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

July 9, 2025 updated by: Aynur Aytekin Ozdemir, Istanbul Medeniyet University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Medeniyet University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
The chest tube removal procedure will be performed according to clinical routine practice.
Experimental: 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.
Drug: EMLA Cream
EMLA cream is applied once, 3 hours before the tube is removed. EMLA cream will be applied by the researcher in a thin layer to an area of 7-10 cm2, with the chest tube entrance to the skin remaining in the center. It will be covered with a Tegaderm transparent film dressing.
Experimental: 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.
Procedure: Cold application
Cold application will be made with an ice cube pack immediately before the chest tube removal procedure. Cold application will be applied to a 7 cm diameter area, with the chest tube entrance to the skin being considered as the center. Skin temperature will be measured with an infrared thermometer and will be ensured to reach 13.0 degrees. Ice pack application is expected to last approximately 9-10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural pain score- Wong-Baker FACES Pain Rating Scale
Time Frame: 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.
3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural fear score- Children's Fear Scale (CFS)
Time Frame: 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.
3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure
Oxygen saturation
Time Frame: 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.
3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure
Pulse rate
Time Frame: 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.
3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medeniyet University

Investigators

  • Study Director: Aynur Aytekin Ozdemir, Istanbul Medeniyet University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2025

Primary Completion (Actual)

July 5, 2025

Study Completion (Actual)

July 5, 2025

Study Registration Dates

First Submitted

March 30, 2025

First Submitted That Met QC Criteria

March 30, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

July 14, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-61

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.

IPD Sharing Time Frame

July through December of 2026

IPD Sharing Access Criteria

Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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