PainPhase 4NCT00808054
Evaluation of Analgesia With EMLA and Glucose Oral Solution
A Phase 4 study testing EMLA in people with Pain, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
In this randomized controlled study the investigators intended to compare analgesic effects of EMLA and/or oral glucose in 60 preterm neonate during arterial function and PICC installation. Read more about this study
- Who is it for?
- Ages 1 hour to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- EMLA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2008to Dec 2009
- Phase
- Phase 4
- 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 1 hour to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age greater than or equal to 28 weeks and less than 37 weeks
- Admission in the neonatal intensive care unit of the hospital Julia Kubtischek
- Clinical indication of collection of blood through arterial puncture or peripherally inserted central catheter
- Neonate in the first week of life (first to seventh day of life);
- Informed consent have to be obtained by parents or guardians.
Who cannot join
- Newborn with broken skin at cream application site;
- Use of sedation or analgesia in the last 72 hours;
- Diagnosis of necrotizing enterocolitis;
- Anemia
- Metabolic acidosis
- Methaemoglobinaemia
Show all 11Show fewer
- Treatment with agents to induce methemoglobinemia
- Mechanical ventilation in patients using opioids
- Clinical diagnosis of neuromuscular dysfunction
- Any contraindication to suction
- Urgent procedures
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Neonatology of Julia Kubitschek Hospital
Belo Horizonte, Minas Gerais
About this study
Official title: Evaluation of Analgesia With the Use of Eutectic Mixture of Local Anesthetics (Lidocaine and Prilocaine) and Oral Solution of Glucose to 25% in Preterm Neonates During Arterial Puncture and / or the Installation of Percutaneous Catheter
In this randomized controlled study the investigators intended to compare analgesic effects of EMLA and/or oral glucose in 60 preterm neonate during arterial function and PICC installation.
Read the detailed description
It is a randomised controlled clinical trial, double blinded, with the purpose to compare the use of eutectic mixture of local anesthetics (lidocaine and prilocaine) and/or the oral solution of glucose 25% in the prevention and treatment of pain in preterm neonates with gestational between 28-37 weeks old.
The pain evaluation will be done using NIPS scale, and also physiologic variables (HR, MAP, oxygen saturation level and crie) during two painful procedures performed in the neonatal intensive care units:arterial puncture (n=30) and peripherally inserted central catheters (n=30). All procedures will have clinical indication and will not be implemented by the researcher.The newborns will be randomized into three groups: A (EMLA and glucose; n=20),B (EMLA AND placebo; n=20) and C (anesthetic cream placebo and oral glucose; n=20).
All newborns will be subjected to some kind of therapeutic intervention, the objective of this study is validate the application of control measures and treatment of pain for these two procedures that cause mild and moderate pain.
- Conditions
- Pain
- Being tested
- EMLA
- Keywords
- Pain, preterm neonate, pain assessment, EMLA, oral glucose
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMLADrug
Also called Lidocaine and prilocaine cream
0.5g topical EMLA
| Study group | Role | What they receive |
|---|---|---|
| Glucose and EMLA | Experimental | Received glucose oral and topical EMLA Receives: Drug: EMLA |
| Glucose and placebo | Experimental | Received glucose and no EMLA Receives: Drug: EMLA |
| Oral placebo and EMLA | Experimental | Received oral placebo and EMLA Receives: Drug: EMLA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare analgesic efficacy of EMLA versus oral glucose
Measured: From the first to seven day of life
Secondary outcomes (1)
Evaluate analgesic synergism of EMLA versus oral glucose
Measured: First to seven day of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Santiago Gomez, Federal University of Minas Gerais
- Investigators
- Yerkes Pereira Silva, PhD, Principal investigator, Federal University of Minas gerai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808054
- Sponsor's protocol ID
- CAAE0049028720308
- Status last verified
- Jul 2014
- First submitted
- 12 Dec 2008
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lehr VT, Taddio A. Topical anesthesia in neonates: clinical practices and practical considerations. Semin Perinatol. 2007 Oct;31(5):323-9. doi: 10.1053/j.semperi.2007.07.008.
PubMed 17905188Taddio A, Ohlsson A, Einarson TR, Stevens B, Koren G. A systematic review of lidocaine-prilocaine cream (EMLA) in the treatment of acute pain in neonates. Pediatrics. 1998 Feb;101(2):E1. doi: 10.1542/peds.101.2.e1.
PubMed 9445511Deshmukh LS, Udani RH. Analgesic effect of oral glucose in preterm infants during venipuncture--a double-blind, randomized, controlled trial. J Trop Pediatr. 2002 Jun;48(3):138-41. doi: 10.1093/tropej/48.3.138.
PubMed 12164596
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Analgesia With the Use of Eutectic Mixture of Local Anesthetics (Lidocaine and Prilocaine) and Oral Solution of Glucose to 25% in Preterm Neonates During Arterial Puncture and / or the Installation of Percutaneous Catheter
- ClinicalTrials.gov ID
- NCT00808054
- Acronym / sponsor ID
- CAAE0049028720308
- Conditions
- Pain
- Keywords
- Pain, preterm neonate, pain assessment, EMLA, oral glucose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Dec 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 this randomized controlled study the investigators intended to compare analgesic effects of EMLA and/or oral glucose in 60 preterm neonate during arterial function and PICC installation.
Detailed description
It is a randomised controlled clinical trial, double blinded, with the purpose to compare the use of eutectic mixture of local anesthetics (lidocaine and prilocaine) and/or the oral solution of glucose 25% in the prevention and treatment of pain in preterm neonates with gestational between 28-37 weeks old.
The pain evaluation will be done using NIPS scale, and also physiologic variables (HR, MAP, oxygen saturation level and crie) during two painful procedures performed in the neonatal intensive care units:arterial puncture (n=30) and peripherally inserted central catheters (n=30). All procedures will have clinical indication and will not be implemented by the researcher.The newborns will be randomized into three groups: A (EMLA and glucose; n=20),B (EMLA AND placebo; n=20) and C (anesthetic cream placebo and oral glucose; n=20).
All newborns will be subjected to some kind of therapeutic intervention, the objective of this study is validate the application of control measures and treatment of pain for these two procedures that cause mild and moderate pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glucose and EMLA | Experimental | Drug: EMLAReceived glucose oral and topical EMLA |
| Glucose and placebo | Experimental | Drug: EMLAReceived glucose and no EMLA |
| Oral placebo and EMLA | Experimental | Drug: EMLAReceived oral placebo and EMLA |
Who may qualify
- Ages
- 1 hour to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Gestational age greater than or equal to 28 weeks and less than 37 weeks
- Admission in the neonatal intensive care unit of the hospital Julia Kubtischek
- Clinical indication of collection of blood through arterial puncture or peripherally inserted central catheter
- Neonate in the first week of life (first to seventh day of life);
- Informed consent have to be obtained by parents or guardians.
Key exclusion criteria (11 listed)
- Newborn with broken skin at cream application site;
- Use of sedation or analgesia in the last 72 hours;
- Diagnosis of necrotizing enterocolitis;
- Anemia
- Metabolic acidosis
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 |
|---|---|---|
| EMLAAlso: Lidocaine and prilocaine cream0.5g topical EMLA | Drug | Glucose and EMLA, Glucose and placebo, Oral placebo and EMLA |
Primary outcome
Compare analgesic efficacy of EMLA versus oral glucose
Time frame: From the first to seven day of life
1 secondary outcome
Evaluate analgesic synergism of EMLA versus oral glucose
Time frame: First to seven day of life
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 25 Jul 2014.
- Background: PubMed 17905188Lehr VT, Taddio A. Topical anesthesia in neonates: clinical practices and practical considerations. Semin Perinatol. 2007 Oct;31(5):323-9. doi: 10.1053/j.semperi.2007.07.008.
- Background: PubMed 9445511Taddio A, Ohlsson A, Einarson TR, Stevens B, Koren G. A systematic review of lidocaine-prilocaine cream (EMLA) in the treatment of acute pain in neonates. Pediatrics. 1998 Feb;101(2):E1. doi: 10.1542/peds.101.2.e1.
- Background: PubMed 12164596Deshmukh LS, Udani RH. Analgesic effect of oral glucose in preterm infants during venipuncture--a double-blind, randomized, controlled trial. J Trop Pediatr. 2002 Jun;48(3):138-41. doi: 10.1093/tropej/48.3.138.
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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.
Yerkes Pereira Silva, PhD principal investigator
Federal University of Minas gerai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EMLA in people with Pain, run by Federal University of Minas Gerais 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 11 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 25 Jul 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Compare analgesic efficacy of EMLA versus oral glucose (time frame: From the first to seven day of life). 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 NCT00808054, which also lists 3 linked publications.
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 Jul 2014.