Evaluation of Analgesia With EMLA and Glucose Oral Solution in Preterm Neonates During Arterial Puncture and PICC Installation
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|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|
- Compare analgesic efficacy of EMLA versus oral glucose [ Time Frame: From the first to seven day of life ] [ Designated as safety issue: Yes ]
- Evaluate analgesic synergism of EMLA versus oral glucose [ Time Frame: First to seven day of life ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
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.
|Contact: Yerkes Pereira Silva, PhDfirstname.lastname@example.org|
|Contact: Juliana Oliveira Marcatto, RNemail@example.com|
|Department of Neonatology of Julia Kubitschek Hospital||Recruiting|
|Belo Horizonte, Minas Gerais, Brazil|
|Contact: Juliana O Marcatto, RN 00553186860470 firstname.lastname@example.org|
|Principal Investigator: Juliana O Marcatto, RN|
|Principal Investigator:||Yerkes Pereira Silva, PhD||Federal University of Minas gerai|