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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural fear score- Children's Fear Scale (CFS) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aynur Aytekin Ozdemir | Istanbul Medeniyet University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medeniyet University | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10781447 | Result | 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. | |
| 34387216 | Result | 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. |
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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.
July through December of 2026
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.
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077442 | Lidocaine, Prilocaine Drug Combination |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 |
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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.
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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).
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| 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. |
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| Oxygen saturation | 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 | 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D011318 | Prilocaine |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |