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

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00470080

Purpose

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.

Condition	Intervention	Phase
Pain	Procedure: venepuncture	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Randomised Trial of Eutectic Mixture of Local Anaesthetics Cream and Oral Sucrose Solution for Venepuncture in Preterm Infants

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies

Drug Information available for: Sucrose

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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 Measures:

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 ] [ Designated as safety issue: Yes ]
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.

Enrollment:	80
Study Start Date:	June 2007
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 venepuncture	Procedure: venepuncture venepuncture Other Name: venepuncture

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

Ages Eligible for Study:	26 Weeks to 37 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470080

Locations

France
CHU Armand Trousseau
Paris, France, 75012

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Valérie BIRAN, MD

Assistance Publique - Hôpitaux de Paris

More Information

Publications:

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. No abstract available.

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.

Responsible Party:	Yannick VACHER, Department Clinical Research of developpement
ClinicalTrials.gov Identifier:	NCT00470080 History of Changes
Other Study ID Numbers:	P060501
Study First Received:	May 4, 2007
Last Updated:	May 3, 2011
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

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.

Additional relevant MeSH terms:

Anesthetics, Local
EMLA
Lidocaine
Prilocaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Combined
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 12, 2012