Use of Local Warming in Children Venipuncture

University of Florence (UNIFI)

Status and phase: Suspended; Early Phase 1

Conditions: Phobia Phlebotomy

Treatments: Other: Emla + Local Warming

Study type: Interventional

Funder types: Other

Identifiers

NCT01543009

UFI2012WARM

Details and patient eligibility

About

The aim of this study is to determine if local application of heat increases the probability of insertion of peripheral venous catheter at the first attempt, reduces the time needed to obtain cannulation and maintains the analgesic effect of Emla in children undergoing peripheral venous cannulation and previously treated with local analgesia with Emla.

Enrollment: 72 estimated patients

Sex: All

Ages: 8 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age between 8 and 13 years
• Intravenous drug therapy prescribed by a physician
• no allergy to lidocaine
• no local skin disease
• absence of burns scars
• child and his/her family are native speaker of Italian
• BMI not lower than 10° centile for sex and age according to the CDC standards

Exclusion criteria

• age of child not included in the age range established for the study
• Intravenous drug therapy not needed
• Presence of an allergy to lidocaine products
• Skin disease
• Presence of burns scars
• The child or his/her family are not native speaker Italian
• BMI lower than 10° centile according to the CDC standards

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Emla + no additional intervention

No Intervention group

Description:

Children in this arm will receive standard preparation of the venipuncture site (local analgesia with Emla) without warming

Emla + Local Warming

Experimental group

Description:

Children in this arm will receive standard preparation of the venipuncture site (local analgesia with Emla) plus warming with a heating pad at 40°C for 5 minutes

Treatment:

Other: Emla + Local Warming