We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00470080
First Posted: May 7, 2007
Last Update Posted: May 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assistance Publique - Hôpitaux de Paris
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   26 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: May 4, 2007
First Posted: May 7, 2007
Last Update Posted: May 4, 2011
Last Verified: May 2007

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