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

Not Applicable

Recruiting

• Conditions: Chest Tube Removal; Children; Pain Management
• Interventions: Drug: EMLA Cream; Procedure: Cold application

• Registration Number: NCT06913855
• Lead Sponsor: Istanbul Medeniyet University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-03-30
• Study First Submitted QC: 2025-03-30
• Status Verified: 2025-04
• Study Start: 2025-04-05
• Study First Posted: 2025-04-06
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2025-07-15
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMLA cream	EMLA Cream	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.
Cold application	Cold application	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.

Primary Outcome Measures

Name	Time	Method
Procedural pain score- Wong-Baker FACES Pain Rating Scale	3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure	The scale is used to diagnose pain in children aged 3-18 years. It consists of six facial expressions, each one representing an increasing degree of pain scored on a scale 0 to 5 from left to right. The first face is a happy face representing "no pain=0" while the last face is a crying face representing "the worst pain imaginable=5". Higher scores indicate low pain tolerance. Participants are asked to choose the facial expression that best represents their pain.

Secondary Outcome Measures

Name	Time	Method
Oxygen saturation	3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure	Children will be connected to a pulse oximeter monitor; oxygen saturation will be monitored before, during and after the procedure.
Procedural fear score- Children's Fear Scale (CFS)	3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure	The CFS was developed to measure fear and anxiety in children. It consists of five facial expressions that represent a range from neutral to extreme fear. It is scored between 0 and 4. Both researchers and family members can use the CFS to measure fear and anxiety in children before and during procedure.
Pulse rate	3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure	Children will be connected to a pulse oximeter monitor; their pulse rate will be monitored before, during and after the procedure.

Trial Locations

Locations (1)

Istanbul Medeniyet University; 🇹🇷 Istanbul, Turkey