PainNCT00200590
Analgesic Strategies in Newborns Receiving Prostaglandin Therapy
A study testing acetaminophen and nalbuphine, acetaminophen and morphine and acetaminophen and reduced dosage of prostaglandin in people with Pain, run by Nantes University Hospital at 1 site in France.
Trial summary
This is a randomised trial comparing the efficacy of 3 different analgesic strategies in newborns on prostaglandin for ductus dependent congenital heart disease. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Pain
- What is being tested?
- acetaminophen and nalbuphine, acetaminophen and morphine and acetaminophen and reduced dosage of prostaglandin
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2003to Jul 2006
- 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 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Full-term newborn
- Under one month of age
- With ductus dependent congenital heart disease requiring prostaglandin infusion and elevated pain score
Who cannot join
- Contraindication to either morphine, acetaminophen, or nalbuphine
- Other painful condition
- Poor neurological condition
- Cardiac instability requiring urgent surgery
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomised trial comparing the efficacy of 3 different analgesic strategies in newborns on prostaglandin for ductus dependent congenital heart disease.
- Conditions
- Pain
- Being tested
- acetaminophen and nalbuphine, acetaminophen and morphine, acetaminophen and reduced dosage of prostaglandin
- Keywords
- prostaglandin, analgesia, congenital, heart, defect, induced
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetaminophen and nalbuphineDrug
acetaminophen and morphineDrug
acetaminophen and reduced dosage of prostaglandinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Measured: before inclusion and at 8 hours (H8), H24, H48, H72
Secondary outcomes (4)
Incidence of apnea
Need for mechanical ventilation
Incidence of fever
Pattern of feeding (oral, nasogastric [NG] tubing, parenteral nutrition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionJul 2006
- Study completionJul 2006
Why it stopped: More important number of SAE in one arms
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.
- More trials run by Nantes University HospitalThe 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Véronique Gournay, MD, Principal investigator, Nantes UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200590
- Sponsor's protocol ID
- BRD/03/7-D
- Status last verified
- Apr 2008
- First submitted
- 12 Sep 2005
- Last updated
- 21 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Strategies in Newborns Receiving Prostaglandin Therapy
- ClinicalTrials.gov ID
- NCT00200590
- Acronym / sponsor ID
- BRD/03/7-D
- Conditions
- Pain
- Keywords
- prostaglandin, analgesia, congenital, heart, defect, induced
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: More important number of SAE in one arms
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 20 Sep 2005 (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 is a randomised trial comparing the efficacy of 3 different analgesic strategies in newborns on prostaglandin for ductus dependent congenital heart disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Full-term newborn
- Under one month of age
- With ductus dependent congenital heart disease requiring prostaglandin infusion and elevated pain score
Key exclusion criteria (4 listed)
- Contraindication to either morphine, acetaminophen, or nalbuphine
- Other painful condition
- Poor neurological condition
- Cardiac instability requiring urgent surgery
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 |
|---|---|---|
| acetaminophen and nalbuphine | Drug | – |
| acetaminophen and morphine | Drug | – |
| acetaminophen and reduced dosage of prostaglandin | Drug | – |
Primary outcome
Pain score
Time frame: before inclusion and at 8 hours (H8), H24, H48, H72
4 secondary outcomes
Incidence of apnea
Need for mechanical ventilation
Incidence of fever
Pattern of feeding (oral, nasogastric [NG] tubing, parenteral nutrition)
Results and safety
The study was stopped early (reason given: More important number of SAE in one arms). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2008.
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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.
Véronique Gournay, MD principal investigator
Nantes UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acetaminophen and nalbuphine, acetaminophen and morphine and acetaminophen and reduced dosage of prostaglandin in people with Pain, run by Nantes University Hospital at 1 site in France.
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: stopped early, as of the sponsor's last update on 21 Apr 2008. 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 France. 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 was stopped early (reason given: More important number of SAE in one arms). 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 score (time frame: before inclusion and at 8 hours (H8), H24, H48, H72). 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 21 Apr 2008.