of sucrose in venous and arterial puncture for blood collection. Read more about this study
- Who is it for?
- Ages 32 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Sucrose 24%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2021to 11 Oct 2022
- 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 32 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Neonates whose parents and/or guardians have signed the informed consent form.
Who cannot join
- Neonates connected to invasive mechanical ventilation.
- Neonates presenting any type of neurological alteration or showing signs of irritability prior to the puncture.
- Neonates who have received sedation.
- Neonates presenting withdrawal syndrome.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Araba-Sede Txagorritxu
Vitoria-Gasteiz, Alava, 01009
About this study
Official title: Comparison of the Effectiveness of Administering 24% Oral Sucrose Two Minutes Before Versus at the Same Time in the Performance of a Painful Procedure in the Neonate.
The objective of this study is to compare the use of 24% sucrose in pain control in neonates from 32 weeks of gestation onwards according to the time of administration of sucrose in venous and arterial puncture for blood collection.
- Conditions
- Pain
- Being tested
- Sucrose 24%
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sucrose 24%Other
According to the age of the newborn:
24-26 weeks : 0.1 mL, 27-31weeks : 0.25 mL, 32-36 weeks : 0.5 mL, >37 weeks : 1 mL
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Sucrose will be administered 2 minutes before the puncture following the current protocol of the unit. Venous or arterial puncture will be performed only in case it is required for therapeutic or care purposes. Receives: Other: Sucrose 24% |
| Experimental Group | Experimental | The administration of the sucrose dose is started by means of a syringe. Once 50% of the dose has been administered, puncture will be performed. The remaining 50% will be administered during the puncture. The pacifier will be left in the mouth until the end of the procedure, facilitating the non-nutritive sucking of the neonate. Receives: Other: Sucrose 24% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during a painful procedure
The primary variable is pain, and will be measured by the Premature Infant Pain Profile-Revised (PIPP-R) scale. The score ranges from 0 (no pain or minimal pain) to 21 (maximum pain).
Measured: 15 seconds after extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Sep 2021
- Primary completion14 Feb 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oihana Lopez Alonso
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Oihana Lopez Alonso, Bioaraba Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323071
- Sponsor's protocol ID
- Expte. 2021-025
- Status last verified
- Jan 2023
- First submitted
- 5 Apr 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Administering 24% Oral Sucrose Two Minutes Before Versus at the Same Time in the Performance of a Painful Procedure in the Neonate.
- ClinicalTrials.gov ID
- NCT05323071
- Acronym / sponsor ID
- Expte. 2021-025
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Oihana Lopez AlonsoResearch network
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 12 Apr 2022 (actual)
- 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.
The objective of this study is to compare the use of 24% sucrose in pain control in neonates from 32 weeks of gestation onwards according to the time of administration of sucrose in venous and arterial puncture for blood collection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Sucrose 24%Sucrose will be administered 2 minutes before the puncture following the current protocol of the unit. Venous or arterial puncture will be performed only in case it is required for therapeutic or care purposes. |
| Experimental Group | Experimental | Other: Sucrose 24%The administration of the sucrose dose is started by means of a syringe. Once 50% of the dose has been administered, puncture will be performed. The remaining 50% will be administered during the puncture. The pacifier will be left in the mouth until the end of the procedure, facilitating the non-nutritive sucking of the neonate. |
Who may qualify
- Ages
- 32 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Neonates whose parents and/or guardians have signed the informed consent form.
Key exclusion criteria (4 listed)
- Neonates connected to invasive mechanical ventilation.
- Neonates presenting any type of neurological alteration or showing signs of irritability prior to the puncture.
- Neonates who have received sedation.
- Neonates presenting withdrawal syndrome.
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 |
|---|---|---|
| Sucrose 24%According to the age of the newborn: 24-26 weeks : 0.1 mL, 27-31weeks : 0.25 mL, 32-36 weeks : 0.5 mL, >37 weeks : 1 mL | Other | Control Group, Experimental Group |
Primary outcome
Pain during a painful procedure
Time frame: 15 seconds after extraction
The primary variable is pain, and will be measured by the Premature Infant Pain Profile-Revised (PIPP-R) scale. The score ranges from 0 (no pain or minimal pain) to 21 (maximum pain).
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 20 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 24% in people with Pain, run by Oihana Lopez Alonso at 1 site in Spain.
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 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 20 Jan 2023. 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 Spain. 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 during a painful procedure (time frame: 15 seconds after extraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2023.