PainPhase 3NCT00713726
Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants
A Phase 3 study testing FentanyL and Tramadol in people with Pain and Neonatal Infections, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
In newborn infants submitted to surgical procedures, tramadol may provide an effective analgesia and decrease the time on mechanical ventilation support and the time to achieve full enteral feeding. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Pain, Neonatal Infections, Analgesia
- What is being tested?
- FentanyL and Tramadol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2006to Jul 2008
- Phase
- Phase 3
- 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
- Infant 0-28 days of life with indication of large or medium surgical procedure (definition according to the American College of Cardiology, American Heart Association - 2002)
Who cannot join
- Death or hospital discharge until 72 hours after surgical procedure
- New surgery until 72 hours after the studied surgical procedure
- Proved bacterial infection before surgery
- Ambiguous genitalia
- Chromosomal syndromes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Operatory Analgesia in Newborn Infants: a Comparative Study of Fentanyl Versus Tramadol
In newborn infants submitted to surgical procedures, tramadol may provide an effective analgesia and decrease the time on mechanical ventilation support and the time to achieve full enteral feeding.
- Conditions
- Pain, Neonatal Infections, Analgesia
- Being tested
- FentanyL, Tramadol
- Keywords
- Pain, Analgesia, Newborn Infant, Opioids, Side-effects, Intensive care, Postoperative
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanyLDrug
Fentanyl: 1 µg/kg/h for preterm infants and 2 µg/kg/h for term infants for 48 hours and than gradually decrease until interruption of the drug.
TramadolDrug
Tramadol: 0.1 mg/kg/h for preterm infants and 0.2 mg/kg/h for term infants for 48 hours and than gradually decrease until interruption of the drug.
| Study group | Role | What they receive |
|---|---|---|
| F | Active comparator | Patients that received continued infusion of fentanyl at a steady dose for the first 48 hours and, then, doses were gradually decreases until stop Receives: Drug: FentanyL |
| T | Experimental | Patients that received continued infusion of tramadol at a steady dose for the first 48 hours and, then, doses were gradually decreases until stop Receives: Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment wuth CRIES and NFCS pain scales during the first 72 hours after surgical procedure
Measured: Every 2-4h during the first 72 hours after surgical procedure
Secondary outcomes (2)
Time between surgical procedure and successful extubation
Measured: Hospital stay
Time between surgical procedure and achievement of 100 mL/kg of enteral feeding
Measured: hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startJan 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Albert B. Sabin Vaccine Institute
- Investigators
- Ruth Guinsburg, MD, Study director, Federal University of São PauloAna Julia C Alencar, Principal investigator, Federal university of são Paulo and Albert Sabin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713726
- Sponsor's protocol ID
- 1386/06
- Status last verified
- Jul 2008
- First submitted
- 9 Jul 2008
- Last updated
- 11 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alencar AJ, Sanudo A, Sampaio VM, Gois RP, Benevides FA, Guinsburg R. Efficacy of tramadol versus fentanyl for postoperative analgesia in neonates. Arch Dis Child Fetal Neonatal Ed. 2012 Jan;97(1):F24-9. doi: 10.1136/adc.2010.203851. Epub 2011 Apr 5.
PubMed 21471025
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operatory Analgesia in Newborn Infants: a Comparative Study of Fentanyl Versus Tramadol
- ClinicalTrials.gov ID
- NCT00713726
- Acronym / sponsor ID
- 1386/06
- Conditions
- Pain, Neonatal Infections, Analgesia
- Keywords
- Pain, Analgesia, Newborn Infant, Opioids, Side-effects, Intensive care, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Albert B. Sabin Vaccine Institute
- Study start
- Jan 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 11 Jul 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.
In newborn infants submitted to surgical procedures, tramadol may provide an effective analgesia and decrease the time on mechanical ventilation support and the time to achieve full enteral feeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F | Active comparator | Drug: FentanyLPatients that received continued infusion of fentanyl at a steady dose for the first 48 hours and, then, doses were gradually decreases until stop |
| T | Experimental | Drug: TramadolPatients that received continued infusion of tramadol at a steady dose for the first 48 hours and, then, doses were gradually decreases until stop |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infant 0-28 days of life with indication of large or medium surgical procedure (definition according to the American College of Cardiology, American Heart Association - 2002)
Key exclusion criteria (5 listed)
- Death or hospital discharge until 72 hours after surgical procedure
- New surgery until 72 hours after the studied surgical procedure
- Proved bacterial infection before surgery
- Ambiguous genitalia
- Chromosomal syndromes
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 |
|---|---|---|
| FentanyLFentanyl: 1 µg/kg/h for preterm infants and 2 µg/kg/h for term infants for 48 hours and than gradually decrease until interruption of the drug. | Drug | F |
| TramadolTramadol: 0.1 mg/kg/h for preterm infants and 0.2 mg/kg/h for term infants for 48 hours and than gradually decrease until interruption of the drug. | Drug | T |
Primary outcome
Pain assessment wuth CRIES and NFCS pain scales during the first 72 hours after surgical procedure
Time frame: Every 2-4h during the first 72 hours after surgical procedure
2 secondary outcomes
Time between surgical procedure and successful extubation
Time frame: Hospital stay
Time between surgical procedure and achievement of 100 mL/kg of enteral feeding
Time frame: hospital stay
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 11 Jul 2008.
- Derived from this study: PubMed 21471025Alencar AJ, Sanudo A, Sampaio VM, Gois RP, Benevides FA, Guinsburg R. Efficacy of tramadol versus fentanyl for postoperative analgesia in neonates. Arch Dis Child Fetal Neonatal Ed. 2012 Jan;97(1):F24-9. doi: 10.1136/adc.2010.203851. Epub 2011 Apr 5.
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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.
Ruth Guinsburg, MD study director
Federal University of São Paulo
Ana Julia C Alencar principal investigator
Federal university of são Paulo and Albert Sabin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FentanyL and Tramadol in people with Pain and Neonatal Infections, run by Federal University of São Paulo 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 1 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 11 Jul 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 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pain assessment wuth CRIES and NFCS pain scales during the first 72 hours after surgical procedure (time frame: Every 2-4h during the first 72 hours after surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00713726, which also lists 1 linked publication.
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 11 Jul 2008.