Randomised Trial of Eutectic Mixture of Local Anaesthetics Cream and Oral Sucrose Solution for Venepuncture

NCT ID: NCT00470080

Last Updated: 2011-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2007-11-30

Brief Summary

This randomized bicentric trial will investigate the efficacy of topical EMLA cream with oral sucrose solution compared to oral sucrose solution alone before venepuncture in preterm infants.

Detailed Description

Venepuncture is a painful procedure commonly performed in premature infants. Nonpharmacological intervention (oral sucrose solution) can reduce neonatal pain. EMLA cream is an oil in water emulsion of an eutectic mixture of prilocaine and lignocaine; it is an local anesthetic cream. Very few reports have looked at the efficacy of EMLA in preterm infants.

This randomized bicentric trial will investigate the efficacy of topical EMLA cream with oral sucrose solution compared to oral sucrose solution alone before venepuncture in preterm infants.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

venepuncture

Group Type: EXPERIMENTAL

venepuncture

Intervention Type: PROCEDURE

venepuncture

Interventions

venepuncture

venepuncture

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• preterm infants (gestational age between 26 and 37 weeks)
• programmed venepuncture
• APGAR score (M5)≥ 7
• enteral feeding
• written parental consent

Exclusion Criteria

• infant requiring oxygen
• analgesia or sedation or drugs causing methaemoglobinaemia
• congenital porphyria
• G6PD deficit
• multi organ failure
• convulsion
• dermatosis

• Minimum Eligible Age: 26 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Department Clinical Research of developpement

Principal Investigators

Valérie BIRAN, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

CHU Armand Trousseau

Paris, , France

Countries

France

References

Acharya AB, Annamali S, Taub NA, Field D. Oral sucrose analgesia for preterm infant venepuncture. Arch Dis Child Fetal Neonatal Ed. 2004 Jan;89(1):F17-8. doi: 10.1136/fn.89.1.f17. No abstract available.

Reference Type: RESULT

PMID: 14711847 (View on PubMed)

Acharya AB, Bustani PC, Phillips JD, Taub NA, Beattie RM. Randomised controlled trial of eutectic mixture of local anaesthetics cream for venepuncture in healthy preterm infants. Arch Dis Child Fetal Neonatal Ed. 1998 Mar;78(2):F138-42. doi: 10.1136/fn.78.2.f138.

Reference Type: RESULT

PMID: 9577286 (View on PubMed)

Other Identifiers

P060501

Identifier Type: -

Identifier Source: org_study_id