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

NCT06913855 | Completed

• 1 other identifier: 2023-61
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Tube Removal; Children; Pain Management

Keywords

Chest tube removal; Children; Pain management

Outcome Measures

Primary Outcomes (1)

• Procedural pain score- Wong-Baker FACES Pain Rating Scale

  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 Outcomes (3)

• 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

• Oxygen saturation

  3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure

• Pulse rate

  3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure

Study Arms (3)

Control

NO INTERVENTION

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

EMLA cream

EXPERIMENTAL

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

Cold application

EXPERIMENTAL

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

Interventions

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.

EMLA cream

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.

Cold application

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• Rosen DA, Morris JL, Rosen KR, Valenzuela RC, Vidulich MG, Steelman RJ, Gustafson RA. Analgesia for pediatric thoracostomy tube removal. Anesth Analg. 2000 May;90(5):1025-8. doi: 10.1097/00000539-200005000-00005.

  PMID: 10781447 BACKGROUND

• Pouraboli B, Mirlashari J, Fakhr AS, Ranjbar H, Ashtari S. The Effect of Facilitated Tucking on the Pain Intensity Induced by Chest Tube Removal in Infants. Adv Neonatal Care. 2022 Oct 1;22(5):467-472. doi: 10.1097/ANC.0000000000000936. Epub 2021 Aug 11.

  PMID: 34387216 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Aynur Aytekin Ozdemir

  Istanbul Medeniyet University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Using the block randomization technique, participants will be divided into 3 groups. A web-based randomization list creation tool will be used to create the blocked randomization list. Control and intervention groups will be coded as A, B and C using the sealed envelope method. Randomization information will be kept from the researcher involved in data collection until data collection begins. The researcher will learn which group each child is in just before the application (researcher blinding). Research data will be entered into the computer database by coding the group name as A, B and C, and statistical analysis will be performed using this coding (statistician blinding).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be assigned to experimental and control groups using block randomization method. Age, sex and procedural fear variables will be used for block randomization. In order to reach the sample size calculated in the study, strata will be repeated two times (2X2X3X2) and 24 children will be included in each group.

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 6, 2025
• Study Start: April 5, 2025
• Primary Completion: July 5, 2025
• Study Completion: July 5, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: July through December of 2026
• 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.

Locations

TU (1)