Evaluation of Analgesia With EMLA and Glucose Oral Solution

NCT00808054 | Completed Phase 4 DMC

• 1 other identifier: CAAE0049028720308
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain; preterm neonate; pain assessment; EMLA; oral glucose

Outcome Measures

Primary Outcomes (1)

• Compare analgesic efficacy of EMLA versus oral glucose

  From the first to seven day of life

Secondary Outcomes (1)

• Evaluate analgesic synergism of EMLA versus oral glucose

  First to seven day of life

Study Arms (3)

Glucose and EMLA

EXPERIMENTAL

Received glucose oral and topical EMLA

Drug: EMLA

Glucose and placebo

EXPERIMENTAL

Received glucose and no EMLA

Drug: EMLA

Oral placebo and EMLA

EXPERIMENTAL

Received oral placebo and EMLA

Drug: EMLA

Interventions

EMLA DRUG

0.5g topical EMLA

Also known as: Lidocaine and prilocaine cream

Glucose and EMLA; Glucose and placebo; Oral placebo and EMLA

Eligibility Criteria

• Age: 1 Hour - 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Department of Neonatology of Julia Kubitschek Hospital

Belo Horizonte, Minas Gerais, Brazil

Location

Related Publications (3)

• 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.

  PMID: 17905188 BACKGROUND

• 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.

  PMID: 9445511 BACKGROUND

• 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.

  PMID: 12164596 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Yerkes Pereira Silva, PhD

  Federal University of Minas gerai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: December 15, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 25, 2014

Record last verified: 2014-07

Locations

BR (1)