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CompletedNCT00808054Updated Jul 25, 2014

Evaluation of Analgesia With EMLA and Glucose Oral Solution

A Phase 4 interventional study of EMLA in Pain, sponsored by Federal University of Minas Gerais. Completed at 1 site in Brazil. Open to participants aged 1 Hour to 7 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-25.

Sponsored by Federal University of Minas Gerais · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
1 Hour to 7 Days
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Pain

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Keywords

  • Pain
  • preterm neonate
  • pain assessment
  • EMLA
  • oral glucose
03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 2,101 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Federal University of Minas Gerais is the lead sponsor of 152 studies on the registry; 18 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Hour to 7 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Glucose and EMLA

    Received glucose oral and topical EMLA

    Drug: EMLA

  • Experimental
    Glucose and placebo

    Received glucose and no EMLA

    Drug: EMLA

  • Experimental
    Oral placebo and EMLA

    Received oral placebo and EMLA

    Drug: EMLA

Interventions

  • DrugEMLA

    Drug pages: Lidocaine · Prilocaine

    0.5g topical EMLA

    Also known as: Lidocaine and prilocaine cream

06

What researchers measure

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

07

Study locations

1 site
  • Department of Neonatology of Julia Kubitschek Hospital
    Belo Horizonte, Minas Gerais, Brazil
08

References and documents

Publications

  • 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. PubMed 17905188 ↗
  • 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. PubMed 9445511 ↗
  • 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. PubMed 12164596 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00808054
Lead sponsor
Federal University of Minas Gerais
Responsible party
Renato Santiago Gomez (PhD, Federal University of Minas Gerais) — Principal investigator
First posted
Dec 15, 2008
Start date
Nov 2008
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Jul 25, 2014

Study contacts

Yerkes Pereira Silva, PhD
principal investigator · Federal University of Minas gerai

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Lidocaine · Prilocaine

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