Evaluation of Analgesia With EMLA and Glucose Oral Solution

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808054
• Other study ID #: CAAE0049028720308
• Status: Completed
• Phase: Phase 4
• First received: December 12, 2008
• Last updated: July 24, 2014
• Start date: November 2008
• Est. completion date: December 2009

Study information

• Verified date: July 2014
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• EMLA
0.5g topical EMLA

Locations

Country	Name	City	State
Brazil	Department of Neonatology of Julia Kubitschek Hospital	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View Citation

Lehr VT, Taddio A. Topical anesthesia in neonates: clinical practices and practical considerations. Semin Perinatol. 2007 Oct;31(5):323-9. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare analgesic efficacy of EMLA versus oral glucose		From the first to seven day of life	Yes
Secondary	Evaluate analgesic synergism of EMLA versus oral glucose		First to seven day of life	Yes