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Completed

NCT Number: NCT00808054

Evaluation of Analgesia With EMLA and Glucose Oral Solution

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.

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Key information

Age range

1 hour–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Neonatology of Julia Kubitschek Hospital

Belo Horizonte, Minas Gerais, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMLA

Drug

0.5g topical EMLA

Other names: Lidocaine and prilocaine cream

Primary outcomes

  1. Compare analgesic efficacy of EMLA versus oral glucose

    Time frame: From the first to seven day of life

Secondary outcomes

  1. Evaluate analgesic synergism of EMLA versus oral glucose

    Time frame: First to seven day of life

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 15, 2008
Registry last updated
Jul 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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