Evaluation of Analgesia With EMLA and Glucose Oral Solution

Federal University of Minas Gerais

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: EMLA

Study type: Interventional

Funder types: Other

Identifiers

NCT00808054

CAAE0049028720308

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1 hour to 7 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Gestational age greater than or equal to 28 weeks and less than 37 weeks
2. Admission in the neonatal intensive care unit of the hospital Julia Kubtischek
3. Clinical indication of collection of blood through arterial puncture or peripherally inserted central catheter
4. Neonate in the first week of life (first to seventh day of life);
5. Informed consent have to be obtained by parents or guardians.

Exclusion criteria

1. Newborn with broken skin at cream application site;
2. Use of sedation or analgesia in the last 72 hours;
3. Diagnosis of necrotizing enterocolitis;
4. Anemia
5. Metabolic acidosis
6. Methaemoglobinaemia
7. Treatment with agents to induce methemoglobinemia
8. Mechanical ventilation in patients using opioids
9. Clinical diagnosis of neuromuscular dysfunction
10. Any contraindication to suction
11. Urgent procedures

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups

Glucose and EMLA

Experimental group

Description:

Received glucose oral and topical EMLA

Treatment:

Drug: EMLA

Glucose and placebo

Experimental group

Description:

Received glucose and no EMLA

Treatment:

Drug: EMLA

Oral placebo and EMLA

Experimental group

Description:

Received oral placebo and EMLA

Treatment:

Drug: EMLA