Trials / Completed
CompletedNCT06913855
The Effects of EMLA Cream and Cold Application on Pain, Fear and Vital Signs Before Chest Tube Removal in Children
The Effects of EMLA Cream and Cold Application on Pain, Fear and Vital Signs Before Chest Tube Removal in Children: a Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Istanbul Medeniyet University · Academic / Other
- Sex
- All
- Age
- 8 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2025-04-05
- Primary completion
- 2025-07-05
- Completion
- 2025-07-05
- First posted
- 2025-04-06
- Last updated
- 2025-07-14
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT06913855. Inclusion in this directory is not an endorsement.