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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Procedure: venepuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT00470080

P060501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 26 to 37 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 1 patient group

1

Experimental group

Description:

venepuncture

Treatment:

Procedure: venepuncture