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

Tracking Information

First Received Date ^ICMJE

May 4, 2007

Last Updated Date

May 10, 2007

Start Date ^ICMJE

June 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: in 24 hours ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00470080 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. [ Time Frame: in the 24 hours ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Pain

Intervention ^ICMJE

Procedure: venepuncture

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

26 Weeks to 37 Weeks

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Valérie BIRAN, MD

+33(0)- 1 44 73 62 91

valerie.biran@trs.aphp.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00470080

Responsible Party

Study ID Numbers ^ICMJE

P060501

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

CNP (Caisse Nationale de Prévoyance)

Investigators ^ICMJE

Principal Investigator:

Valérie BIRAN, MD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP