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

Phase 4

Completed

• Conditions: Pain
• Interventions: Procedure: venepuncture

• Registration Number: NCT00470080
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Status Verified: 2007-05
• Study First Submitted: 2007-05-04
• Study First Submitted QC: 2007-05-04
• Study First Posted: 2007-05-07
• Study Start: 2007-06
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Last Update Submitted: 2011-05-03
• Last Update Posted: 2011-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• preterm infants (gestational age between 26 and 37 weeks)
• programmed venepuncture
• APGAR score (M5)≥ 7
• enteral feeding
• written parental consent

Read More

Exclusion Criteria

• infant requiring oxygen
• analgesia or sedation or drugs causing methaemoglobinaemia
• congenital porphyria
• G6PD deficit
• multi organ failure
• convulsion
• dermatosis

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	venepuncture	venepuncture

Primary Outcome Measures

Name	Time	Method
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.	in 24 hours	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

Name	Time	Method
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.	in the 24 hours	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.

Trial Locations

Locations (1)

CHU Armand Trousseau; 🇫🇷 Paris, France