Evaluation of Analgesia With EMLA and Glucose Oral Solution

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: EMLA

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil
      • Department of Neonatology of Julia Kubitschek Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 1 week (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glucose and EMLA; Received glucose oral and topical EMLA	Drug: EMLA; 0.5g topical EMLA; Other Names: Lidocaine and prilocaine cream
Experimental: Glucose and placebo; Received glucose and no EMLA	Drug: EMLA; 0.5g topical EMLA; Other Names: Lidocaine and prilocaine cream
Experimental: Oral placebo and EMLA; Received oral placebo and EMLA	Drug: EMLA; 0.5g topical EMLA; Other Names: Lidocaine and prilocaine cream

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Principal Investigator: Yerkes Pereira Silva, PhD, Federal University of Minas gerai

Publications and helpful links

General Publications

• Taddio A, Ohlsson A, Einarson TR, Stevens B, Koren G. A systematic review of lidocaine-prilocaine cream (EMLA) in the treatment of acute pain in neonates. Pediatrics. 1998 Feb;101(2):E1. doi: 10.1542/peds.101.2.e1.
• Lehr VT, Taddio A. Topical anesthesia in neonates: clinical practices and practical considerations. Semin Perinatol. 2007 Oct;31(5):323-9. doi: 10.1053/j.semperi.2007.07.008.
• Deshmukh LS, Udani RH. Analgesic effect of oral glucose in preterm infants during venipuncture--a double-blind, randomized, controlled trial. J Trop Pediatr. 2002 Jun;48(3):138-41. doi: 10.1093/tropej/48.3.138.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: December 12, 2008
• First Submitted That Met QC Criteria: December 12, 2008
• First Posted (Estimate): December 15, 2008

Study Record Updates

• Last Update Posted (Estimate): July 25, 2014
• Last Update Submitted That Met QC Criteria: July 24, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Pain; pain assessment; preterm neonate; EMLA; oral glucose
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Prilocaine
• Other Study ID Numbers: CAAE0049028720308