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

Condition(s) targeted: Pain

Intervention: venepuncture (Procedure)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Valérie BIRAN, MD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris

Overall contact:
Valérie BIRAN, MD, Phone: +33(0)- 1 44 73 62 91, Email: valerie.biran@trs.aphp.fr

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.

Official title: Randomised Trial of Eutectic Mixture of Local Anaesthetics Cream and Oral Sucrose Solution for Venepuncture in Preterm Infants

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Association of oral sucrose solution and EMLA cream will reduce pain responses in premature infant for venepuncture.A combination of physiological and behavioural responses are used for the measurement of pain in neonates : DAN score and PIPP.

Secondary outcome: Clinical units providing health care in newborns develop written guidelines and protocols for the management of neonatal pain, like venepuncture with the combination of sucrose oral solution and EMLA cream.

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.

Minimum age: 26 Weeks. Maximum age: 37 Weeks. Gender(s): Both.

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

Valérie BIRAN, MD, Phone: +33(0)- 1 44 73 62 91, Email: valerie.biran@trs.aphp.fr

CHU Armand Trousseau, Paris 75012, France

Starting date: June 2007
Ending date: November 2007
Last updated: May 10, 2007