Evaluation of Analgesia With EMLA and Glucose Oral Solution

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pain

Intervention / Treatment
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* Drug: EMLA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucose and EMLA<br>Received glucose oral and topical EMLA | Drug: EMLA<br>* 0.5g topical EMLA<br>* Other names: Lidocaine and prilocaine cream;|
| Experimental: Glucose and placebo<br>Received glucose and no EMLA | Drug: EMLA<br>* 0.5g topical EMLA<br>* Other names: Lidocaine and prilocaine cream;|
| Experimental: Oral placebo and EMLA<br>Received oral placebo and EMLA | Drug: EMLA<br>* 0.5g topical EMLA<br>* Other names: Lidocaine and prilocaine cream;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, preterm neonate, pain assessment, EMLA, oral glucose