Status:
COMPLETED
Randomised Trial of Eutectic Mixture of Local Anaesthetics Cream and Oral Sucrose Solution for Venepuncture
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Pain
Eligibility:
All Genders
26-37 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- preterm infants (gestational age between 26 and 37 weeks)
- programmed venepuncture
- APGAR score (M5)≥ 7
- enteral feeding
- written parental consent
Exclusion
- infant requiring oxygen
- analgesia or sedation or drugs causing methaemoglobinaemia
- congenital porphyria
- G6PD deficit
- multi organ failure
- convulsion
- dermatosis
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00470080
Start Date
June 1 2007
End Date
November 1 2007
Last Update
May 4 2011
Active Locations (1)
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1
CHU Armand Trousseau
Paris, France, 75012