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NCT Number: NCT06913855

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

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.

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Key information

Conditions

Chest Tube Removal Agnosia Children Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medeniyet University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMLA cream

Drug

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.

Cold application

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 6, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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