Pain Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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