Evaluation of Analgesia With EMLA and Glucose Oral Solution

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Renato Santiago Gomez, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT00808054
First received: December 12, 2008
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Pain
Drug: EMLA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • Compare analgesic efficacy of EMLA versus oral glucose [ Time Frame: From the first to seven day of life ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate analgesic synergism of EMLA versus oral glucose [ Time Frame: First to seven day of life ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: November 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808054

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

Publications:
Responsible Party: Renato Santiago Gomez, PhD, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT00808054     History of Changes
Other Study ID Numbers: CAAE0049028720308
Study First Received: December 12, 2008
Last Updated: July 24, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Minas Gerais:
Pain
preterm neonate
pain assessment
EMLA
oral glucose

Additional relevant MeSH terms:
Prilocaine
Lidocaine
EMLA
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Anesthetics, Combined

ClinicalTrials.gov processed this record on July 24, 2014