Evaluation of Analgesia With EMLA and Glucose Oral Solution in Preterm Neonates During Arterial Puncture and PICC Installation - Full Text View

Sponsored by:	Federal University of Minas Gerais
Information provided by:	Federal University of Minas Gerais
ClinicalTrials.gov Identifier:	NCT00808054

Purpose

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.

Condition	Intervention	Phase
Prematurity	Drug: EMLA	Phase IV

MedlinePlus related topics: Anesthesia

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:

Compare analgesic efficacy of EMLA versus oral glucose [ Time Frame: From the first to seven day of life ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate analgesic synergism of EMLA versus oral glucose [ Time Frame: First to seven day of life ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	November 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

0.5g topical EMLA

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.

Eligibility

Ages Eligible for Study:	up to 7 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808054

Contacts

Contact: Yerkes Pereira Silva, PhD	00553199933384	yerkesps@uol.com
Contact: Juliana Oliveira Marcatto, RN	00553186860470	julianamarcatto@uol.com.br

Locations

Brazil, Minas Gerais
Department of Neonatology of Julia Kubitschek Hospital	Recruiting
Belo Horizonte, Minas Gerais, Brazil
Contact: Juliana O Marcatto, RN 00553186860470 julianamarcatto@uol.com.br
Principal Investigator: Juliana O Marcatto, RN

Sponsors and Collaborators

Federal University of Minas Gerais

Investigators

Principal Investigator:

Yerkes Pereira Silva, PhD

Federal University of Minas gerai

More Information

Publications:

Lehr VT, Taddio A. Topical anesthesia in neonates: clinical practices and practical considerations. Semin Perinatol. 2007 Oct;31(5):323-9. Review.

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.

Deshmukh 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.

Responsible Party:	Federal University of Minas Gerais ( Yerkes Pereira e Silva )
Study ID Numbers:	CAAE0049028720308
Study First Received:	December 12, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00808054 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Minas Gerais:

Pain
preterm neonate
pain assessment
EMLA
oral glucose

Study placed in the following topic categories:

EMLA
Prilocaine
Lidocaine
Central Nervous System Depressants

Anesthetics
Pain
Peripheral Nervous System Agents
Anesthetics, Local

Additional relevant MeSH terms:

EMLA
Anesthetics, Combined
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants

Anesthetics
Peripheral Nervous System Agents
Central Nervous System Agents
Anesthetics, Local
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009