Clinical trial NCT00470080: Randomised Trial of Eutectic Mixture of Local Anaesthetics Cream and Oral Sucrose Solution for Venepuncture
Official title: Randomised Trial of Eutectic Mixture of Local Anaesthetics Cream and Oral Sucrose Solution for Venepuncture in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Venepuncture
Pain
Emla cream
Oral sucrose solution
Premature infant
Premature infant admitted to the care baby unit were
included in the study.
Programed venepuncture is performed with analgesia.
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-05-07
Enrollment: 80
Sex: ALL
Minimum age (years): 26
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: in 24 hours
Secondary outcomes:
measure: 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.
timeFrame: in the 24 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: CHU Armand Trousseau
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Valérie BIRAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.