Clinical trial NCT06913855: The Effects of EMLA Cream and Cold Application on Pain, Fear and Vital Signs Before Chest Tube Removal in Children
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chest Tube Removal
Children
Pain Management
Keywords: Chest tube removal
Children
Pain management
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 72
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Procedural pain score- Wong-Baker FACES Pain Rating Scale
timeFrame: 3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure
Secondary outcomes:
measure: Procedural fear score- Children's Fear Scale (CFS)
timeFrame: 3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure
measure: Oxygen saturation
timeFrame: 3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure
measure: Pulse rate
timeFrame: 3 hours before the procedure, immediately before the procedure, 1 minute after the procedure and 5 minutes after the procedure
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
Study officials:
affiliation: Istanbul Medeniyet University
name: Aynur Aytekin Ozdemir
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.