AnalgesiaGlucose FGNCT00761059
Analgesic Efficacy of Oral Glucose in Preterm Neonates During Suctioning
A study testing Glucose 20% and Aqua in people with Analgesia, run by University of Cologne at 1 site in Germany.
Trial summary
Nasopharyngeal suctioning is a painful procedure that often becomes necessary in the care of preterm infants under CPAP therapy several times a day. Since the use of analgetic and sedative drugs is accompanied with multiple side effects these are usually being avoided. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Analgesia
- What is being tested?
- Glucose 20% and Aqua
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2008to Dec 2010
- 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
- Preterm newborns (>1500g birth weight) up to a gestational age of 36+6 weeks
- CPAP respiratory therapy
- Parents' given written consent
Who cannot join
- Diseases complicating neuromuscular evaluation.
- Drug abuse by the mother
- Administration of other analgetic or sedative drugs within the previous 48h.
- Participation in another interventional clinical trial within 4 weeks before the beginning of this trial.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Neonatology, Children's Hospital, University of Cologne
Cologne, 50672
Christoph Huenseler, Dr med, 0049-221-478-7190, christoph.huenseler@uni-koeln.de
Katharina Vezyroglou, 0049-221-478-7190, katharina.vezyroglou@uk-koeln.de
About this study
Official title: Prospective, Placebo-Controlled Blinded Clinical Trial to Study the Efficacy of Orally Administered Glucose 20% for Relieving Pain During Nasopharyngeal Suctioning in Preterm Infants > 1500g Under CPAP-Therapy
Nasopharyngeal suctioning is a painful procedure that often becomes necessary in the care of preterm infants under CPAP therapy several times a day. Since the use of analgetic and sedative drugs is accompanied with multiple side effects these are usually being avoided. Glucose 20% has been shown to have an analgesic effect when administered to preterm infants previous to some painful procedures (i.e blood sampling).
In this clinical trial the efficacy of orally administered Glucose 20% for relieving the procedural pain of nasopharyngeal suctioning is tested. The investigators' study has a cross-over design and is to include 40 patients.
- Conditions
- Analgesia
- Being tested
- Glucose 20%, Aqua
- Keywords
- analgesia, infant, premature, glucose, nasopharyngeal suctioning
- Medical subject headings
- Agnosia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose 20%Drug
The oral application of 0,3 ml/kg Glucose 20% 3 minutes before nasopharyngeal suctioning
AquaDrug
The oral application of 0,3 ml/kg Aqua 3 minutes before nasopharyngeal suctioning
| Study group | Role | What they receive |
|---|---|---|
| Glucose 20% | Active comparator | Not described Receives: Drug: Glucose 20% |
| placebo | Placebo comparator | Not described Receives: Drug: Aqua |
What is being measured
The primary outcome is the main question the study is designed to answer.
The PIPP-Score, a validated pain-score, is used to measure the patient's pain
Measured: during nasopharyngeal suctioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Investigators
- Christoph Huenseler, Dr med, Principal investigator, Neonatology, Children's Hospital, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761059
- Sponsor's protocol ID
- Uni-Koeln-905
- Acronym
- Glucose FG
- Status last verified
- Feb 2009
- First submitted
- 24 Sep 2008
- Last updated
- 25 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Placebo-Controlled Blinded Clinical Trial to Study the Efficacy of Orally Administered Glucose 20% for Relieving Pain During Nasopharyngeal Suctioning in Preterm Infants > 1500g Under CPAP-Therapy
- ClinicalTrials.gov ID
- NCT00761059
- Acronym / sponsor ID
- Glucose FG / Uni-Koeln-905
- Conditions
- Analgesia
- Keywords
- analgesia, infant, premature, glucose, nasopharyngeal suctioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 26 Sep 2008 (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.
Nasopharyngeal suctioning is a painful procedure that often becomes necessary in the care of preterm infants under CPAP therapy several times a day. Since the use of analgetic and sedative drugs is accompanied with multiple side effects these are usually being avoided. Glucose 20% has been shown to have an analgesic effect when administered to preterm infants previous to some painful procedures (i.e blood sampling).
In this clinical trial the efficacy of orally administered Glucose 20% for relieving the procedural pain of nasopharyngeal suctioning is tested. The investigators' study has a cross-over design and is to include 40 patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucose 20% | Active comparator | Drug: Glucose 20% |
| placebo | Placebo comparator | Drug: Aqua |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Preterm newborns (>1500g birth weight) up to a gestational age of 36+6 weeks
- CPAP respiratory therapy
- Parents' given written consent
Key exclusion criteria (4 listed)
- Diseases complicating neuromuscular evaluation.
- Drug abuse by the mother
- Administration of other analgetic or sedative drugs within the previous 48h.
- Participation in another interventional clinical trial within 4 weeks before the beginning of this trial.
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 20%The oral application of 0,3 ml/kg Glucose 20% 3 minutes before nasopharyngeal suctioning | Drug | Glucose 20% |
| AquaThe oral application of 0,3 ml/kg Aqua 3 minutes before nasopharyngeal suctioning | Drug | placebo |
Primary outcome
The PIPP-Score, a validated pain-score, is used to measure the patient's pain
Time frame: during nasopharyngeal suctioning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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.
Christoph Huenseler, Dr med principal investigator
Neonatology, Children's Hospital, University of Cologne
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 20% and Aqua in people with Analgesia, run by University of Cologne at 1 site in Germany.
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 3 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: status not confirmed, as of the sponsor's last update on 25 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 Germany. 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?
Contact Christoph Huenseler, Dr (0049-221-478-7190, christoph.huenseler@uni-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The PIPP-Score, a validated pain-score, is used to measure the patient's pain (time frame: during nasopharyngeal suctioning). 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 25 Feb 2009.