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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00808054

Enrollment

Registered

2008-12-15

Start date

2008-11-30

Completion date

2009-12-31

Last updated

2014-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

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

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.

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.

Interventions

DRUGEMLA

0.5g topical EMLA

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Hours to 7 Days

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

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026