Status:

COMPLETED

Evaluation of Analgesia With EMLA and Glucose Oral Solution

Lead Sponsor:

Federal University of Minas Gerais

Conditions:

Pain

Eligibility:

All Genders

1-7 years

Phase:

PHASE4

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 glucos...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2009

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT00808054

Start Date

November 1 2008

End Date

December 1 2009

Last Update

July 25 2014

Active Locations (1)

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1

Department of Neonatology of Julia Kubitschek Hospital

Belo Horizonte, Minas Gerais, Brazil