Evaluation of Analgesia With EMLA and Glucose Oral Solution | NCT00808054

Studies
Evaluation of Analgesia With EMLA and Glucose Oral Solution

NCT00808054

Sponsor

Federal University of Minas Gerais

Status

Completed

Last Update Posted

Jul 25, 2014Estimated

Enrollment

60Actual

Phase

Phase 4

Conditions

Pain

Interventions

EMLA

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Dec 12, 2008

First Submission Date that Met QC Criteria

Dec 12, 2008

First Posted Date

Dec 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2014

Last Update Posted Date

Jul 25, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Renato Santiago Gomez, PhD, Federal University of Minas GeraisPrincipal Investigator

Lead Sponsor

Federal University of Minas GeraisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glucose and EMLA	Experimental	Received glucose oral and topical EMLA	Drug: EMLA
Glucose and placebo	Experimental	Received glucose and no EMLA	Drug: EMLA
Oral placebo and EMLA	Experimental	Received oral placebo and EMLA	Drug: EMLA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EMLA	Drug	0.5g topical EMLA	Glucose and EMLA Glucose and placebo Oral placebo and EMLA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compare analgesic efficacy of EMLA versus oral glucose		From the first to seven day of life

Secondary Outcomes

Measure	Description	Time Frame
Evaluate analgesic synergism of EMLA versus oral glucose		First to seven day of life

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
Treatment with agents to induce methemoglobinemia
Mechanical ventilation in patients using opioids
Clinical diagnosis of neuromuscular dysfunction
Any contraindication to suction
Urgent procedures

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Hour

Maximum Age

7 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yerkes Pereira Silva, PhD	Federal University of Minas gerai	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neonatology of Julia Kubitschek Hospital		Belo Horizonte	Minas Gerais		Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17905188	Background	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.
9445511	Background	Taddio 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.

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814