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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00470080
First received: May 4, 2007
Last updated: May 3, 2011
Last verified: May 2007
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:
Pharmaceutical Solutions
Anesthetics, Local
EMLA
Lidocaine
Prilocaine
Anesthetics
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anesthetics, Combined
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014