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NCT Number: NCT00470080

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

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.

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Key information

Conditions

Pain Female Urogenital Diseases and Pregnancy Complications Neurologic Manifestations Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Urogenital Diseases

Age range

26 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Armand Trousseau

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venepuncture

Procedure

venepuncture

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: VIEP

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
May 7, 2007
Registry last updated
May 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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