PainPhase 2PRPSNCT01201954
Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning
A Phase 2 study testing sucrose in people with Pain, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Evaluate the effectiveness of the use of a 24% sucrose solution for pain management of preterm infants during endotracheal suctioning. Read more about this study
- Who is it for?
- Ages Up to 36 weeks
- Conditions the study is for
- Pain
- What is being tested?
- sucrose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Apr 2011
- Phase
- Phase 2
- 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 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm infants
- over 12 hours of life
- intubated
- clinically stable
- without use of analgesics or sedatives
Who cannot join
- preterms with congenital malformations
- preterms with genetic syndromes
- preterms with Apgar score at 5´<7
- preterms with meningitis
- preterms with diagnosed of necrotizing enterocolitis Ouvir Ler foneticamente
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Agamenon Magalhães, Hospital Barão de Lucena
Recife, Pernambuco
About this study
Official title: Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning: a Randomized Clinical Trial
Evaluate the effectiveness of the use of a 24% sucrose solution for pain management of preterm infants during endotracheal suctioning.
Read the detailed description
Many infants admitted to neonatal intensive care unit (NICU) undergo repeated invasive procedures. Recent studies have shown that the oral sucrose administration to neonates is safe and effective for pain relief during heel stick and venipuncture.Most data suggest the investigation of the effect of sucrose in other painful procedures such as in ventilated newborns.
- Conditions
- Pain
- Being tested
- sucrose
- Keywords
- pain, sucrose, newborn, mechanical ventilation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sucroseDrug
Also called sugar
oral sucrose solution, 24%, 0,5 ml/kg, 2 minutes before start the suctioning sterile water, 0,5 ml/kg, 2 minutes before start the suctioning
| Study group | Role | What they receive |
|---|---|---|
| sucrose | Active comparator | 0,5 ml/kg of sucrose administered 2 minutes prior the procedure Receives: Drug: sucrose |
| sterile water | Placebo comparator | 0,5 ml/kg of sterile water administered 2 minutes prior the procedure Receives: Drug: sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pain score
The tool that will be used is PIPP = Premature Infant Pain Profile. This avaliation begins prior to suctioning until 30 seconds after suctioning. Each infant will be avaliated 2 times (with sucrose and with placebo). The 2 avaliations in the same day.
Measured: within the first twelve hours after clinical stabilization, the PIPP will be done.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2011
- Study completionApr 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Investigators
- Rita A Almeida, postgraduate, Principal investigator, Universidade Federal de PernambucoSônia B Coutinho, Dr., Study director, Universidade Federal de PernambucoPedro I Lira, Dr., Study director, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201954
- Sponsor's protocol ID
- SACAROSE01
- Acronym
- PRPS
- Status last verified
- Sep 2010
- First submitted
- 14 Sep 2010
- Last updated
- 26 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01201954
- Acronym / sponsor ID
- PRPS / SACAROSE01
- Conditions
- Pain
- Keywords
- pain, sucrose, newborn, mechanical ventilation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 15 Sep 2010 (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.
Evaluate the effectiveness of the use of a 24% sucrose solution for pain management of preterm infants during endotracheal suctioning.
Detailed description
Many infants admitted to neonatal intensive care unit (NICU) undergo repeated invasive procedures. Recent studies have shown that the oral sucrose administration to neonates is safe and effective for pain relief during heel stick and venipuncture.Most data suggest the investigation of the effect of sucrose in other painful procedures such as in ventilated newborns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sucrose | Active comparator | Drug: sucrose0,5 ml/kg of sucrose administered 2 minutes prior the procedure |
| sterile water | Placebo comparator | Drug: sucrose0,5 ml/kg of sterile water administered 2 minutes prior the procedure |
Who may qualify
- Ages
- Up to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- preterm infants
- over 12 hours of life
- intubated
- clinically stable
- without use of analgesics or sedatives
Key exclusion criteria (5 listed)
- preterms with congenital malformations
- preterms with genetic syndromes
- preterms with Apgar score at 5´<7
- preterms with meningitis
- preterms with diagnosed of necrotizing enterocolitis Ouvir Ler foneticamente
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 |
|---|---|---|
| sucroseAlso: sugaroral sucrose solution, 24%, 0,5 ml/kg, 2 minutes before start the suctioning sterile water, 0,5 ml/kg, 2 minutes before start the suctioning | Drug | sterile water, sucrose |
Primary outcome
clinical pain score
Time frame: within the first twelve hours after clinical stabilization, the PIPP will be done.
The tool that will be used is PIPP = Premature Infant Pain Profile. This avaliation begins prior to suctioning until 30 seconds after suctioning. Each infant will be avaliated 2 times (with sucrose and with placebo). The 2 avaliations in the same day.
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 26 Apr 2011.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Rita A Almeida, postgraduate principal investigator
Universidade Federal de Pernambuco
Sônia B Coutinho, Dr. study director
Universidade Federal de Pernambuco
Pedro I Lira, Dr. study director
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sucrose in people with Pain, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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 5 inclusion and 5 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 26 Apr 2011. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
clinical pain score (time frame: within the first twelve hours after clinical stabilization, the PIPP will be done.). 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 26 Apr 2011.