Evaluation of Analgesia With EMLA and Glucose Oral Solution

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: EMLA

• Registration Number: NCT00808054
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-12
• Study First Submitted QC: 2008-12-12
• Study First Posted: 2008-12-15
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-24
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucose and EMLA	EMLA	Received glucose oral and topical EMLA
Glucose and placebo	EMLA	Received glucose and no EMLA
Oral placebo and EMLA	EMLA	Received oral placebo and EMLA

Primary Outcome Measures

Name	Time	Method
Compare analgesic efficacy of EMLA versus oral glucose	From the first to seven day of life

Secondary Outcome Measures

Name	Time	Method
Evaluate analgesic synergism of EMLA versus oral glucose	First to seven day of life

Trial Locations

Locations (1)

Department of Neonatology of Julia Kubitschek Hospital; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil