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Evaluation of Analgesia With EMLA and Glucose Oral Solution

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ClinicalTrials.gov Identifier: NCT00808054
Recruitment Status : Completed
First Posted : December 15, 2008
Last Update Posted : July 25, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Pain Drug: EMLA Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official 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
Study Start Date : November 2008
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Glucose and EMLA
Received glucose oral and topical EMLA
Drug: EMLA
0.5g topical EMLA
Other Name: Lidocaine and prilocaine cream
Experimental: Glucose and placebo
Received glucose and no EMLA
Drug: EMLA
0.5g topical EMLA
Other Name: Lidocaine and prilocaine cream
Experimental: Oral placebo and EMLA
Received oral placebo and EMLA
Drug: EMLA
0.5g topical EMLA
Other Name: Lidocaine and prilocaine cream

Outcome Measures

Primary Outcome Measures :
  1. Compare analgesic efficacy of EMLA versus oral glucose [ Time Frame: From the first to seven day of life ]

Secondary Outcome Measures :
  1. Evaluate analgesic synergism of EMLA versus oral glucose [ Time Frame: First to seven day of life ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808054

Department of Neonatology of Julia Kubitschek Hospital
Belo Horizonte, Minas Gerais, Brazil
Sponsors and Collaborators
Federal University of Minas Gerais
Principal Investigator: Yerkes Pereira Silva, PhD Federal University of Minas gerai
More Information

Responsible Party: Renato Santiago Gomez, PhD, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT00808054     History of Changes
Other Study ID Numbers: CAAE0049028720308
First Posted: December 15, 2008    Key Record Dates
Last Update Posted: July 25, 2014
Last Verified: July 2014

Keywords provided by Renato Santiago Gomez, Federal University of Minas Gerais:
preterm neonate
pain assessment
oral glucose

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Combined