The Effects of EMLA Cream and Cold Application on Pain, Fear and Vital Signs Before Chest Tube Removal in Children

Istanbul Medeniyet University

Status: Enrolling

Conditions: Pain Management; Children; Chest Tube Removal

Treatments: Drug: EMLA Cream; Procedure: Cold application

Study type: Interventional

Funder types: Other

Identifiers

NCT06913855

2023-61

Details and patient eligibility

About

This study is being conducted to determine the effect of EMLA cream and cold application on pain, fear and vital signs before chest tube removal in children aged 7-18 years.

Full description

A chest tube is a device used to drain air or fluid from the pleural cavity under sterile conditions by inserting a thin or thick tube. Chest tubes adhere to the endothelium of the chest cavity after insertion and while in place. For this reason, the pulling force applied when they are removed breaks these adhesions and causes intense, localised and transient acute pain. Chest tube removal pain, defined as one of the patient's worst life experiences related to the surgical procedure, is an iatrogenic pain caused by an invasive procedure. Therefore, chest tube removal is a painful, anxious and frightening experience for the patient. There are few studies of pharmacological and non-pharmacological methods of pain control during chest tube removal in children. However, the management of pain associated with surgical procedures in childhood is very important for the management of pain, anxiety and fear that children will experience with future medical procedures.

Enrollment: 72 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having two chest tubes (mediastinal/pleural) placed after open heart surgery
• Turkish literate
• With stable vital signs
• Willing to participate in the research

Exclusion criteria

• Experience with chest tube removal procedure
• Using analgesics other than routine procedures before the procedure
• Children receiving mechanical ventilation support
• Children who have complications in the postoperative period (heart and respiratory failure, repeated surgery, etc.)
• Children with a mental disability, perception problem, visual and hearing impairment
• Children with communication problems. • Children with cold allergies

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 3 patient groups

Control

No Intervention group

Description:

The chest tube removal procedure will be performed according to clinical routine practice.

EMLA cream

Experimental group

Description:

EMLA cream will be applied to the chest tube area 3 hours before the chest tube removal procedure. Then, the chest tube removal procedure will be performed.

Treatment:

Drug: EMLA Cream

Cold application

Experimental group

Description:

Before the chest tube removal procedure, an ice cube pack will be applied to the chest tube area. Cold application will continue until the skin temperature drops to 13.0 degrees. Then the chest tube removal procedure will be performed.

Treatment:

Procedure: Cold application