PainNCT00847028
Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical Trial
A study testing glucose 10%, 20% glucose and glucose 30% in people with Pain, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
This study investigates which concentration of glucose is most effective in reducing pain for venipuncture in the newborn. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain
- What is being tested?
- glucose 10%, 20% glucose and glucose 30%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2007to Apr 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Neonates were included if they had to undergo a venipuncture as part of routine medical care.
Who cannot join
- Unstable neonates with respiratory support as well as neonates with a proven neurological abnormality were excluded.
- Newborns who had been administered sedatives, analgesics or naloxone during the past 48 hours were excluded along with premature infants younger than 32 weeks post menstrual age.
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates which concentration of glucose is most effective in reducing pain for venipuncture in the newborn.
Read the detailed description
This double-blind clinical trial is conducted on a maternity and newborn (N*) ward. Each time, during at least one month, one of the four selected solutions (glucose 10%, 20%, 30% and placebo) will be administered orally, 2 minutes prior to the venipuncture. The pain from the skin puncture will be scored using a validated pain scale (the "Leuven" pain scale).
- Conditions
- Pain
- Being tested
- glucose 10%, 20% glucose, glucose 30%, sterile water
- Keywords
- Newborn, Pain, glucose solution, venipuncture, non-pharmacologic pain relief.
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose 10%Other
2 minutes prior to the venipuncture, a 10% glucose concentration was administered orally
20% glucoseOther
2 minutes prior to the venipuncture, a 20% glucose concentration was administered orally
glucose 30%Other
2 minutes prior to the venipuncture, a 30% glucose concentration was administered orally
sterile waterOther
2 minutes prior to the venipuncture, sterile water was administered orally
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | glucose 10% Receives: Other: glucose 10% |
| 2 | Experimental | glucose 20% Receives: Other: 20% glucose |
| 3 | Experimental | glucose 30% Receives: Other: glucose 30% |
| 4 | Placebo comparator | placebo: sterile water Receives: Other: sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain after venipuncture measured by the Leuven pain scale for newborns
Measured: solution administration- waiting for 2 minutes-then venipuncture and immediate pain scoring
Secondary outcomes (1)
difference in heart rhythm
Measured: heart rhythm measured before painful procedure - heart rythm after venipuncture compared to baseline measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startNov 2007
- Primary completionApr 2009 (estimated)
- Study completionApr 2009 (estimated)
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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Investigators
- Ben Dilen, MSN, Principal investigator, Universiteit Antwerpen + Heilig Hart ziekenhuis Mol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847028
- Sponsor's protocol ID
- HHmol-001
- Other IDs
- (EC NR 7/37/203).
- Status last verified
- Feb 2009
- First submitted
- 17 Feb 2009
- Last updated
- 19 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical Trial
- ClinicalTrials.gov ID
- NCT00847028
- Acronym / sponsor ID
- HHmol-001
- Conditions
- Pain
- Keywords
- Newborn, Pain, glucose solution, venipuncture, non-pharmacologic pain relief.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Apr 2009 (estimated)
- First posted
- 19 Feb 2009 (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.
This study investigates which concentration of glucose is most effective in reducing pain for venipuncture in the newborn.
Detailed description
This double-blind clinical trial is conducted on a maternity and newborn (N*) ward. Each time, during at least one month, one of the four selected solutions (glucose 10%, 20%, 30% and placebo) will be administered orally, 2 minutes prior to the venipuncture. The pain from the skin puncture will be scored using a validated pain scale (the "Leuven" pain scale).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: glucose 10%glucose 10% |
| 2 | Experimental | Other: 20% glucoseglucose 20% |
| 3 | Experimental | Other: glucose 30%glucose 30% |
| 4 | Placebo comparator | Other: sterile waterplacebo: sterile water |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Neonates were included if they had to undergo a venipuncture as part of routine medical care.
Key exclusion criteria (2 listed)
- Unstable neonates with respiratory support as well as neonates with a proven neurological abnormality were excluded.
- Newborns who had been administered sedatives, analgesics or naloxone during the past 48 hours were excluded along with premature infants younger than 32 weeks post menstrual age.
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 |
|---|---|---|
| glucose 10%2 minutes prior to the venipuncture, a 10% glucose concentration was administered orally | Other | 1 |
| 20% glucose2 minutes prior to the venipuncture, a 20% glucose concentration was administered orally | Other | 2 |
| glucose 30%2 minutes prior to the venipuncture, a 30% glucose concentration was administered orally | Other | 3 |
| sterile water2 minutes prior to the venipuncture, sterile water was administered orally | Other | 4 |
Primary outcome
Pain after venipuncture measured by the Leuven pain scale for newborns
Time frame: solution administration- waiting for 2 minutes-then venipuncture and immediate pain scoring
1 secondary outcome
difference in heart rhythm
Time frame: heart rhythm measured before painful procedure - heart rythm after venipuncture compared to baseline measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2009.
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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.
Ben Dilen, MSN principal investigator
Universiteit Antwerpen + Heilig Hart ziekenhuis Mol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glucose 10%, 20% glucose and glucose 30% in people with Pain, run by Universiteit Antwerpen at 1 site in Belgium.
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 2 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: status not confirmed, as of the sponsor's last update on 19 Feb 2009. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 after venipuncture measured by the Leuven pain scale for newborns (time frame: solution administration- waiting for 2 minutes-then venipuncture and immediate pain scoring). 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 19 Feb 2009.