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

NCT00470080 | Completed Phase 4

• 1 other identifier: P060501
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

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.

Outcome Measures

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.

  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

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.

  in the 24 hours

Study Arms (1)

1

EXPERIMENTAL

venepuncture

Procedure: venepuncture

Interventions

venepuncture PROCEDURE

venepuncture

1

Eligibility Criteria

• Age: 26 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CHU Armand Trousseau

Paris, 75012, France

Location

Related Publications (2)

• 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. doi: 10.1136/fn.89.1.f17. No abstract available.

  PMID: 14711847 RESULT

• 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. doi: 10.1136/fn.78.2.f138.

  PMID: 9577286 RESULT

MeSH Terms

Conditions

Pain; Premature Birth

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Valérie BIRAN, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 4, 2007
• First Posted: May 7, 2007
• Study Start: June 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 4, 2011

Record last verified: 2007-05

Locations

FR (1)